A Potential Wearable for Post-stroke Rehabilitation

NCT04154514 | Completed

• 1 other identifier: CREC_RIF_PROTOCOL version 01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Participants are seeking to unleash the full therapeutic potential of a newly developed, customizable and potentially commericializable 10-channel Functional Electrical Stimulation (FES) to rehabilitate the gait of chronic stroke survivors. Each subject will undergo 18-sessions (\~1 month) FES training. Participants will utilize the theory of muscle synergies from motor neurosciences, which are defined as neural modules of motor control that coordinate the spatiotemporal activation patterns of multiple muscles, to guide our personal selections of muscles for FES. It is hypothesized that chronic stroke survivors will learn from FES stimulations, over several daily sessions, both by suppressing the original abnormal muscle synergies and by employing the normal muscle synergies as specified in the FES. It is also expected that the walk synergies of the paretic side of chronic stroke survivors should be more similar to healthy muscle synergies at the two post-training time points than before training.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (3)

• Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at baseline

• Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at 5.5 weeks

• Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at 2.5 weeks

Secondary Outcomes (12)

• Gait kinemetics

  The assessment will be performed at baseline

• Gait kinemetics

  The assessment will be performed at 5.5 weeks

• Gait kinemetics

  The assessment will be performed at 2.5 weeks

• Gait kinemetics

  The assessment will be performed at 4 weeks

• Fugl-Meyer assessment score (lower-limb)

  The assessment will be performed at baseline

Study Arms (2)

Delivering FES to stroke survivors

EXPERIMENTAL

In stroke survivors, normal and abnormal muscle synergies will also be determined from their walk EMGs. Our proposed FES intervention involves delivering stimulations to muscles with waveforms generated from the activations of all the normal synergies not observed in each stroke survivor. We are going to employ the wearable to deliver personalized muscle-synergy-based FES stimulations to multiple groups of leg muscles on the stroke-affected side of elderly chronic stroke survivors as they walk on a treadmill/overground for gait rehabilitation. We hypothesized that the subject will essentially be walking with his/her abnormal muscle pattern superimposed with the artificially introduced "normal" muscle pattern coming from FES.

Device: A functional electrical stimulation device for post-stroke rehabilitation

Delivery no current FES to stroke survivors (Sham group)

EXPERIMENTAL

In stroke survivors, normal and abnormal muscle synergies will also be determined from their walk EMGs. Our proposed FES intervention involves delivering stimulations to muscles with waveforms generated from the activations of all the normal synergies not observed in each stroke survivor. Additionally, we are going to introduce a sham group. We are going to employ the wearable to multiple groups of leg muscles on the stroke-affected side of elderly chronic stroke survivors without any stimulation as they walk on a treadmill or overground for gait rehabilitation. The purpose of the sham group is to empirically validate the effectiveness of the FES wearable.

Device: A functional electrical stimulation device for post-stroke rehabilitation

Interventions

A functional electrical stimulation device for post-stroke rehabilitation DEVICE

Most of the FDA-approved commercial FES devices deliver therapy that targets specific kinematic impairment in the step cycle (e.g., foot drop). Our device will be unique in that it can stimulate many muscles around multiple joints for a more comprehensive and naturalistic restoration of lower-limb motor functions.

Delivering FES to stroke survivors; Delivery no current FES to stroke survivors (Sham group)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right-handed elderly chronic stroke survivors; age ≥40; ≥6 months post-stroke
• Unilateral ischemic brain lesions
• Participants should be able to walk continuously for ≥15 min. with or without assistive aid

You may not qualify if:

• Cannot comprehend and follow instructions, or with a score \<21 on the mini-mental state exam;
• Have cardiac pacemaker;
• Have skin lesions at the locations where FES or EMG electrodes may be attached;
• Have major depression;
• Present with severe neglect
• Patients with type i and ii diabetes

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator
• City University of Hong Kong: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 852, Hong Kong

Location

Related Publications (61)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: November 6, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

HK (1)