NCT06672354

Brief Summary

Falling is a serious concern for the growing elderly population due to age-related decline in physical function, leading to injuries, loss of independence, and a decline in overall well-being. The Otago Exercise Program (OEP), for the elderly consists of lower limb strengthening and balance exercises, leading to better strength, balance, and reduced fear of falling. The interactive and game-like nature of VR training can make it more engaging and motivating for older adults. It can provide challenging and engaging approach to exercise that can help to improve stability, enhance quality of life and reduce the risk of fall.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 31, 2024

Last Update Submit

October 31, 2024

Conditions

Keywords

ElderlyBalanceGaitVirtual Reality

Outcome Measures

Primary Outcomes (7)

  • Balance

    The Mini-BESTest includes 14 items that examine performance tasks related to dynamic balance. The test has a maximum score of 28 points from 14 items that are each scored from 0-2.

    12 weeks

  • Gait Speed

    he 10 Meter Walk Test, will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, gait speed will be evaluated based on the given formula: Distance walked/time(sec)

    12 weeks

  • Cycle Time

    The 10 Meter Walk Test, will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, cycle time will be evaluated based on the given formula: Time(sec) x 2 /No. of steps

    12 weeks

  • Stride Length

    The 10 Meter Walk Test, a performance measure will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, stride length will be evaluated based on the given formula: gait speed (m/s) x cycle time(sec)

    12 weeks

  • Cadence

    The 10 Meter Walk Test, a performance measure will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, cadence will be evaluated based on the given formula: No of steps x 60/time(sec)

    12 weeks

  • Leg Strength

    The 30 Second Sit to Stand Test will be used to test leg strength and endurance in older adults. The test stand involves recording the number of stands a person can complete in 30 seconds.

    12 weeks

  • Fear of Fall

    The Falls Efficacy Scale International, measure of "fear of falling" or "concerns about falling. It is a 16-item questionnaire, the item scores are summed up to obtain a total, with a score ranging from minimum 16 to maximum 64.

    12 weeks

Study Arms (2)

Otago Exercise Program Group

EXPERIMENTAL

It includes participants receiving Otago Exercise Program, which consists of stengthening, balance exercises and walking plan.

Procedure: Otago Exercise Program

Non-Immersive Virtual Reality Group

EXPERIMENTAL

This group involves participants receiving VR training exercises by using Xbox Kinect 360.

Procedure: Non-Immersive Virtual Reality Training

Interventions

1- Otago Exercise Program: i) This exercise program will consist of strengthening, balance exercises and walking plan. The OEP will be performed according to the following: 5 min warm-up, 10 min resistance training and 15 min balance exercises. ii) The strength training protocol targets, on hip abductors, knee flexors, knee extensors, plantarflexors, and dorsiflexors.All exercises will be performed for 10 repetitions. This protocol recommends strength training 3 days per week. iii) The balance retraining protocol incorporates various exercises. The exercises progress in difficulty through four levels, with Level 1 being the easiest and Level 4 the most challenging. Balance exercises will progress from holding onto a stable supporting structure such as heavy furniture to perform the exercises independent of the support. The protocol recommends participants to carry out balance exercises 3 days a week. iv) Participants will be instructed to walk at their usual pace for 30 minutes, twice

Otago Exercise Program Group

In this interventional group, VR training exercises will be performed by using Xbox Kinect, which includes a Kinect sensor.-The monitor or Tv screen will recognize the movements of participants via camera and infra-red motion sensors.-In order to perform simulated exercises in each session, the participant will be positioned at 1.5-2 meter from the monitor or TV screen.-The virtual reality training exercises will include Kinect Adventure games (Rally Ball, 20,000 leaks, Reflex Ridge) and Sports pack 1 games (Super Saver, Target Kick, Body ball).-Exercises will be continued for 30-45 minutes each session, for 3 alternate days per week for a total period of 12 weeks.

Non-Immersive Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

  • Age 55 years and above
  • Male and female both
  • Able to independently ambulate, without the assistance of a walking aid.
  • Participants that are able to maintain upright position with eyes open and eyes close for 10 seconds in standing position

You may not qualify if:

  • Wheel-chair bound elderly
  • Diagnosed with neurological disorder
  • Severe cognitive impairment (MMSE scoring of 17 or \<17)
  • Recent orthopedic trauma
  • Severe degenerative conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

RECRUITING

Central Study Contacts

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

October 31, 2024

First Posted

November 4, 2024

Study Start

June 20, 2024

Primary Completion

November 15, 2024

Study Completion

December 20, 2024

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations