Trial Outcomes & Findings for Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy (NCT NCT04636528)
NCT ID: NCT04636528
Last Updated: 2025-01-29
Results Overview
Shoulder physical function and symptoms will be measured using the shortened Disabilities of the Arm, Shoulder and Hand questionnaire QuickDASH, ranging from 0 (zero;non-disability) to 100 (maximum disability)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
8 weeks after initiation of rehabilitation program
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
Digital Rehabilitation
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
44
|
|
Overall Study
COMPLETED
|
39
|
35
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
Baseline characteristics by cohort
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face PT sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, PTs will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
50.8 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
50.3 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Age, Customized
<25
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
25-40
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Customized
40-60
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Customized
>60
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Woman
|
24 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Man
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
17 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial or biracial
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Body Mass Index, Continuous
|
24.21 Kg/m2
n=99 Participants
|
25.36 Kg/m2
n=107 Participants
|
24.49 Kg/m2
n=206 Participants
|
|
Body Mass Index, Customized
Underweight (<18.5)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Body Mass Index, Customized
Normal (18.5-25)
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Body Mass Index, Customized
Overweight (25-30)
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Body Mass Index, Customized
Obese (30-40)
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Body Mass Index, Customized
Morbidly obese (>40)
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education Level
Some high school, general educational development, or less
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Education Level
Some college or college degree
|
23 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Education Level
Some graduate or graduate degree
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Employment Status
Employed (part-time or full-time)
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Employment Status
Unemployed (seeking opportunities)
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Employment Status
Not employed and not seeking work
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Employment Status
Prefer not to answer
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Weekly exercise levels
None
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Weekly exercise levels
Less than 1 hour
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Weekly exercise levels
Between 1 and 2.5 hours
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Weekly exercise levels
>2.5 hours
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Laterality of shoulder pain
Right
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Laterality of shoulder pain
Left
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Laterality of shoulder pain
Both
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Previous physical therapy
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Previous or scheduled shoulder surgery
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Smoking status
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
QuickDASH
|
25 units on a scale
n=99 Participants
|
25 units on a scale
n=107 Participants
|
25 units on a scale
n=206 Participants
|
|
Pain level - worst
|
6 units on a scale
n=99 Participants
|
5 units on a scale
n=107 Participants
|
6.00 units on a scale
n=206 Participants
|
|
Pain level - least
|
1.00 units on a scale
n=99 Participants
|
2.00 units on a scale
n=107 Participants
|
1.00 units on a scale
n=206 Participants
|
|
Pain level - average
|
4.00 units on a scale
n=99 Participants
|
5.00 units on a scale
n=107 Participants
|
4.00 units on a scale
n=206 Participants
|
|
Anxiety
|
3.00 units on a scale
n=99 Participants
|
2.00 units on a scale
n=107 Participants
|
2.00 units on a scale
n=206 Participants
|
|
Depression
|
3.00 units on a scale
n=99 Participants
|
2.00 units on a scale
n=107 Participants
|
3.00 units on a scale
n=206 Participants
|
|
Surgery Intent
|
0.00 percentage
n=99 Participants
|
1.00 percentage
n=107 Participants
|
0.00 percentage
n=206 Participants
|
|
Comorbidities - High blood pressure
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Comorbidities - High blood sugar or diabetes
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Comorbidities - Cardiac conditions
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Comorbidities - Respiratory conditions
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Comorbidities - None
|
32 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Shoulder physical function and symptoms will be measured using the shortened Disabilities of the Arm, Shoulder and Hand questionnaire QuickDASH, ranging from 0 (zero;non-disability) to 100 (maximum disability)
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
|
15.5 units on a scale
Interval 7.7 to 23.2
|
13.1 units on a scale
Interval 5.8 to 20.3
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your worst pain in the last 24 hours?".
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Change in Shoulder Pain - Worst Pain Level
|
2.6 units on a scale
Interval 2.2 to 3.0
|
1.5 units on a scale
Interval 1.2 to 1.8
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Measured through the following question: "What do you think are the chances you will get shoulder surgery in the next 12 months, in %?". Minimum and maximum values of the scale are respectively 0 and 100%, with lower values representing a lower chance.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Surgery Intent
|
6.3 percentage
Interval 0.0 to 23.2
|
7.2 percentage
Interval 0.0 to 25.1
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Anxiety
|
2.8 units on a scale
Interval 2.1 to 3.5
|
2.2 units on a scale
Interval 1.7 to 2.7
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who completed the allocated digital or conventional interventions.
Measured through the following question: "On a scale from 0 to 10, how likely would you recommend this program to a friend or colleague?". Minimum value is zero and maximum is 10. Higher scores translate higher satisfaction.
Outcome measures
| Measure |
Digital Rehabilitation
n=39 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=35 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Patient Satisfaction With Intervention
|
8 units on a scale
Interval 5.0 to 10.0
|
10 units on a scale
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your least pain in the last 24 hours?".
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Change in Shoulder Pain - Least Pain Level
|
0.7 units on a scale
Interval 0.6 to 0.7
|
0.7 units on a scale
Interval 0.5 to 0.7
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your pain over the last 7 days?".
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Change in Shoulder Pain - Average Pain Level
|
2.1 units on a scale
Interval 1.9 to 2.3
|
1.5 units on a scale
Interval 1.4 to 1.7
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Depression
|
2.7 units on a scale
Interval 2.0 to 3.4
|
1.6 units on a scale
Interval 1.3 to 1.9
|
SECONDARY outcome
Timeframe: Program-endRate of patients who dropout from the program
Outcome measures
| Measure |
Digital Rehabilitation
n=46 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=44 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Dropout Rate
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Number of sessions performed at program-end
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Total Sessions
|
26.1 sessions
Standard Deviation 11.6
|
13.4 sessions
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Between baseline and 8 weeks.Population: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Total number of minutes spent doing exercise sessions.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
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|---|---|---|
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Treatment Intensity
|
461.6 minutes
Standard Deviation 218.2
|
393.9 minutes
Standard Deviation 118.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.
Number of sessions performed per week in the 8-week rehabilitation program
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=41 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Frequency of Sessions Per Week
|
3.3 sessions per week
Standard Deviation 1.4
|
1.68 sessions per week
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Between baseline and 8 weeks.Number of participants that completed the 8 week program.
Outcome measures
| Measure |
Digital Rehabilitation
n=46 Participants
Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist
Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
|
Conventional Rehabilitation
n=44 Participants
Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions
Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
|
|---|---|---|
|
Retention Rate
|
39 Participants
|
35 Participants
|
Adverse Events
Digital Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place