GAM: EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05628324

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 3 times a week for 6 weeks to receive upper limb task practice and/or muscle activity training. Participants will also come to the laboratory for additional 3 visits for assessments of upper extremity function. The total duration of the study will be 2.5 months.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: practice muscle activation patterns Behavioral: task practice	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2-arm randomized controlled trial2-arm randomized controlled trial

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2027

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMG + task training Train with EMG-controlled games and functional task practice	Behavioral: practice muscle activation patterns practice upper limb muscle activation patterns using EMG-controlled games Behavioral: task practice practice functional upper limb tasks
Active Comparator: task training Train with functional task practice for a total of 18 sessions	Behavioral: task practice practice functional upper limb tasks

Arm

Intervention/Treatment

Experimental: EMG + task training

Train with EMG-controlled games and functional task practice

Behavioral: practice muscle activation patterns

practice upper limb muscle activation patterns using EMG-controlled games

Behavioral: task practice

practice functional upper limb tasks

Active Comparator: task training

Train with functional task practice for a total of 18 sessions

Behavioral: task practice

practice functional upper limb tasks

Outcome Measures

Primary Outcome Measures

Wolf Motor Function Test [within 1 week from intervention completion]
Functional abilities scale for completing upper limb tasks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18+ years old
Stroke more than 6 months ago
Moderate upper limb impairment
Cognitive ability to participate in the study procedure
Ability to see the full computer screen

Exclusion Criteria:

Concurrent upper limb rehabilitation
Severe spasticity prohibiting voluntary muscle contraction to participate in training
Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
Total sensory loss
Comorbidity (e.g., orthopaedic or premorbid neurologic condition) that limit upper limb movement and/or participation in the intervention
Language barrier or cognitive impairment that precludes providing consent