StrokeNCT06166004
The Effects of Balance Trainer
A study testing Balance Training and Person-Specific Rehabilitation Program in people with Stroke and Virtual Reality, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The trunk is reference and key region of body in terms of both mobility and stability. Sufficient stability in the trunk is essential for the execution of intentional extremity movements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Virtual Reality
- What is being tested?
- Balance Training and Person-Specific Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Aug 2023to 31 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having the ICD-10 diagnosis code G.81 Hemiplegia
- At least 3 weeks having passed since the diagnosis (Subacute and later periods)
- Being 18 years of age or older
- Having a Berg Balance Score between 21-40 (indicating an acceptable balance)
Who cannot join
- Having a known additional neurological or orthopedic problem that could affect balance
- Not being cognitively able to understand and perform exercises
- Having a diagnosis date that is more than 2 years from the initial evaluation date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Balance Trainer-Based Training on Balance and Trunk Control in Stroke Survivors
The trunk is reference and key region of body in terms of both mobility and stability. Sufficient stability in the trunk is essential for the execution of intentional extremity movements. Therefore, even in conditions with significant extremity impairment, such as stroke, trunk functionality is a crucial factor affecting the success of treatment. The Balance Trainer is a device used for balance rehabilitation. However, the patient's use of the trunk is also intense during trunk exercises. The aim of the study is to contribute to the literature by examining the development of trunk control, a component of both balance and stability, through the use of the Balance Trainer.
Read the detailed description
Stroke is one of the leading causes of death in adults and significantly contributes to severe disability. Balance problems are among the most common issues following a stroke, affecting the patient's ability to sit, stand, transfer, and walk, thereby posing a risk of falls. Balance rehabilitation can be instrumental in addressing these challenges. For instance, clinicians may decide to allocate more time to safe transfers or wheelchair skills for individuals with a Berg Balance Scale (BBS) score below 12. Conversely, those scoring 29 or higher on the BBS may warrant an increase in the intensity and duration of walking training, as they are likely to progress to community-appropriate walking speeds.
The trunk, located at the body's center, plays a crucial role in organizing postural control and balance reactions. A healthy trunk is essential for the successful execution of both lower and upper extremity functions. Trunk control is necessary to provide a stable support base during the execution of lower and upper extremity movements, requiring active involvement of the trunk in daily life activities such as reaching.
The Balance-Trainer is a technology-based biofeedback-controlled system used in individuals with Multiple Sclerosis, Stroke, Muscle Diseases, and geriatric populations. The device includes balance exercises involving weight shifting in different directions through games like Collect Apples, Outline, Paddle War, and Evaluation of Movement. Reviewing the literature reveals that exercise devices incorporating virtual reality are effective in improving balance.
The research, designed as a prospective study with two parallel groups, aims to investigate the effects of balance training with the Balance-Trainer (BT) on trunk control, balance, and fall risk in stroke patients. The hypothesis is that balance training with BT will positively impact trunk control and balance. The study population consists of patients undergoing treatment for stroke (ICD.10 G.81 Hemiplegia) at Ankara City Hospital Physical Therapy and Rehabilitation Hospital.
Volunteers meeting the inclusion criteria from stroke patients receiving treatment at Ankara City Hospital Physical Therapy and Rehabilitation Hospital will be enrolled in the research. Participants involved in the study will continue their standard rehabilitation program. Those directed by their physician for BT will be included in the study group, while stroke patients voluntarily not receiving balance training with BT during their stroke clinic treatments will be included in the control group.
Both study and control groups in the research will continue individualized rehabilitation programs for three weeks, five days a week. This program includes stretching and strengthening exercises, mat activities such as bridging, joint range of motion exercises, static and dynamic balance exercises, and walking exercises. Exercises are selected based on the patient's needs. In addition to the individualized rehabilitation program, the study group will engage in 15 sessions of BT balance exercises over three weeks, with five sessions per week and each session lasting 30 minutes.
- Conditions
- Stroke, Virtual Reality
- Being tested
- Balance Training, Person-Specific Rehabilitation Program
- Keywords
- Stroke, Virtual Reality, Balance-Trainer, Thera-Trainer, Rehabilitation Technologies
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance TrainingOther
Also called Thera Trainer Balo
Balance Training device with VR
Person-Specific Rehabilitation ProgramOther
Person-Specific Rehabilitation Program
| Study group | Role | What they receive |
|---|---|---|
| BalanceTrainer | Experimental | Balance Trainer Exercises (30 min) Person-Specific Rehabilitation Program
1. Stretching and Strengthening Exercises
2. Mat Activities
3. Joint Range of Motion Exercises
4. Static and Dynamic Balance Exercises
5. Walking Exercises Receives: Other: Balance Training; Other: Person-Specific Rehabilitation Program |
| Control Group | Other | Person-Specific Rehabilitation Program
1. Stretching and Strengthening Exercises
2. Mat Activities
3. Joint Range of Motion Exercises
4. Static and Dynamic Balance Exercises
5. Walking Exercises Receives: Other: Person-Specific Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Imapirment Scale
It is a standardized scale designed for assessing the trunk after a stroke. It consists of three sections: static sitting balance, dynamic sitting balance, and coordination, with a maximum score of 23. In our research, it will be utilized to evaluate patients' trunk control after a stroke.
Measured: Baseline and 3 weeks later
Berg Balance Scale
This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.
Measured: Baseline and 3 weeks later
Secondary outcomes (3)
Functional Independence Measure
The Functional Independence Measure is a valid and reliable scale for assessing stroke patients, comprising 18 items that evaluate the patient both physically and cognitively. These items are primarily grouped under the headings of Self-Care, Sphincter Control, Transfer, Locomotion, Communication, and Social Cognition.
Measured: Baseline and 3 weeks later
Falls Efficacy Scale-International
This scale, expanded to 16 items with additions to the original scale developed by Tinetti et al. (1990), assesses the fear of falling and future fall risks. The validity and reliability of the Turkish version of the scale have been established by Ulus et al. (2012)
Measured: Baseline and 3 weeks later
Functional Ambulation Category
It assesses the amount of physical support needed during walking, scoring from 0 to 5, with observations made through the assessment. The scoring is based on the amount of support the patient requires, ranging from 0 - indicating inability to ambulate independently and requiring maximum support, to 5 - defining a patient who can walk independently on all surfaces.
Measured: Baseline and 3 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start23 Aug 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Akıncı, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166004
- Sponsor's protocol ID
- BT01
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 20 Feb 2025
- 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Balance Trainer-Based Training on Balance and Trunk Control in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06166004
- Acronym / sponsor ID
- BT01
- Conditions
- Stroke, Virtual Reality
- Keywords
- Stroke, Virtual Reality, Balance-Trainer, Thera-Trainer, Rehabilitation Technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 Dec 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.
The trunk is reference and key region of body in terms of both mobility and stability. Sufficient stability in the trunk is essential for the execution of intentional extremity movements. Therefore, even in conditions with significant extremity impairment, such as stroke, trunk functionality is a crucial factor affecting the success of treatment. The Balance Trainer is a device used for balance rehabilitation. However, the patient's use of the trunk is also intense during trunk exercises. The aim of the study is to contribute to the literature by examining the development of trunk control, a component of both balance and stability, through the use of the Balance Trainer.
Detailed description
Stroke is one of the leading causes of death in adults and significantly contributes to severe disability. Balance problems are among the most common issues following a stroke, affecting the patient's ability to sit, stand, transfer, and walk, thereby posing a risk of falls. Balance rehabilitation can be instrumental in addressing these challenges. For instance, clinicians may decide to allocate more time to safe transfers or wheelchair skills for individuals with a Berg Balance Scale (BBS) score below 12. Conversely, those scoring 29 or higher on the BBS may warrant an increase in the intensity and duration of walking training, as they are likely to progress to community-appropriate walking speeds.
