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A Potential Wearable for Post-stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154514
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : July 15, 2020
Sponsor:
Collaborators:
The Hong Kong Polytechnic University
City University of Hong Kong
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Cheung Chi Kwan Vincent, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Chronic Stroke Device: A functional electrical stimulation device for post-stroke rehabilitation Not Applicable

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 10-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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Wearable for Post-stroke Rehabilitative Multi-muscle Stimulation Inspired by the Natural Organization of Neuromuscular Control
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 23, 2023
Estimated Study Completion Date : June 23, 2023

Resource links provided by the National Library of Medicine


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 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Fugl-Meyer assessment score (lower-limb) [ Time Frame: The assessment will be performed at baseline ]
    Lower-limb motor function assessment

  6. Fugl-Meyer assessment score (lower-limb) [ Time Frame: The assessment will be performed at 5.5 weeks ]
    Lower-limb motor function assessment

  7. Fugl-Meyer assessment score (lower-limb) [ Time Frame: The assessment will be performed at 2.5 weeks ]
    Lower-limb motor function assessment

  8. Fugl-Meyer assessment score (lower-limb) [ Time Frame: The assessment will be performed at 4 weeks ]
    Lower-limb motor function assessment

  9. Mini-BEStest [ Time Frame: The assessment will be performed at baseline ]
    Balance test

  10. Mini-BEStest [ Time Frame: The assessment will be performed at 5.5 weeks ]
    Balance test

  11. Mini-BEStest [ Time Frame: The assessment will be performed at 2.5 weeks ]
    Balance test

  12. Mini-BEStest [ Time Frame: The assessment will be performed at 4 weeks ]
    Balance test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154514


Contacts
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Contact: Vincent Chi Kwan Cheung, PhD +852 3943 9389 vckc@cuhk.edu.hk
Contact: Roy Tsz Hei Cheung, PhD +852 2766 6739 roy.cheung@polyu.edu.hk

Sponsors and Collaborators
Chinese University of Hong Kong
The Hong Kong Polytechnic University
City University of Hong Kong
Shanghai Jiao Tong University School of Medicine
Publications:
Bernstein N (1967) The co-ordination and regulation of movements. Oxf. PergamoPress.
Brunnström S (1970) Movement therapy in hemiplegia: a neurophysiological approach. Medical Dept., Harper & Row.
Zhuang C, Marquez J, Qu H, He X, Lan N (2015) A neuromuscular electrical stimulation strategy based on muscle synergy for stroke rehabilitation. 2015:816-819.
Niu C (2018) Effectiveness of Short-Term Training with a Synergy-Based FES Paradigm on Motor Function Recovery Post Stroke, in 12th International Society of Physical and Rehabilitation Medicine World Congress (Paris, France).
Cerina L, Cancian P, Franco G, Santambrogio M (2017) A hardware acceleration for surface EMG non-negative matrix factorization. IEEE Int Parallel & Distributed Processing Symposium Workshops 2017: 168-74.

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Responsible Party: Cheung Chi Kwan Vincent, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04154514    
Other Study ID Numbers: CREC_RIF_PROTOCOL version 01
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases