NCT03208439

Brief Summary

A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

July 3, 2017

Last Update Submit

September 15, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Lower-Extremities Fugl-Meyer Assessment

    3-month follow up

Secondary Outcomes (5)

  • Elderly Mobility Scale

    3-month follow up

  • Berg Balance Scale

    3-month follow up

  • 6-Minute Walking Test

    3-month follow up

  • 10-Meter Walk Test

    3-month follow up

  • electroencephalography

    3-month follow up

Study Arms (2)

EMG-driven NMES

EXPERIMENTAL

subjects will receive EMG-driven NMES cycling exercise.

Device: lower-limb cycling system

passive pre-programmed NMES

PLACEBO COMPARATOR

subjects will receive passive pre-programmed NMES during cycling exercise.

Device: lower-limb cycling system

Interventions

lower-limb cycling systemDEVICE

patients will receive 30-minute cycling exercise

EMG-driven NMESpassive pre-programmed NMES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
  • sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
  • significant gait deficit (Functional Ambulatory Category, FAC, scale \<4 \[person cannot walk independently\]).

You may not qualify if:

  • any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression;
  • severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
  • implanted cardiac device (e.g. pacemaker and internal defibrillator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Related Publications (1)

  • Hu C, Wang T, Leung KWC, Li L, Tong RK. Muscle Electrical Impedance Properties and Activation Alteration After Functional Electrical Stimulation-Assisted Cycling Training for Chronic Stroke Survivors: A Longitudinal Pilot Study. Front Neurol. 2021 Dec 15;12:746263. doi: 10.3389/fneur.2021.746263. eCollection 2021.

    PMID: 34975713DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Kai-yu Tong, PhD

    Department of Biomedical Engineering, CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Kai-yu Tong, PhD

CONTACT

+852 3943 8454kytong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 5, 2017

Study Start

August 10, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)