Fall RiskNCT06978517
Effect of Postural Stability System Comparison to Nintendo Wii Fit Balance Training on Fall Risk and Postural Stability in Elderly
A study testing Biodex balance system and nintendo Wii fit balance training in people with Fall Risk and Postural Stability, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Human balance is a complex multidimensional concept related to postural control, and it refers essentially to the ability to maintain a posture (e.g., sitting or standing), move between postures, and not fall when reacting to an external disturbance. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Risk, Postural Stability, Balance
- What is being tested?
- Biodex balance system and nintendo Wii fit balance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 10 May 2025
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55years and above
- Males and females both
- Berg balance scale score 21-40
- TUG in less than 20 sec
Who cannot join
- Use of a wheelchair or walker.
- Any diagnosed neurological condition.
- Any severe musculoskeletal condition.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, 44000
About this study
Human balance is a complex multidimensional concept related to postural control, and it refers essentially to the ability to maintain a posture (e.g., sitting or standing), move between postures, and not fall when reacting to an external disturbance. One-third to one-half of the population over age 65 reports some difficulty with balance or ambulation .Because of the high incidence of balance and mobility disorders in older adults, interventions are necessary that optimize the performance of balance- and mobility-related activities older adults .
The aim of the current study will benefit clinicians and physiotherapists as it provide an insight to the benefits of balance training. The practical application of balance training will provide neurological advantages tothe geriatric population to allow lesser fall risk and postural instability.
The study will be a non-blinded randomized control trial, consisting of two groups. Study will be conducted over 1 year. Subjects will be selected via a non-probability purposive sampling technique using a coin toss method, followed by randomization into two groups (A and B). Ethical approval will be obtained from the ERC FUMC. One group will receive Nintendo Wii Fit balance training while the second group will receive postural stability system training over 8 weeks. Baseline tests will be performed before and after the intervention for balance, postural stability, and sensory integration. Data will be entered and analyzed on SPSS version 22.
- Conditions
- Fall Risk, Postural Stability, Balance, Elderly
- Being tested
- Biodex balance system, nintendo Wii fit balance training
- Keywords
- Fall risk, postural stability, Biodex balance system, Nintendo Wii fit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex balance systemProcedure or surgery
Participants assigned to the Biodex balance training group underwent balance rehabilitation using the Biodex Balance System SD, a computerized platform designed to assess and train postural stability. Each participant engaged in training sessions three times per week, with each session lasting approximately 30 minutes, over a total period of six weeks. The intervention began with exercises conducted on a higher stability level (e.g., Level 8), gradually progressing to lower stability levels (e.g., Level 2) to increase the challenge as participants' balance improved. The training included both static and dynamic tasks aimed at enhancing weight shifting, center-of-gravity control, and response to instability. Real-time visual biofeedback was provided via the system's screen, enabling participants to monitor their performance and maintain motivation. All sessions were conducted under the supervision of a qualified physiotherapist to ensure proper technique and safety.
nintendo Wii fit balance trainingProcedure or surgery
Participants in the Nintendo Wii Fit training group engaged in balance exercises using the Nintendo Wii console and Wii Fit balance board. This interactive system includes a variety of balance-focused activities and games that simulate real-life balance challenges in a virtual environment. The training was conducted three times per week, with each session lasting approximately 30 minutes, over a six-week period. Exercises included selected Wii Fit balance games (such as Ski Slalom, Table Tilt, and Tightrope Walk) and yoga-based poses (such as Tree Pose and Warrior), which encouraged participants to engage their core and lower limb muscles while maintaining postural alignment. The difficulty level was gradually increased by introducing more complex tasks and longer balance durations as participants progressed. The system provided immediate visual and auditory feedback, allowing users to track their scores and improvements in real time. All sessions were performed under supervision.
| Study group | Role | What they receive |
|---|---|---|
| Biodex balance system | Experimental | It includes the following techniques for training: weight shift training, limits of stability, and weight training techniques It includes 15 participants and includes warm-up and cool-down period Receives: Procedure: Biodex balance system |
| Nintendo Wii fit | Active comparator | Nintendo Wii Fit Balance Training, which includesthe following games:
* table tilt
* ski slalom
* Penguin slide
* Tightrope walk
* Soccer heading
* Balance bubble It includes 15 participants and playing each game for 10 minutes Receives: Procedure: nintendo Wii fit balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Berg balance scale is used to assess functional balance and mobility, particularly in the elderly and those with balance impairment. It's a 14-item scale where each item is scored on a 5-point scale (0-4), with a total score ranging from 0 to 56. The higher the score, the better the patient's balance
Measured: 8 weeks
Fall risk
The Timed Up and Go (TUG) test is a simple and widely used assessment of fall risk that measures the time it takes for someone to rise from a chair, walk a certain distance (usually 3 meters), turn around, and walk back to sit down.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start20 Jun 2024
- Primary completion20 Dec 2024
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall RiskStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978517
- Sponsor's protocol ID
- FUI/CTR/2024/73
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postural Stability System Comparison to Nintendo Wii Fit Balance Training on Fall Risk and Postural Stability in Elderly
- ClinicalTrials.gov ID
- NCT06978517
- Acronym / sponsor ID
- FUI/CTR/2024/73
- Conditions
- Fall Risk, Postural Stability, Balance, Elderly
- Keywords
- Fall risk, postural stability, Biodex balance system, Nintendo Wii fit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 18 May 2025 (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.
