Treadmill With Biofeedback on Gait Symmetry After Stroke

Stroke Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04441541
• Other study ID #: YM109073F
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2020
• Source: National Yang Ming University
• Contact: Yang Yea-Ru, PhD
• Phone: 2826-7279
• Email: yryang[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Syndrome

Intervention

Other:
• Treadmill with auditory feedback
Participants will receive training 3 times per week for 4 weeks (12 sessions).
• Treadmill with visual feedback
Participants will receive training 3 times per week for 4 weeks (12 sessions).
• Treadmill with auditory and visual feedback
Participants will receive training 3 times per week for 4 weeks (12 sessions).
• Treadmill training
Participants will receive training 3 times per week for 4 weeks (12 sessions).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial and temporal gait symmetry	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	Walking speed		Change from baseline at the first day, 4 weeks, and 8 weeks
Secondary	6 Minute Walk Test		Change from baseline at the first day, 4 weeks, and 8 weeks
Secondary	Timed up and Go test		Change from baseline at the first day, 4 weeks, and 8 weeks
Secondary	Stroke Impact Scale	quality of life	Change from baseline at the first day, 4 weeks, and 8 weeks