Clinical trial NCT06490276: Biofeedback Gait Training on Gait Quality in Stroke
Official title: Effects of Biofeedback Gait Training on Gait Quality Post-stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Biofeedback
Gait symmetry
Gait variability
Gait training
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gait symmetry
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
measure: Gait variability
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Secondary outcomes:
measure: Propulsive force
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
measure: Gait performance
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
measure: Berg Balance Scale
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
measure: Taiwan Chinese version Falls Efficacy Scale
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
measure: Frenchay Activities Index
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
measure: Stroke Impact Scale
timeFrame: Change from baseline at 4 weeks after training and 4 weeks follow-up
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References: