Trial Outcomes & Findings for Therapies for Recovery of Hand Function After Stroke (NCT NCT03574623)
NCT ID: NCT03574623
Last Updated: 2026-03-20
Results Overview
The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.
COMPLETED
NA
132 participants
Baseline to 6 months post-treatment
2026-03-20
Participant Flow
Participant milestones
| Measure |
CCFES
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Therapy
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
46
|
|
Overall Study
COMPLETED
|
36
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapies for Recovery of Hand Function After Stroke
Baseline characteristics by cohort
| Measure |
CCFES
n=36 Participants
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
n=39 Participants
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Training
n=38 Participants
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 10.9 • n=154 Participants
|
58.9 years
STANDARD_DEVIATION 13.7 • n=151 Participants
|
60.6 years
STANDARD_DEVIATION 12.5 • n=305 Participants
|
59.4 years
STANDARD_DEVIATION 12.4 • n=104 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=154 Participants
|
17 Participants
n=151 Participants
|
9 Participants
n=305 Participants
|
39 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=154 Participants
|
22 Participants
n=151 Participants
|
29 Participants
n=305 Participants
|
74 Participants
n=104 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=154 Participants
|
8 Participants
n=151 Participants
|
9 Participants
n=305 Participants
|
22 Participants
n=104 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=154 Participants
|
24 Participants
n=151 Participants
|
23 Participants
n=305 Participants
|
70 Participants
n=104 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=154 Participants
|
2 Participants
n=151 Participants
|
3 Participants
n=305 Participants
|
11 Participants
n=104 Participants
|
|
Race/Ethnicity, Customized
Unknown or Chose Not To Answer
|
2 Participants
n=154 Participants
|
2 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
4 Participants
n=104 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
0 Participants
n=154 Participants
|
2 Participants
n=151 Participants
|
3 Participants
n=305 Participants
|
5 Participants
n=104 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
1 Participants
n=104 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=154 Participants
|
39 participants
n=151 Participants
|
38 participants
n=305 Participants
|
113 participants
n=104 Participants
|
|
Time Since Stroke
|
12.4 months
STANDARD_DEVIATION 5.3 • n=154 Participants
|
13.5 months
STANDARD_DEVIATION 5.1 • n=151 Participants
|
13.5 months
STANDARD_DEVIATION 5.5 • n=305 Participants
|
13.1 months
STANDARD_DEVIATION 5.3 • n=104 Participants
|
|
Hand Weakness
Moderate
|
18 Participants
n=154 Participants
|
21 Participants
n=151 Participants
|
19 Participants
n=305 Participants
|
58 Participants
n=104 Participants
|
|
Hand Weakness
Severe
|
18 Participants
n=154 Participants
|
18 Participants
n=151 Participants
|
19 Participants
n=305 Participants
|
55 Participants
n=104 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-treatmentThe BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.
Outcome measures
| Measure |
CCFES
n=36 Participants
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
n=39 Participants
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Training
n=38 Participants
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
|---|---|---|---|
|
Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment
|
5.1 blocks
Interval 3.4 to 6.7
|
4.2 blocks
Interval 2.6 to 5.8
|
3.0 blocks
Interval 1.4 to 4.6
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentThe UEFM is a measure of upper limb motor impairment with a minimum score of 0 and maximum score of 66. The higher the score, the better the motor recovery.
Outcome measures
| Measure |
CCFES
n=36 Participants
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
n=39 Participants
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Training
n=38 Participants
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
|---|---|---|---|
|
Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment
|
8.1 units on a scale
Interval 6.1 to 10.1
|
3.7 units on a scale
Interval 1.6 to 5.7
|
4.4 units on a scale
Interval 2.4 to 6.4
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentThe ARAT is a measure of arm and hand function with a minimum score of 0 and maximum score of 57. The higher the score, the better the motor recovery.
Outcome measures
| Measure |
CCFES
n=36 Participants
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
n=39 Participants
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Training
n=38 Participants
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
|---|---|---|---|
|
Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment
|
5.8 units on a scale
Interval 3.6 to 7.9
|
4.8 units on a scale
Interval 2.7 to 7.0
|
1.7 units on a scale
Interval -0.4 to 3.8
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentThe SULCS is a measure of upper limb capacity with a minimum score of 0 and maximum score of 10. The higher the score, the better the motor recovery.
Outcome measures
| Measure |
CCFES
n=36 Participants
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
n=39 Participants
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Training
n=38 Participants
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
|---|---|---|---|
|
Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment
|
1.2 units on a scale
Interval 0.7 to 1.7
|
0.8 units on a scale
Interval 0.3 to 1.3
|
1.0 units on a scale
Interval 0.5 to 1.5
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentPopulation: The population analyzed for responder rate included only those participants who completed the 6 months post-treatment visit. There were 3, 8, and 4 participants from the CCFES, cNMES, and TOT group, respectively, who did not complete the 6 months post-treatment visit.
Proportion of participants who had a gain of at least 6 points on the UEFM
Outcome measures
| Measure |
CCFES
n=33 Participants
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
n=31 Participants
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Training
n=34 Participants
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
|---|---|---|---|
|
Responder Rate
|
22 Participants
|
13 Participants
|
13 Participants
|
Adverse Events
CCFES
cNMES
Task Oriented Training
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CCFES
n=44 participants at risk
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
cNMES
n=42 participants at risk
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Electrical Stimulator: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
Task Oriented Training
n=46 participants at risk
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Occupational Therapy: Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Upper extremity pain possibly due to study-related increased use or overuse
|
6.8%
3/44 • Number of events 5 • Enrollment to 6 months post-treatment
|
11.9%
5/42 • Number of events 7 • Enrollment to 6 months post-treatment
|
0.00%
0/46 • Enrollment to 6 months post-treatment
|
|
Investigations
Transient discomfort from electrical stimulation
|
2.3%
1/44 • Number of events 1 • Enrollment to 6 months post-treatment
|
4.8%
2/42 • Number of events 3 • Enrollment to 6 months post-treatment
|
0.00%
0/46 • Enrollment to 6 months post-treatment
|
|
Investigations
Skin burn from stimulation
|
2.3%
1/44 • Number of events 1 • Enrollment to 6 months post-treatment
|
0.00%
0/42 • Enrollment to 6 months post-treatment
|
0.00%
0/46 • Enrollment to 6 months post-treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place