Neuromuscular Electrical Stimulation Cycling

NCT ID: NCT03208439

Last Updated: 2017-09-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EMG-driven NMES

subjects will receive EMG-driven NMES cycling exercise.

Group Type EXPERIMENTAL

lower-limb cycling system

Intervention Type DEVICE

patients will receive 30-minute cycling exercise

passive pre-programmed NMES

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

Group Type PLACEBO_COMPARATOR

lower-limb cycling system

Intervention Type DEVICE

patients will receive 30-minute cycling exercise

Interventions

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lower-limb cycling system

patients will receive 30-minute cycling exercise

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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;
2. severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
3. implanted cardiac device (e.g. pacemaker and internal defibrillator).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Kai-yu Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Engineering, CUHK

Locations

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Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Raymond Kai-yu Tong, PhD

Role: CONTACT

+852 3943 8454

Facility Contacts

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Raymond Tong, PhD

Role: primary

+852 3943 8454

References

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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.

Reference Type DERIVED
PMID: 34975713 (View on PubMed)

Other Identifiers

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2016.093-T

Identifier Type: -

Identifier Source: org_study_id