The trunk, located at the body's center, plays a crucial role in organizing postural control and balance reactions. A healthy trunk is essential for the successful execution of both lower and upper extremity functions. Trunk control is necessary to provide a stable support base during the execution of lower and upper extremity movements, requiring active involvement of the trunk in daily life activities such as reaching.
The Balance-Trainer is a technology-based biofeedback-controlled system used in individuals with Multiple Sclerosis, Stroke, Muscle Diseases, and geriatric populations. The device includes balance exercises involving weight shifting in different directions through games like Collect Apples, Outline, Paddle War, and Evaluation of Movement. Reviewing the literature reveals that exercise devices incorporating virtual reality are effective in improving balance.
The research, designed as a prospective study with two parallel groups, aims to investigate the effects of balance training with the Balance-Trainer (BT) on trunk control, balance, and fall risk in stroke patients. The hypothesis is that balance training with BT will positively impact trunk control and balance. The study population consists of patients undergoing treatment for stroke (ICD.10 G.81 Hemiplegia) at Ankara City Hospital Physical Therapy and Rehabilitation Hospital.
Volunteers meeting the inclusion criteria from stroke patients receiving treatment at Ankara City Hospital Physical Therapy and Rehabilitation Hospital will be enrolled in the research. Participants involved in the study will continue their standard rehabilitation program. Those directed by their physician for BT will be included in the study group, while stroke patients voluntarily not receiving balance training with BT during their stroke clinic treatments will be included in the control group.
Both study and control groups in the research will continue individualized rehabilitation programs for three weeks, five days a week. This program includes stretching and strengthening exercises, mat activities such as bridging, joint range of motion exercises, static and dynamic balance exercises, and walking exercises. Exercises are selected based on the patient's needs. In addition to the individualized rehabilitation program, the study group will engage in 15 sessions of BT balance exercises over three weeks, with five sessions per week and each session lasting 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BalanceTrainer | Experimental | Other: Balance Training, Other: Person-Specific Rehabilitation ProgramBalance Trainer Exercises (30 min) Person-Specific Rehabilitation Program 1. Stretching and Strengthening Exercises 2. Mat Activities 3. Joint Range of Motion Exercises 4. Static and Dynamic Balance Exercises 5. Walking Exercises |
| Control Group | Other | Other: Person-Specific Rehabilitation ProgramPerson-Specific Rehabilitation Program 1. Stretching and Strengthening Exercises 2. Mat Activities 3. Joint Range of Motion Exercises 4. Static and Dynamic Balance Exercises 5. Walking Exercises |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having the ICD-10 diagnosis code G.81 Hemiplegia
- At least 3 weeks having passed since the diagnosis (Subacute and later periods)
- Being 18 years of age or older
- Having a Berg Balance Score between 21-40 (indicating an acceptable balance)
Key exclusion criteria (3 listed)
- Having a known additional neurological or orthopedic problem that could affect balance
- Not being cognitively able to understand and perform exercises
- Having a diagnosis date that is more than 2 years from the initial evaluation date
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 |
|---|---|---|
| Balance TrainingAlso: Thera Trainer BaloBalance Training device with VR | Other | BalanceTrainer |
| Person-Specific Rehabilitation ProgramPerson-Specific Rehabilitation Program | Other | BalanceTrainer, Control Group |
Primary outcome
Trunk Imapirment Scale
Time frame: Baseline and 3 weeks later
It is a standardized scale designed for assessing the trunk after a stroke. It consists of three sections: static sitting balance, dynamic sitting balance, and coordination, with a maximum score of 23. In our research, it will be utilized to evaluate patients' trunk control after a stroke.
Berg Balance Scale
Time frame: Baseline and 3 weeks later
This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.
3 secondary outcomes
Functional Independence Measure
Time frame: Baseline and 3 weeks later
Falls Efficacy Scale-International
Time frame: Baseline and 3 weeks later
Functional Ambulation Category
Time frame: Baseline and 3 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training and Person-Specific Rehabilitation Program in people with Stroke and Virtual Reality, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Feb 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Imapirment Scale (time frame: Baseline and 3 weeks later). The study lists 2 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 20 Feb 2025.