A Potential Wearable for Post-stroke Rehabilitation

May 21, 2023 updated by: Cheung Chi Kwan Vincent, Chinese University of Hong Kong

A Wearable for Post-stroke Rehabilitative Multi-muscle Stimulation Inspired by the Natural Organization of Neuromuscular Control

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is one of the leading causes of long-term adult disability worldwide. The impaired ability to walk post-stroke severely limits mobility and quality of life. Many recently-developed assistive technologies for gait rehabilitation are at present only marginally better at best than traditional therapies in their efficacies. There is an urgent need of novel, clinically viable, and effective gait rehabilitative strategies that can provide even better functional outcome for stroke survivors with diverse presentations.

Among the many new post-stroke interventions, functional electrical stimulation (FES) of muscles remains attractive. FES is a neural-rehabilitative technology that communicates control signals from an external device to the neuromuscular system. There is increasing recognition that rehabilitation paradigms should promote restitution of the patient's muscle coordination towards the normal pattern during training, and FES can achieve this goal when stimulations are applied to the set of muscles whose natural coordination is impaired. For this reason, FES is a very promising interventional strategy. Existing FES paradigms, however, have yielded ambiguous results in previous clinical trials, especially those for chronic survivors, likely because either stimulations were applied only to single or a few muscles, or the stimulation pattern did not mimic the natural muscle coordination pattern during gait. A multi-muscle FES, when applied to a larger functional set of muscles and driven by their natural coordination pattern, can guide muscle activations towards the normal pattern through neuroplasticity, thus restore impairment at the level of muscle-activation deficit.

The first aim of our project is to utilize a 8-channel FES wearable for delivering multi-muscle FES to muscles in the lower-limb muscles. Participants will attempt to rehabilitate the gait of chronic stroke survivors over 12 training sessions by delivering stimulations to multiple muscles, in their natural coordination pattern, using our wearable. As such, participants will utilize the theory of muscle synergy from motor neuroscience to guide our personalizable selections of muscles for FES. Muscle synergies are hypothesized neural modules of motor control that coordinate the spatiotemporal activation patterns of multiple muscles. Our customizable FES pattern for each stroke survivor will be constructed based on the normal muscle synergies that are absent in the stroke survivor's muscle pattern during walking. Since muscle synergies represent the natural motor-control units used by the nervous system, reinforcement of their activations through FES should lead to restoration of normal neuromuscular coordination, thus more natural post-training gait.

Our second aim is to evaluate the effectiveness of our FES paradigm by assessing the walk-muscle synergies in the paretic and non-paretic legs of the trained stroke survivors, before, after, and 1 month following our intervention. In doing so, participants hope to explore whether lower-limb muscle synergy can be a physiologically-based marker of motor impairment for stroke survivors.

If our muscle-synergy-based multi-muscle FES is indeed efficacious, our strategy will help many disabled chronic stroke survivors to regain mobility, thus living with a much higher quality of life in the decades to come. The clinical and societal impact of our research will be huge.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vincent Chi Kwan Cheung, PhD
  • Phone Number: +852 3943 9389
  • Email: vckc@cuhk.edu.hk

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delivering FES to stroke survivors
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
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.
Experimental: Delivery no current FES to stroke survivors (Sham group)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.
Time Frame: The assessment will be performed at baseline
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.
Time Frame: The assessment will be performed at 5.5 weeks
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.
Time Frame: The assessment will be performed at 2.5 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer assessment score (lower-limb)
Time Frame: The assessment will be performed at baseline
Lower-limb motor function assessment
The assessment will be performed at baseline
Fugl-Meyer assessment score (lower-limb)
Time Frame: The assessment will be performed at 5.5 weeks
Lower-limb motor function assessment
The assessment will be performed at 5.5 weeks
Fugl-Meyer assessment score (lower-limb)
Time Frame: The assessment will be performed at 2.5 weeks
Lower-limb motor function assessment
The assessment will be performed at 2.5 weeks
Fugl-Meyer assessment score (lower-limb)
Time Frame: The assessment will be performed at 4 weeks
Lower-limb motor function assessment
The assessment will be performed at 4 weeks
Mini-BEStest
Time Frame: The assessment will be performed at baseline
Balance test
The assessment will be performed at baseline
Mini-BEStest
Time Frame: The assessment will be performed at 5.5 weeks
Balance test
The assessment will be performed at 5.5 weeks
Mini-BEStest
Time Frame: The assessment will be performed at 2.5 weeks
Balance test
The assessment will be performed at 2.5 weeks
Mini-BEStest
Time Frame: The assessment will be performed at 4 weeks
Balance test
The assessment will be performed at 4 weeks
Gait kinemetics
Time Frame: The assessment will be performed at baseline
During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle.
The assessment will be performed at baseline
Gait kinemetics
Time Frame: The assessment will be performed at 5.5 weeks
During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle.
The assessment will be performed at 5.5 weeks
Gait kinemetics
Time Frame: The assessment will be performed at 2.5 weeks
During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle.
The assessment will be performed at 2.5 weeks
Gait kinemetics
Time Frame: The assessment will be performed at 4 weeks
During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle.
The assessment will be performed at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

The Hong Kong Polytechnic University
Shanghai Jiao Tong University School of Medicine
City University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

March 23, 2024

Study Completion (Anticipated)

June 23, 2024

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC_RIF_PROTOCOL version 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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