StrokeNCT06000904
Strategy of Turning Performance in Individuals With Stroke
A study testing Exergame-based balance training and Upper limb and trunk training in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Exergame-based balance training and Upper limb and trunk training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Taipei, 112
Yea-Ru Yang, PhD, +886-2-2826-7279, yryang@nycu.edu.tw
About this study
Official title: Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
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.
- Conditions
- Stroke
- Being tested
- Exergame-based balance training, Upper limb and trunk training
- Keywords
- Turning performance, Balance performance, Exergame, Balance training, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame-based balance trainingOther
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.
Upper limb and trunk trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exergame-based balance training group | Experimental | Not described Receives: Other: Exergame-based balance training |
| Upper limb and trunk training group | Active comparator | Not described Receives: Other: Upper limb and trunk training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turning velocity (degrees/second)
Measured: Change from baseline at 4 weeks
Number of steps taken during turning
Measured: Change from baseline at 4 weeks
Turning step length (cm)
Measured: Change from baseline at 4 weeks
Stance phase duration (%) during turning
Measured: Change from baseline at 4 weeks
Swing phase duration (%) during turning
Measured: Change from baseline at 4 weeks
Secondary outcomes (9)
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.
Measured: Change from baseline at 4 weeks
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.
Measured: Change from baseline at 4 weeks
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.
Measured: Change from baseline at 4 weeks
Walking velocity (cm/sec) in straight walk
Measured: Change from baseline at 4 weeks
Step length (cm) in straight walk
Measured: Change from baseline at 4 weeks
Cadence (steps/minute) in straight walk
Measured: Change from baseline at 4 weeks
Stance phase duration (%) in straight walk
Measured: Change from baseline at 4 weeks
Swing phase duration (%) in straight walk
Measured: Change from baseline at 4 weeks
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.
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start19 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000904
- Sponsor's protocol ID
- NYCU112118AF
- Status last verified
- Jun 2024
- First submitted
- 6 Aug 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT06000904
- Acronym / sponsor ID
- NYCU112118AF
- Conditions
- Stroke
- Keywords
- Turning performance, Balance performance, Exergame, Balance training, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame-based balance training group | Experimental | Other: Exergame-based balance training |
| Upper limb and trunk training group | Active comparator | Other: Upper limb and trunk training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergame-based balance trainingFor 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. | Other | Exergame-based balance training group |
| Upper limb and trunk trainingFor 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. | Other | Upper limb and trunk training group |
Primary outcome
Turning velocity (degrees/second)
Time frame: Change from baseline at 4 weeks
Number of steps taken during turning
Time frame: Change from baseline at 4 weeks
Turning step length (cm)
Time frame: Change from baseline at 4 weeks
Stance phase duration (%) during turning
Time frame: Change from baseline at 4 weeks
Swing phase duration (%) during turning
Time frame: Change from baseline at 4 weeks
9 secondary outcomes
Berg Balance Scale
Time frame: Change from baseline at 4 weeks
Limits of stability test
Time frame: Change from baseline at 4 weeks
Modified clinical test of sensory interaction in balance
Time frame: Change from baseline at 4 weeks
Walking velocity (cm/sec) in straight walk
Time frame: Change from baseline at 4 weeks
Step length (cm) in straight walk
Time frame: Change from baseline at 4 weeks
Cadence (steps/minute) in straight walk
Time frame: Change from baseline at 4 weeks
Stance phase duration (%) in straight walk
Time frame: Change from baseline at 4 weeks
Swing phase duration (%) in straight walk
Time frame: Change from baseline at 4 weeks
Time Up and Go test
Time frame: Change from baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame-based balance training and Upper limb and trunk training in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turning velocity (degrees/second) (time frame: Change from baseline at 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.