NCT07596225

Brief Summary

Study, titled Effects of Kinect-Based Exergaming versus Wii Fit on Balance and Fall Risk among Healthy Older Adults, is a randomized controlled trial comparing the balance training effects of Xbox Kinect and Wii Fit. After obtaining informed consent, 46 healthy older adults will be randomly allocated (1:1) using sealed envelopes to a 6-week training program in either group. Static, Dynamic, and Anticipatory balance will be assessed at baseline and post-intervention using the Biodex Balance System for objective comparison.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
May 2026Jul 2026

First Submitted

Initial submission to the registry

May 4, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 4, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Postural BalancePostural ControlAccidental FallsRisk factorsAgedvirtual realityvideo gamesrehabilitation

Outcome Measures

Primary Outcomes (7)

  • Postural stability

    Static postural stability will be assessed using the Biodex Balance System SD at stability level 12. The Overall Stability Index (OSI) measures the variance of platform displacement during static standing. The Overall Stability Index (OSI) is expressed in degrees. Lower OSI values indicate better postural stability and reduced postural sway, whereas higher values indicate impaired balance control. Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes

    6 weeks.

  • Balance

    Berg Balance scale will be used. 5-point ordinal scale (graded 0-4), Max score = 56 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk R=0.88-0.98.

    6 weeks

  • Concern of Fall

    Fall Efficacy Scale will be used. 16 items Questionnaire. Individuals are instructed to score their concern of falling during an activity. Performed at the start of the treatment protocol, and after 8 weeks at the end of the intervention 1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total of 64. 16 = no concern about falling, \> 16 = concern about falling

    6 weeks

  • Cognition

    Montreal Cognitive Assessment (MoCA) A 30-item global cognitive screening tool scored from 0-30. Higher scores indicate better cognition. 26-30: Normal cognition 18-25: Mild cognitive impairment (MCI) 10-17: Moderate cognitive impairment ≤ 9: Severe cognitive impairment One extra point is added for individuals with ≤12 years of formal education to adjust for educational bias

    6 weeks

  • Dynamic balance

    Dynamic balance will be assessed using the Biodex Balance System SD at stability level 6 under unstable surface conditions. Balance performance will be quantified using the Overall Stability Index (OSI). The Overall Stability Index (OSI) is expressed in degrees.Lower OSI scores represent improved dynamic balance and neuromuscular control, whereas higher values indicate poorer balance performance. Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes

    6 weeks

  • Limits of Stability

    Limits of Stability testing will be used to assess the participant's ability to intentionally displace the center of pressure toward visual targets without losing balance. Higher LOS scores indicate better anticipatory postural control and balance performance, whereas lower scores indicate impaired balance ability. Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes

    6 weeks

  • Fall Risk Index

    The Fall Risk Test using the Biodex Balance System will assess the participant's risk of falls under progressively unstable conditions. Higher Fall Risk Index scores indicate greater fall risk and poorer balance ability, whereas lower scores indicate improved balance and reduced fall risk. Assessment will be performed at baseline and after 6 weeks of intervention.

    6 week

Study Arms (2)

Group A

EXPERIMENTAL

Participants in this group will engage in four interactive mini-games from the Kinect Adventures collection, specifically selected for their dynamic full-body demands: Games will be 1. 20,000 leaks 2. Reflex ridge 3. River rush and 4. Rally ball The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40-50 minutes/day

Procedure: Virtual Reality Balance Training

Group B

EXPERIMENTAL

Participants in this group will engage in four interactive games , specifically selected for their dynamic full-body demands.These games collectively target key balance components,static control, dynamic adjustment, and anticipatory balance Games will be 1. Lotus focus 2. Soccer header, 3. Tight rope walk and 4. Ski slalom. The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40-50 minutes/day.

Procedure: Wii Fit balance training

Interventions

The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40- 50 minutes/day (18). Group 1 will receive Kinect-based exergaming balance training. Warm-up exercise will be for 5 minutes, including gentle stretching exercises, and 5 minutes will be given for a cool down, including deep breathing exercises Group (A) / (Kinect-based Exergaming balance training): 1. 20,000 leaks 2. Reflex ridge 3. River rush 4. Rally ball

Group A

The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40- 50 minutes/day (18). Group 2 will receive Wii Fit balance training. Warm-up exercise will be for 5 minutes, including gentle stretching exercises, and 5 minutes will be given for a cool down, including deep breathing exercises Group (B) / Wii Fit balance training: 1. Soccer header 2. Lotus Focus(Minimal) 3. Tightrope Walk 4. Ski slalom

Group B

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults aged ≥55, community-dwelling, with a BBS score between 21-50, including both mild to moderate Risk falls
  • Able to stand without assistive devices
  • Cognitively able to follow instructions, with a MoCA score ≥ 22
  • Both Genders: Males and females

You may not qualify if:

  • History of Neurological disorders affecting balance (e.g., Parkinson's disease, stroke)
  • Acute Vestibular disorders/Major Musculoskeletal impairments (e.g., Arthritis)
  • Participation in other balance training programs within the past 6 months
  • Any condition posing a safety risk (e.g., severe osteoporosis, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, Punjab Province, 44000, Pakistan

RECRUITING

Study Officials

  • Nayab Khan, DPT

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Ehab Azim, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study will be conducted as a single-blinded randomized controlled trial. The outcome assessor will be blinded to group allocation to minimize detection bias. The assessor performing evaluations using the Berg Balance Scale, Falls Efficacy Scale, Montreal Cognitive Assessment, and Biodex Balance System will not be informed whether participants are assigned to the Xbox Kinect or Wii Fit group. Participants and therapists cannot be blinded due to the nature of the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial which will consists of two groups .one will receive kinect based exergaming and the second will recieve Wiifit balance training .both groups will be recruitted concurrently
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 19, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations