Treadmill With Biofeedback on Gait Symmetry After Stroke

Sponsor

National Yang Ming University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04441541

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke Syndrome	Other: Treadmill with auditory feedback Other: Treadmill with visual feedback Other: Treadmill with auditory and visual feedback Other: Treadmill training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Treadmill With Biofeedback on Gait Symmetry in Individuals With Chronic Stroke

Anticipated Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treadmill with auditory feedback group	Other: Treadmill with auditory feedback Participants will receive training 3 times per week for 4 weeks (12 sessions).
Experimental: Treadmill with visual feedback group	Other: Treadmill with visual feedback Participants will receive training 3 times per week for 4 weeks (12 sessions).
Experimental: Treadmill with auditory and visual feedback group	Other: Treadmill with auditory and visual feedback Participants will receive training 3 times per week for 4 weeks (12 sessions).
Active Comparator: Treadmill training group	Other: Treadmill training Participants will receive training 3 times per week for 4 weeks (12 sessions).

Outcome Measures

Primary Outcome Measures

Spatial and temporal gait symmetry [Change from baseline at the first day, 4 weeks, and 8 weeks]
Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)

Secondary Outcome Measures

Walking speed [Change from baseline at the first day, 4 weeks, and 8 weeks]
6 Minute Walk Test [Change from baseline at the first day, 4 weeks, and 8 weeks]
Timed up and Go test [Change from baseline at the first day, 4 weeks, and 8 weeks]
Stroke Impact Scale [Change from baseline at the first day, 4 weeks, and 8 weeks]
quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Single stroke experience
Chronic stroke phase: stroke duration ≥ 6 months
Independent gait: Functional Ambulation Category (FAC) ≥ 3

Exclusion Criteria:

Cognitive problem (MMSE < 24)
Visual or audio deficiency that might affect training
Severe heart insufficiency or uncontrolled arterial hypertension
Orthopedic disorders that affecting their gait

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yea-Ru Yang, Professor, National Yang Ming University

ClinicalTrials.gov Identifier:

NCT04441541

Other Study ID Numbers:

YM109073F

First Posted:

Jun 22, 2020

Last Update Posted:

Jun 22, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yea-Ru Yang, Professor, National Yang Ming University

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 22, 2020