Trial Outcomes & Findings for Scoliosis-Specific Exercises for At-Risk AIS Curves (NCT NCT02807545)
NCT ID: NCT02807545
Last Updated: 2025-01-22
Results Overview
Measured by the number of participants enrolled through study completion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
through study completion up to 45 months
Results posted on
2025-01-22
Participant Flow
Participant milestones
| Measure |
Physical Therapy Exercise Group
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
29
|
|
Overall Study
COMPLETED
|
35
|
22
|
|
Overall Study
NOT COMPLETED
|
34
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Scoliosis-Specific Exercises for At-Risk AIS Curves
Baseline characteristics by cohort
| Measure |
Physical Therapy Exercise Group
n=35 Participants
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
n=22 Participants
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
11.6 years
STANDARD_DEVIATION 1.1 • n=99 Participants
|
12.5 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
11.9 years
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
28 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
22 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
AIS Risser 0 curves 12-24 degrees
|
16.2 degrees
STANDARD_DEVIATION 2.5 • n=99 Participants
|
17.1 degrees
STANDARD_DEVIATION 2.9 • n=107 Participants
|
16.6 degrees
STANDARD_DEVIATION 2.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: through study completion up to 45 monthsMeasured by the number of participants enrolled through study completion.
Outcome measures
| Measure |
Physical Therapy Exercise Group
n=69 Participants
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
n=29 Participants
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
|---|---|---|
|
Overall Recruitment Rate
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: after 1 yearMeasured by the number of prescribed hours of physical therapy sessions attended after 1 year
Outcome measures
| Measure |
Physical Therapy Exercise Group
n=35 Participants
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
|---|---|---|
|
Treatment Attendance in the SSE Group
|
9.7 hours
Standard Deviation 1.7
|
—
|
PRIMARY outcome
Timeframe: 1 yearMeasured by the percentage of prescribed exercises completed from baseline to 1 year
Outcome measures
| Measure |
Physical Therapy Exercise Group
n=35 Participants
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
|---|---|---|
|
Home Exercise Adherence in the SSE Group According to Weekly E-mails
|
62.8 percentage of exercises completed
Standard Deviation 37.8
|
—
|
SECONDARY outcome
Timeframe: 1 yearMeasured by the Cobb angle on radiograph
Outcome measures
| Measure |
Physical Therapy Exercise Group
n=35 Participants
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
n=22 Participants
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
|---|---|---|
|
Curve Magnitude
|
16.1 degrees
Standard Deviation 7.1
|
18.1 degrees
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: after 1 yearPopulation: Out of the 35 participants in the Exercise group who completed the study and 22 participants in the Control group who completed the study, 34 participants in the Exercise group and 21 participants in the Control group had curve magnitude data to report curve progression, since 1 patient in each group did not receive radiographic measurements at that timepoint.
Percentage of participants whose curve progressed \>5 degrees
Outcome measures
| Measure |
Physical Therapy Exercise Group
n=34 Participants
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
n=21 Participants
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
|---|---|---|
|
Curve Progression
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: after 1 yearMeasured by the percentage of participants prescribed a brace
Outcome measures
| Measure |
Physical Therapy Exercise Group
n=35 Participants
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
Scoliosis Specific Exercises
|
Control Group
n=22 Participants
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
|
|---|---|---|
|
Brace Prescription
|
9 Participants
|
12 Participants
|
Adverse Events
Physical Therapy Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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