Stroke Clinical Trial
Official title:
Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
Verified date | August 2023 |
Source | National Yang Ming University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Yang Ming University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Turning velocity (degrees/second) | Change from baseline at 4 weeks | ||
Primary | Number of steps taken during turning | Change from baseline at 4 weeks | ||
Primary | Turning step length (cm) | Change from baseline at 4 weeks | ||
Primary | Stance phase duration (%) during turning | Change from baseline at 4 weeks | ||
Primary | Swing phase duration (%) during turning | Change from baseline at 4 weeks | ||
Secondary | Berg Balance Scale | The Berg Balance Scale is employed to evaluate the functional balance ability of the subjects. This tool comprises 14 individual tests, each scored on a scale from 0 to 4, resulting in a total score of 56. A higher score indicates better balance ability. | Change from baseline at 4 weeks | |
Secondary | Limits of stability test | The limits of stability test is used to evaluate the dynamic balance ability of participants. Overall percentage is defined as the amount of direction control accuracy the individual has when performing the test. A higher percentage reflects better performance. | Change from baseline at 4 weeks | |
Secondary | Modified clinical test of sensory interaction in balance | This test is designed to assess sensory integration ability basing on the conditions of eyes open or closed and stable or unstable ground. The test is conducted in four contexts: context 1 involves standing with eyes open on a firm surface; context 2 involves standing with eyes open on a foam cushion; context 3 involves standing with eyes closed on a firm surface; and context 4 involves standing with eyes closed on a foam cushion. The overall sway index will be recorded for each condition of each trial, which will be summed the average of each condition. | Change from baseline at 4 weeks | |
Secondary | Walking velocity (cm/sec) in straight walk | Change from baseline at 4 weeks | ||
Secondary | Step length (cm) in straight walk | Change from baseline at 4 weeks | ||
Secondary | Cadence (steps/minute) in straight walk | Change from baseline at 4 weeks | ||
Secondary | Stance phase duration (%) in straight walk | Change from baseline at 4 weeks | ||
Secondary | Swing phase duration (%) in straight walk | Change from baseline at 4 weeks | ||
Secondary | Time Up and Go test | The Timed Up & Go (TUG) test is employed to evaluate the activity functionality of participants. The average time taken for completion will be recorded for analysis. | Change from baseline at 4 weeks |
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