Human balance is a complex multidimensional concept related to postural control, and it refers essentially to the ability to maintain a posture (e.g., sitting or standing), move between postures, and not fall when reacting to an external disturbance. One-third to one-half of the population over age 65 reports some difficulty with balance or ambulation .Because of the high incidence of balance and mobility disorders in older adults, interventions are necessary that optimize the performance of balance- and mobility-related activities older adults .
The aim of the current study will benefit clinicians and physiotherapists as it provide an insight to the benefits of balance training. The practical application of balance training will provide neurological advantages tothe geriatric population to allow lesser fall risk and postural instability.
The study will be a non-blinded randomized control trial, consisting of two groups. Study will be conducted over 1 year. Subjects will be selected via a non-probability purposive sampling technique using a coin toss method, followed by randomization into two groups (A and B). Ethical approval will be obtained from the ERC FUMC. One group will receive Nintendo Wii Fit balance training while the second group will receive postural stability system training over 8 weeks. Baseline tests will be performed before and after the intervention for balance, postural stability, and sensory integration. Data will be entered and analyzed on SPSS version 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodex balance system | Experimental | Procedure: Biodex balance systemIt includes the following techniques for training: weight shift training, limits of stability, and weight training techniques It includes 15 participants and includes warm-up and cool-down period |
| Nintendo Wii fit | Active comparator | Procedure: nintendo Wii fit balance trainingNintendo Wii Fit Balance Training, which includesthe following games: * table tilt * ski slalom * Penguin slide * Tightrope walk * Soccer heading * Balance bubble It includes 15 participants and playing each game for 10 minutes |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55years and above
- Males and females both
- Berg balance scale score 21-40
- TUG in less than 20 sec
Key exclusion criteria (3 listed)
- Use of a wheelchair or walker.
- Any diagnosed neurological condition.
- Any severe musculoskeletal condition.
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 |
|---|---|---|
| Biodex balance systemParticipants assigned to the Biodex balance training group underwent balance rehabilitation using the Biodex Balance System SD, a computerized platform designed to assess and train postural stability. Each participant engaged in training sessions three times per week, with each session lasting approximately 30 minutes, over a total period of six weeks. The intervention began with exercises conducted on a higher stability level (e.g., Level 8), gradually progressing to lower stability levels (e.g., Level 2) to increase the challenge as participants' balance improved. The training included both static and dynamic tasks aimed at enhancing weight shifting, center-of-gravity control, and response to instability. Real-time visual biofeedback was provided via the system's screen, enabling participants to monitor their performance and maintain motivation. All sessions were conducted under the supervision of a qualified physiotherapist to ensure proper technique and safety. | Procedure or surgery | Biodex balance system |
| nintendo Wii fit balance trainingParticipants in the Nintendo Wii Fit training group engaged in balance exercises using the Nintendo Wii console and Wii Fit balance board. This interactive system includes a variety of balance-focused activities and games that simulate real-life balance challenges in a virtual environment. The training was conducted three times per week, with each session lasting approximately 30 minutes, over a six-week period. Exercises included selected Wii Fit balance games (such as Ski Slalom, Table Tilt, and Tightrope Walk) and yoga-based poses (such as Tree Pose and Warrior), which encouraged participants to engage their core and lower limb muscles while maintaining postural alignment. The difficulty level was gradually increased by introducing more complex tasks and longer balance durations as participants progressed. The system provided immediate visual and auditory feedback, allowing users to track their scores and improvements in real time. All sessions were performed under supervision. | Procedure or surgery | Nintendo Wii fit |
Primary outcome
Balance
Time frame: 8 weeks
Berg balance scale is used to assess functional balance and mobility, particularly in the elderly and those with balance impairment. It's a 14-item scale where each item is scored on a 5-point scale (0-4), with a total score ranging from 0 to 56. The higher the score, the better the patient's balance
Fall risk
Time frame: 8 weeks
The Timed Up and Go (TUG) test is a simple and widely used assessment of fall risk that measures the time it takes for someone to rise from a chair, walk a certain distance (usually 3 meters), turn around, and walk back to sit down.
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 18 May 2025.
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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 Biodex balance system and nintendo Wii fit balance training in people with Fall Risk and Postural Stability, run by Foundation University Islamabad at 1 site in Pakistan.
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 18 May 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 Pakistan. 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?
Balance (time frame: 8 weeks). 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 18 May 2025.