Treadmill With Biofeedback on Gait Symmetry After Stroke

June 18, 2020 updated by: Yea-Ru Yang, National Yang Ming University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial and temporal gait symmetry
Time Frame: 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)
Change from baseline at the first day, 4 weeks, and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: Change from baseline at the first day, 4 weeks, and 8 weeks
Change from baseline at the first day, 4 weeks, and 8 weeks
6 Minute Walk Test
Time Frame: Change from baseline at the first day, 4 weeks, and 8 weeks
Change from baseline at the first day, 4 weeks, and 8 weeks
Timed up and Go test
Time Frame: Change from baseline at the first day, 4 weeks, and 8 weeks
Change from baseline at the first day, 4 weeks, and 8 weeks
Stroke Impact Scale
Time Frame: Change from baseline at the first day, 4 weeks, and 8 weeks
quality of life
Change from baseline at the first day, 4 weeks, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

May 31, 2023

Study Completion (ANTICIPATED)

May 31, 2023

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (ACTUAL)

June 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YM109073F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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