EMG Controlled Device in Acute Rehabilitation After Acute Stroke

NCT04599036 | Active Not Recruiting DMC FDA Device

• 1 other identifier: B3554-M
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a medically relevant problem for the aging population. Individuals with stroke experience a high amount of arm functional deficits despite receiving rehabilitation. Functional deficits can be improved by combining rehabilitation with innovative rehabilitative tools that target the brain mechanisms that guide the recovery early after stroke. This study aims to explore the feasibility of implementing an EMG controlled device in the acute rehabilitation for stroke survivors with severe arm deficit. This study will determine if adding such a technology improve the clinical outcomes for subjects with severe arm impairments beyond the levels achieved by standard care in attempt to increase their chances to independently perform activities of daily living.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Changes in arm impairment using Fugl-Meyer assessment (FMA)

  Measure of arm impairment. Scores on the FMA may range from 0-66 points, with higher score indicating better performance.

  Change from Baseline arm impairment after 6 weeks

Secondary Outcomes (1)

• Changes in arm function using Action Research Arm Test (ARAT)

  Change from Baseline arm function after 6 weeks

Study Arms (1)

Feasibility

EXPERIMENTAL

To explore if the feasibility of adding an EMG controlled device to the acute rehabilitation for stroke subjects with severe arm deficit.

Device: MARK

Interventions

MARK DEVICE

EMG controlled arm orthosis

Feasibility

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans over 18 years of age
• days to 6 months since the onset of ischemic stroke
• Adequate range of motion at the elbow, forearm, wrist, and hand to wear the device.
• Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the Myopro software
• MAS score 3 for the biceps, triceps, supinators and pronators of the impaired arm
• Able to read and comprehend the English language
• Able to follow directions
• Medically and psychologically stable.
• Healthy Controls:
• Over 18 years of age No history of neurological or muscular problems that affect arm function

You may not qualify if:

• Hemorrhagic stroke
• Previous strokes affecting motor function on the opposite side.
• Fugl-Meyer score of 2 on the following 3 items:
• \) finger mass extension, 2) grasp #1 test, and 3) shoulder flexion 90 - 180 degrees, elbow at 0 degree, and forearm neutral.
• Shoulder subluxation, pain or dislocation
• Shoulder passive range of motion \< 45 degrees in flexion and abduction
• Fixed upper limb contractures on the impaired arm and hand
• Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
• Skin rash or open wound on impaired arm
• Involuntary movements of the impaired arm
• Pacemaker or other implanted devices
• Metal in the skull
• Claustrophobia, or inability to operate the MRI patient call button
• Past history of seizures
• Family history of medication refractory epilepsy

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ahlam Salameh, PhD MSc

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: October 7, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)