Functional Electrical Stimulation Therapy After Stroke

Stroke Clinical Trial

Official title:

Efficacy and Feasibility of Using the NeuroLife Sleeve System to Improve Hand Function in Stroke Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06207240
• Other study ID #: 0828-RD0001.22
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: June 8, 2022

Study information

• Verified date: January 2024
• Source: Battelle Memorial Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Battelle has developed the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices, wearable sleeves that deliver non-invasive functional electrical stimulation (FES) paired with user intention. Participants in this study will use these devices while practicing functional tasks for about one hour at each session. FES will be applied through the forearm sleeve devices to assist with hand movements and grasps required by functional tasks simulating everyday activities such as turning a key or picking up a phone.

Sessions will be scheduled three days per week for 8 weeks total. Participants will complete clinical assessments at the beginning, midpoint and end of intervention as well as at follow-up sessions 2- and 10-weeks after the end of intervention to track upper limb function and impairment. Each session will last 1.5-2 hours, and participants will be compensated for their time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 8, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Battelle Memorial Institute	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Battelle Memorial Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Fugl-Meyer Assessment-Upper Extremity (UEFM)	The Fugl-Meyer Assessment-Upper Extremity (UEFM) subscore will be used to track impairment changes from the pre-intervention baseline. The UEFM is a common measure of upper extremity impairment after stroke ranging from 0 (maximal impairment) to 66 (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)
Secondary	Box and Block Test (BBT)	The Box and Block Test (BBT) will be used to track dexterity changes from the pre-intervention baseline. The BBT is a common measure of unilateral gross manual dexterity after stroke quantified by the number of blocks transferred between boxes within 60 seconds.	Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Secondary	Nine-Hole Peg Test (NHPT)	The Nine-Hole Peg Test (NHPT) will be used to track dexterity changes from the pre-intervention baseline. The NHPT is a common measure of unilateral manual dexterity after stroke quantified by the time taken to transfer nine pegs from holes to a dish.	Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Secondary	Motor Activity Log	The Motor Activity Log (MAL) will be used to track participants' use of their impaired arm throughout the study. The MAL is widely used to assess how stroke survivors use their more-impaired arm outside the laboratory through semi-structured interviews capturing the amount of use and quality of movement using their arm.	Week 0-8 (during the intervention period)