Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
53 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-02-01
Study Completion Date
2025-12-01
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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Chronic Stroke
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
A functional electrical stimulation device for post-stroke rehabilitation
Intervention Type
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.
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.
Group Type
EXPERIMENTAL
A functional electrical stimulation device for post-stroke rehabilitation
Intervention Type
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.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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
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
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
Minimum Eligible Age
40 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Sponsor Role
collaborator
City University of Hong Kong
OTHER
Sponsor Role
collaborator
Shanghai Jiao Tong University School of Medicine
OTHER
Sponsor Role
collaborator
Chinese University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Cheung Chi Kwan Vincent
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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The Hong Kong Polytechnic University
Hong Kong, Hong Kong, Hong Kong
Site Status
Countries
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Hong Kong
References
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Other Identifiers
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CREC_RIF_PROTOCOL version 01
Identifier Type: -
Identifier Source: org_study_id