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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

132 participants

Primary outcome timeframe

Baseline to 6 months post-treatment

Results posted on

2026-03-20

Participant Flow

Participant milestones

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

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-treatment

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.

Outcome measures

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-treatment

The 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

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-treatment

The 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

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-treatment

The 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

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-treatment

Population: 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

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

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

cNMES

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Task Oriented Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. Jayme Knutson

The MetroHealth System

Phone: 216-957-3557

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place