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HealthyNCT04155866

Comparing the Difference in Muscle Synergies Between Healthy Participants and Chronic Stroke Survivors

An observational study of Healthy, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Measurement of muscle activation.
How many people
30 participants
Where
1 siteHong Kong
Study dates
1 Jul 2021to 1 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Age-matched healthy control subjects will be recruited through advertisements. Chronic Stroke Survivors will be recruited from the local community such as clinic.

Who may be able to join

  • For chronic stroke survivors:
  • 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
  • For healthy participants:
  • Healthy, right-handed subjects, age ≥40, free from any history of major neurological, musculoskeletal, and psychiatric disorders
  • Able to walk continuously for ≥20 min. without fatigue.

Who cannot join

  • For both healthy participants and chronic stroke survivors:
  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • The Hong Kong Polytechnic University

    Hong Kong, Hong Kong, 852

Other trials in Hong Kong

About this study

Official title: 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. Patricipants 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. Before applying FES stimulations to chronic stroke survivors, participants will have to define normal muscle synergies from age-matched healthy control participants (1 session for each participant). After comparing the difference in muscle synergies in both healthy subjects and chronic stroke survivors, participants are attempting to rehabilitate the gait of chronic stroke survivors by using the wearable. Each chronic stroke survivor will undergo 18-session FES training (~ 1 month).

It is hypothesized that FES will promote motor recovery by supplying the missing normal muscle synergies to chronic stroke survivors at their supposed times of activations in each step cycle during interventional training. 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. The healthy normal muscle synergies will be defined by EMG recordings from the recruited healthy participants.

Read the 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 stimulation 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 aim of our project is to rehabilitate the gait of chronic stroke survivors by delivering stimulations to multiple muscles, in their natural coordination pattern, using our wearable. 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 - identified from age-matched healthy subjects - 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 a restoration of normal neuromuscular coordination, thus more natural post-training gait.

Conditions
Healthy
Being tested
Measurement of muscle activation.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measurement of muscle activation.Other

    Measurement of lower-limb muscle activation during walking for healthy participants.

Study groups in NCT04155866
Study groupRoleWhat they receive
Healthy participantsMeasurement of lower-limb muscle activation from healthy participants.
Receives: Other: Measurement of muscle activation.
Chronic Stroke SurvivorsMeasurement of lower-limb muscle activation from chronic stroke survivors
Receives: Other: Measurement of muscle activation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surface electromyographic signals from up to 14 muscles on each side of healthy participants 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.

    Measured: The assessment will be performed at 1 week

  2. 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.

    Measured: The assessment will be performed at baseline

  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.

    Measured: The assessment will be performed at 5.5 weeks

  4. 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.

    Measured: The assessment will be performed at 2.5 weeks

  5. 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.

    Measured: The assessment will be performed at 4 weeks

Secondary outcomes (13)
  1. Measuring Gait kinematics from Healthy Participants

    Kinematic measurements will be provided by the wearable's IMUs. During 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.

    Measured: The assessment will be performed at 1 week

  2. Measuring Gait kinematics from Chronic Stroke Survivors

    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.

    Measured: The assessment will be performed at baseline

  3. Measuring Gait kinematics from Chronic Stroke Survivors

    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.

    Measured: The assessment will be performed at 5.5 weeks

  4. Measuring Gait kinematics from Chronic Stroke Survivors

    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.

    Measured: The assessment will be performed at 2.5 weeks

  5. Measuring Gait kinematics from Chronic Stroke Survivors

    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.

    Measured: The assessment will be performed at 4 weeks

  6. Fugl-Meyer assessment score (lower-limb)

    Lower-limb motor function assessment

    Measured: The assessment will be performed at baseline

  7. Fugl-Meyer assessment score (lower-limb)

    Lower-limb motor function assessment

    Measured: The assessment will be performed at 5.5 weeks

  8. Fugl-Meyer assessment score (lower-limb)

    Lower-limb motor function assessment

    Measured: The assessment will be performed at 2.5 weeks

  9. Fugl-Meyer assessment score (lower-limb)

    Lower-limb motor function assessment

    Measured: The assessment will be performed at 4 weeks

  10. Mini-BEStest

    Balance test

    Measured: The assessment will be performed at baseline

  11. Mini-BEStest

    Balance test

    Measured: The assessment will be performed at 5.5 weeks

  12. Mini-BEStest

    Balance test

    Measured: The assessment will be performed at 2.5 weeks

  13. Mini-BEStest

    Balance test

    Measured: The assessment will be performed at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start1 Jul 2021
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04155866
Sponsor's protocol ID
RIF_Healthy_version 01
Status last verified
Dec 2025
First submitted
10 Oct 2019
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Krasovsky T, Levin MF. Review: toward a better understanding of coordination in healthy and poststroke gait. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):213-24. doi: 10.1177/1545968309348509. Epub 2009 Oct 12.

    PubMed 19822722
  • Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103.

    PubMed 16004574
  • Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.

    PubMed 17299744
  • Heller BW, Clarke AJ, Good TR, Healey TJ, Nair S, Pratt EJ, Reeves ML, van der Meulen JM, Barker AT. Automated setup of functional electrical stimulation for drop foot using a novel 64 channel prototype stimulator and electrode array: results from a gait-lab based study. Med Eng Phys. 2013 Jan;35(1):74-81. doi: 10.1016/j.medengphy.2012.03.012. Epub 2012 May 4.

    PubMed 22559959
  • Springer S, Vatine JJ, Wolf A, Laufer Y. The effects of dual-channel functional electrical stimulation on stance phase sagittal kinematics in patients with hemiparesis. J Electromyogr Kinesiol. 2013 Apr;23(2):476-82. doi: 10.1016/j.jelekin.2012.10.017. Epub 2012 Dec 8.

    PubMed 23231828
  • You G, Liang H, Yan T. Functional electrical stimulation early after stroke improves lower limb motor function and ability in activities of daily living. NeuroRehabilitation. 2014;35(3):381-9. doi: 10.3233/NRE-141129.

    PubMed 25227538
  • 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.

  • Ferrante S, Chia Bejarano N, Ambrosini E, Nardone A, Turcato AM, Monticone M, Ferrigno G, Pedrocchi A. A Personalized Multi-Channel FES Controller Based on Muscle Synergies to Support Gait Rehabilitation after Stroke. Front Neurosci. 2016 Sep 16;10:425. doi: 10.3389/fnins.2016.00425. eCollection 2016.

    PubMed 27695397
  • Barroso FO, Torricelli D, Molina-Rueda F, Alguacil-Diego IM, Cano-de-la-Cuerda R, Santos C, Moreno JC, Miangolarra-Page JC, Pons JL. Combining muscle synergies and biomechanical analysis to assess gait in stroke patients. J Biomech. 2017 Oct 3;63:98-103. doi: 10.1016/j.jbiomech.2017.08.006. Epub 2017 Aug 20.

    PubMed 28882330

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surface electromyographic signals from up to 14 muscles on each side of healthy participants during gait. (time frame: The assessment will be performed at 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155866, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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