Trial Outcomes & Findings for Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke (NCT NCT03058796)

NCT ID: NCT03058796

Last Updated: 2024-01-05

Results Overview

The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: 0 weeks,12 weeks, 36 weeks
• Results posted on: 2024-01-05

Participant Flow

Participant milestones

Measure	CCFES Video Game Therapy Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.	CCFES Therapy Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.
Overall Study STARTED	27	25
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke

Baseline characteristics by cohort

Measure	CCFES Video Game Therapy n=27 Participants Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.	CCFES Therapy n=25 Participants Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.	Total n=52 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=5 Participants	62 years STANDARD_DEVIATION 11 • n=7 Participants	61 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Years Since Stroke	5 years STANDARD_DEVIATION 4.5 • n=5 Participants	3.9 years STANDARD_DEVIATION 3.4 • n=7 Participants	4.5 years STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: 0 weeks,12 weeks, 36 weeks

The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.

Outcome measures

Measure	CCFES Video Game Therapy n=18 Participants Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.	CCFES Therapy n=21 Participants Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.
Box and Block Test Score 0 weeks	10.6 blocks Standard Error 2.6	11.0 blocks Standard Error 2.6
Box and Block Test Score 12 weeks	11.2 blocks Standard Error 2.8	12.4 blocks Standard Error 2.8
Box and Block Test Score 36 weeks	11.1 blocks Standard Error 2.7	11.6 blocks Standard Error 2.6

SECONDARY outcome

Timeframe: 0 weeks, 12 weeks, 36 weeks

The ARAT is an activity limitation measure that assesses a subject's ability to handle objects differing in size, weight and shape. Min value = 0 (least functional), Max value = 57 (most functional)

Outcome measures

Measure	CCFES Video Game Therapy n=18 Participants Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.	CCFES Therapy n=21 Participants Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.
Action Research Arm Test (ARAT) Score 0 weeks	19.4 units on a scale Standard Error 3.6	19.0 units on a scale Standard Error 2.6
Action Research Arm Test (ARAT) Score 12 weeks	18.6 units on a scale Standard Error 3.5	21.2 units on a scale Standard Error 2.8
Action Research Arm Test (ARAT) Score 36 weeks	18.8 units on a scale Standard Error 3.7	20.6 units on a scale Standard Error 2.8

Adverse Events

CCFES Video Game Therapy

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

CCFES Therapy

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	CCFES Video Game Therapy n=27 participants at risk Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.	CCFES Therapy n=25 participants at risk Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.
Nervous system disorders Fall leading to hospitalization	7.4% 2/27 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.	4.0% 1/25 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.
Musculoskeletal and connective tissue disorders Car Accident leading to hospitalization	3.7% 1/27 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.	0.00% 0/25 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.
Respiratory, thoracic and mediastinal disorders Infection leading to hospitalization	0.00% 0/27 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.	4.0% 1/25 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.

Other adverse events

Measure	CCFES Video Game Therapy n=27 participants at risk Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.	CCFES Therapy n=25 participants at risk Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks.
Nervous system disorders Fall not leading to hospitalization	29.6% 8/27 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.	28.0% 7/25 • Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.

Additional Information

Dr. Jayme Knutson

The MetroHealth System

Phone: 216-957-3557

Email: jsk12@case.edu

Results disclosure agreements

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