NCT06978517

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 11, 2025

Last Update Submit

May 11, 2025

Conditions

Keywords

Fall riskpostural stabilityBiodex balance systemNintendo Wii fit

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    8 weeks

Study Arms (2)

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

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

Procedure: nintendo Wii fit balance training

Interventions

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.

Biodex balance system

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.

Nintendo Wii fit

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55years and above
  • Males and females both
  • Berg balance scale score 21-40
  • TUG in less than 20 sec

You may not qualify if:

  • Use of a wheelchair or walker.
  • Any diagnosed neurological condition.
  • Any severe musculoskeletal condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2025

First Posted

May 18, 2025

Study Start

June 20, 2024

Primary Completion

December 20, 2024

Study Completion

May 10, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations