Clinical trial NCT06000904: Strategy of Turning Performance in Individuals With Stroke
Official title: Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Turning performance
Balance performance
Exergame
Balance training
Stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-blind randomized controlled trial study. Thirty individuals with chronic stroke will be recruited and randomly assigned to the experimental and control groups. Subjects in the experimental group will receive exergame-based balance training, while subjects in the control group will receive upper limb and trunk training. Both groups will undergo a four-week intervention consisting of three sessions per week, each lasting 60 minutes.


Eligibility criteria: Inclusion Criteria:

* aged ≥18 years
* single incident of stroke
* stroke duration of at least 6 months
* lower limb Brunnstrom motor recovery stage between level three and five
* Functional Ambulation Categories scale ≥3

Exclusion Criteria:

* Individuals with cognitive impairmen (the Mini-Mental State Examination with a score below 24)
* visual or auditory impairments
* communication disorders
* other neurological diseases affecting motor performance, or any orthopedic conditions that could influence walking ability
* contraindications to physical activity, such as angina or uncontrolled hypertension

Primary outcomes:
measure: Turning velocity (degrees/second)
timeFrame: Change from baseline at 4 weeks
measure: Number of steps taken during turning
timeFrame: Change from baseline at 4 weeks
measure: Turning step length (cm)
timeFrame: Change from baseline at 4 weeks
measure: Stance phase duration (%) during turning
timeFrame: Change from baseline at 4 weeks
measure: Swing phase duration (%) during turning
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Change from baseline at 4 weeks
measure: Limits of stability test
timeFrame: Change from baseline at 4 weeks
measure: Modified clinical test of sensory interaction in balance
timeFrame: Change from baseline at 4 weeks
measure: Walking velocity (cm/sec) in straight walk
timeFrame: Change from baseline at 4 weeks
measure: Step length (cm) in straight walk
timeFrame: Change from baseline at 4 weeks
measure: Cadence (steps/minute) in straight walk
timeFrame: Change from baseline at 4 weeks
measure: Stance phase duration (%) in straight walk
timeFrame: Change from baseline at 4 weeks
measure: Swing phase duration (%) in straight walk
timeFrame: Change from baseline at 4 weeks
measure: Time Up and Go test
timeFrame: Change from baseline at 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References: