Functional Electrical Stimulation Therapy After Stroke

NCT06207240 | Completed FDA Device

• 1 other identifier: 0828-RD0001.22
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility study is to test the feasibility of providing task-oriented, intention-driven functional electrical stimulation (FES) using the novel NeuroLife FES Sleeve and NeuroLife electromyography (EMG) and FES Sleeve devices in chronic stroke survivors. The main questions it aims to answer are:

• Can these devices be used to administer task-oriented therapy with assistive stimulation at similar doses to current standards of care?
• How does therapy using these devices impact the upper limb function in a few chronic stroke survivors? Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks.

Conditions

Stroke

Keywords

stroke rehabilitation, functional electrical stimulation

Outcome Measures

Primary Outcomes (2)

• Action Research Arm Test (ARAT)

  The Action Research Arm Test (ARAT) will be used to track functional changes from the pre-intervention baseline. The ARAT is a common measure of upper extremity function after stroke ranging from 0 (maximal impairment) to 57 (no impairment).

  Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)

• Therapy Dose

  Therapy Dose was used to estimate the feasibility of the therapy. Therapy Dose will be computed as the average amount of time at each session the subject was engaged in intention-driven, task-oriented functional electrical stimulation therapy, excluding the time needed to set up the system.

  Week 0-18 (during the intervention and follow-up periods)

Secondary Outcomes (4)

• Fugl-Meyer Assessment-Upper Extremity (UEFM)

  Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)

• Box and Block Test (BBT)

  Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)

• Nine-Hole Peg Test (NHPT)

  Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)

• Motor Activity Log

  Week 0-8 (during the intervention period)

Study Arms (1)

FES Therapy

EXPERIMENTAL

Intention-driven assistive functional electrical stimulation provided during approximately 1 hour of task-oriented therapy. Sessions will be scheduled 3 days per week for 8 weeks.

Device: NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve

Interventions

NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve DEVICE

Electrical stimulation will be delivered via the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices to assist with movement during functional task practice.

Also known as: Functional Electrical Stimulation Therapy (FEST)

FES Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years old
• Diagnosis of stroke
• Ability to provide appropriate consent to partake in the study
• Ability to follow 3-step commands and deemed by an occupational therapist to have the capacity to complete required upper extremity movements
• Ability to secure transportation to attend scheduled study sessions
• Stroke-related hand impairment that interferes with ability to complete activities of daily living and is classified as Stage 1-6 on the hand subscale of the Chedoke McMaster Stroke Assessment

You may not qualify if:

• Presence of any other clinically significant medical comorbidity for which, in the judgment of the Investigator, participation in the study would pose a safety risk to the subject
• Currently participating in physical rehabilitation (e.g., occupational or physical therapy) for stroke-related upper limb impairment
• Co-occurring neurological condition (e.g., Parkinson's disease, Multiple Sclerosis) or other neuromuscular disorder (e.g., Carpal Tunnel Syndrome, neuropathy) that, in the judgment of the Investigator, may influence study results
• Individuals who are immunosuppressed, have conditions that typically result in becoming immunocompromised, taking chronic steroids, or currently receiving immunosuppressive therapy
• Individuals having or requiring any of the following: implanted pacemaker, life supporting/sustaining equipment, or critical non-removable implantable electronic devices such as an insulin pump.
• Persistent pain ≥ 7/10 in impaired upper extremity, as measured by Visual Analogue Scale
• Individuals whose forearm is determined to be too small or too large to fit the electrode sleeve being investigated.
• Individuals who are pregnant or plan to get pregnant during the course of the study.

Sponsors & Collaborators

• Battelle Memorial Institute: lead

Study Sites (1)

Battelle Memorial Institute

Columbus, Ohio, 43201, 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

• Eric Meyers, PhD

  Principal Biomedical Engineer

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All participants will receive identical intervention protocols.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 16, 2024
• Study Start: January 18, 2022
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)