NCT07308353

Brief Summary

This study explores whether non-immersive, interactive Exergaming using Xbox Kinect can go beyond conventional exercise by actively training the brain and body to react faster, balance smarter, and move more confidently. Through dynamic games like Reflex Ridge and 20,000 Leaks, we aim to stimulate internal perturbations and real-time Sensory Integration, something Otago doesn't directly target. In this randomized controlled trial, 36 older adults (aged 55+) will be assigned to either the Exergaming or Otago group. Both groups will receive 6 weeks of supervised balance training (3x/week, 30 mins/session). Primary outcomes include Sensory Integration, measured using modified Clinical Test of Sensory Interaction and Balance (mCTSIB) and Anticipatory postural control assessed through Limits of Stability (LOS) test. Timed up and Go (TUG) will capture functional mobility, which will serve as the secondary outcome in this study. Both mCTSIB and LOS will be administered using the Postural Stability System of Biodex, a reliable and valid computerized platform designed to objectively quantify postural control under varying sensory conditions. With evidence-based outcome tools and rigorous analysis, this project doesn't just aim to compare two programs, it's about challenging tradition, modernizing rehab, and making balance training smarter, safer, and more engaging for the elders we serve. This research could be a leap forward in community-based fall prevention and a step toward a more responsive, personalized future in Neurological Rehabilitation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress76%
Nov 2025Jul 2026

Study Start

First participant enrolled

November 18, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

ExergamingExercise TherapyFrail ElderlyHealthy AgingMobility limitationMuscle StrengthPostural BalanceProprioception

Outcome Measures

Primary Outcomes (3)

  • Anticipatory Postural Control

    It will be assessed using the Limits of Stability test of Postural Stability System (Biodex Balance System). The LOS test measures anticipatory postural control by evaluating the participant's ability to voluntarily shift their center of gravity (COG) toward multiple targets without losing balance. Participants will be instructed to shift their weight toward 8 targets displayed on a screen, using ankle and trunk strategies while standing on a stable platform. Overall LOS Score and Time to complete test will be recorded. Higher values of Overall Directional control indicate better anticipatory balance. Whereas shorter Time to Complete Test reflects quicker anticipatory responses.

    6 weeks

  • Sensory Integration

    The mCTSIB will be used to assess sensory integration.This test includes the four conditions: Eyes Open on Firm Surface, Eyes Closed on Firm Surface, Eyes Open, Foam Surface and Eyes Closed, Foam Surface. Each condition will be tested for 30 seconds, and the system will automatically calculate an overall composite sway score. Higher Sway Index shows lower sensory integration

    6 weeks

  • Functional Mobility

    The Timed Up and Go (TUG) test will be used to measure functional mobility before and after the intervention. Time to complete (in seconds) will be recorded using a stopwatch. Score ≤13.5 seconds is considered normal for community-dwelling older adults. Score \>13.5 seconds indicates reduced functional mobility

    6 weeks

Study Arms (2)

Otago Exercise Program

ACTIVE COMPARATOR

Strengthening exercises 1. Knee extensor (front knee strength) 2. Knee flexor (Back knee strength) 3. Hip abductor (side hip strength) 4. Ankle plantarflexors (calf raises) 5. Ankle dorsiflexors (toe raises) Balance retraining exercises 1\. Knee bends 2. Backwards walking 3. Walking and turning around 4. Sideways walking 5. Tandem stance (Heel toe stand) 6. Tandem walk (heel toe walk) 7. One leg stand 8. Heel walking 9. Toe walk 10. Heel toe walking backwards 11. sit to stand 12. Stair walking Levels: LEVEL A 10 repetitions Hold support LEVEL B 10 repetitions, no support or 10 repetitions, hold support, repeat LEVEL C 10 repetitions No support, repeat LEVEL D 3 x 10 repetitions No support

Procedure: Otago Exercise Program

Exergaming

EXPERIMENTAL

Games Included: 20,000 Leaks - multi-directional reaching, internal perturbations Reflex Ridge - anticipatory jumping, ducking, trunk-limb coordination River Rush - dynamic weight shifting, lateral stepping Rally Ball - anticipatory posture control, bilateral upper limb coordination Levels: Basic, Intermediate and Advance

Procedure: Exergaming

Interventions

It will consist of 5 Strengthening Exercises, 12 Progressive Balance Exercises and Walking Training (as tolerated). Protocol will include 3 sessions per week 30 minutes per session for total of 6 weeks Strength exercises will be progressed by increasing repetitions, weight, or duration. Balance tasks will be made challenging by reducing upper limb support, altering base of support, or eyes closing. Progression will be adjusted weekly based on performance and comfort. All sessions will be delivered under physiotherapist supervision using the official OEP manual.

Otago Exercise Program
ExergamingPROCEDURE

This intervention involves non-immersive exergaming using the Xbox Kinect system. Games Included are 20,000 Leaks, Reflex Ridge, River Rush and Rally Ball. Games will be played 3 times per week for 30 minutes for total of 6 weeks. Three difficulty levels include Basic, Intermediate and Advance. Progression based on participant performance, game scores (gold/silver pins, stars), and therapist observation. For first three weeks 2/3 Game Plays and last three weeks there will be 4/5 game plays. Sessions will be supervised one-on-one by a physiotherapist. Participant performance, fatigue, and safety will be monitored throughout the session.

Exergaming

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 55 years
  • Both Genders
  • Ambulatory, community-dwelling
  • Able to stand unassisted \>1 min
  • TUG ≤ 13.5 s
  • Able to understand and follow command

You may not qualify if:

  • Diagnosed vestibular and neurological conditions affecting balance
  • Orthopedic Conditions i.e., Recent fractures or surgeries, cervical spine issues or severe OA
  • Severe visual or auditory deficits
  • Use of Assistive device
  • Currently enrolled in any other balance or exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Mobility Limitation

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

December 15, 2025

First Posted

December 29, 2025

Study Start

November 18, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations