Back to resultsStrategy of Turning Performance in Individuals With Stroke
Primary Purpose
Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exergame-based balance training
Upper limb and trunk training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Turning performance, Balance performance, Exergame, Balance training, Stroke
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
Sites / Locations
- Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exergame-based balance training group
Upper limb and trunk training group
Arm Description
Outcomes
Primary Outcome Measures
Turning velocity (degrees/second)
Number of steps taken during turning
Turning step length (cm)
Stance phase duration (%) during turning
Swing phase duration (%) during turning
Secondary Outcome Measures
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.
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.
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.
Walking velocity (cm/sec) in straight walk
Step length (cm) in straight walk
Cadence (steps/minute) in straight walk
Stance phase duration (%) in straight walk
Swing phase duration (%) in straight walk
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.
Full Information
NCT ID
NCT06000904
First Posted
August 6, 2023
Last Updated
August 13, 2023
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT06000904
Brief Title
Strategy of Turning Performance in Individuals With Stroke
Official Title
Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 21, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Turning performance, Balance performance, Exergame, Balance training, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exergame-based balance training group
Arm Type
Experimental
Arm Title
Upper limb and trunk training group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Exergame-based balance training
Intervention Description
For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute balance exercise, and 15-minute ground walking as a cool-down.
Intervention Type
Other
Intervention Name(s)
Upper limb and trunk training
Intervention Description
For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute upper-limb and trunk exercise, and 15-minute ground walking as a cool-down.
Primary Outcome Measure Information:
Title
Turning velocity (degrees/second)
Time Frame
Change from baseline at 4 weeks
Title
Number of steps taken during turning
Time Frame
Change from baseline at 4 weeks
Title
Turning step length (cm)
Time Frame
Change from baseline at 4 weeks
Title
Stance phase duration (%) during turning
Time Frame
Change from baseline at 4 weeks
Title
Swing phase duration (%) during turning
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
Change from baseline at 4 weeks
Title
Limits of stability test
Description
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.
Time Frame
Change from baseline at 4 weeks
Title
Modified clinical test of sensory interaction in balance
Description
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.
Time Frame
Change from baseline at 4 weeks
Title
Walking velocity (cm/sec) in straight walk
Time Frame
Change from baseline at 4 weeks
Title
Step length (cm) in straight walk
Time Frame
Change from baseline at 4 weeks
Title
Cadence (steps/minute) in straight walk
Time Frame
Change from baseline at 4 weeks
Title
Stance phase duration (%) in straight walk
Time Frame
Change from baseline at 4 weeks
Title
Swing phase duration (%) in straight walk
Time Frame
Change from baseline at 4 weeks
Title
Time Up and Go test
Description
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.
Time Frame
Change from baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Strategy of Turning Performance in Individuals With Stroke
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