Biofeedback Gait Training on Gait Quality in Stroke

NCT06490276 | Recruiting

• 1 other identifier: NYCU112205AF2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. Previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. However, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. Therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with stroke.

Conditions

Stroke

Keywords

Biofeedback; Gait symmetry; Gait variability; Gait training

Outcome Measures

Primary Outcomes (2)

• Gait symmetry

  Using GAITRite system to measure the symmetry of saptiotemporal parameters

  Change from baseline at 4 weeks after training and 4 weeks follow-up

• Gait variability

  Using GAITRite system to measure the coefficient of variation of saptiotemporal parameters

  Change from baseline at 4 weeks after training and 4 weeks follow-up

Secondary Outcomes (7)

• Propulsive force

  Change from baseline at 4 weeks after training and 4 weeks follow-up

• Gait performance

  Change from baseline at 4 weeks after training and 4 weeks follow-up

• Berg Balance Scale

  Change from baseline at 4 weeks after training and 4 weeks follow-up

• Activities-specific Balance Confidence Scale

  Change from baseline at 4 weeks after training and 4 weeks follow-up

• Taiwan Chinese version Falls Efficacy Scale

  Change from baseline at 4 weeks after training and 4 weeks follow-up

Study Arms (2)

Gait training with biofeedback group

EXPERIMENTAL

The intervention is a 60-minute session and 3 sessions/week, totaling 4 weeks.

Other: Gait training with biofeedback

Gait training without biofeedback group

ACTIVE COMPARATOR

The intervention is a 60-minute session and 3 sessions/week, totaling 4 weeks.

Other: Gait training without biofeedback

Interventions

Gait training with biofeedback OTHER

Gait training include treadmill and overground walking. The biofeedback device system will provide real-time feedback on hip extension angles.

Gait training with biofeedback group

Gait training without biofeedback OTHER

Gait training include treadmill and overground walking.

Gait training without biofeedback group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First stroke
• Stroke onset time ≥ 6 months
• Functional Ambulation Category ≥3
• Passive range of motion of affected hip extension is at least 10 degrees
• Mini-Mental State Measurement score ≥ 24 points

You may not qualify if:

• Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
• Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
• Uncorrected auditory impairment
• Severe cardiovascular disease or uncontrolled hypertension
• Other orthopedic diseases that may affect walking ability
• Other neurological disease except stroke

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

+886228267279; yryang@nycu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 8, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

TW (1)