NCT04994678

Brief Summary

People worldwide are living longer. Today, for the first time in history, most people can expect to live into their sixties and beyond. By 2050, the world's population aged 60 years and older is expected to total 2 billion, up from 900 million in 2015. Today, 125 million people are aged 80 years or older. By 2050, there will be almost this many (120 million) living in China alone, and 434 million people in this age group worldwide. By 2050, 80% of all older people will live in low- and middle-income countries. As we age, we lose balance function through loss of sensory elements, the ability to integrate information and issue motor commands, and because we lose musculoskeletal function. Diseases common in aging populations lead to further deterioration in balance function in some patients. study aims to determine the Effect of Virtual Reality exercise regimen on postural stability and gait dynamics in elderly population. By obtaining these results we can recommend and effective balance training regime which can be implemented in health care system and hence resulting in decrease fall events in geriatric population and also reduce fall related health care financial burden on economy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 3, 2021

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postural Stability Assessment

    Postural stability assessment will be done via use of Biodex balance system SD.

    6 weeks

  • Gait Parameters

    Spatial and temporal Gait Parameters including step width, step length, stride length, cadence.

    6 weeks

Secondary Outcomes (3)

  • Mobility

    6 weeks

  • Functional Lower Extremity Strength

    6 weeks

  • Aerobic capacity

    6 weeks

Study Arms (2)

Virtual Reality Training Group

EXPERIMENTAL

VR training system will be setup in multidisciplinary lab of Foundation University Institute of Rehabilitation Sciences Foundation University Islamabad. Display will be provided on 55 inch LED TV with audio feedback. Display will be at height of 5 feet from floor and at distance of 6 feet from Subject. The Virtual reality based training group will receive a game based virtual reality training via XBOX 360 or wii fit balance games. Particiapants will be required to physically move to move avatar on screen to rapidly leaning away, squat to avoid overhead obstacles and try small jump to avoid lower obstacles, single leg stance, in addition person will required to do half squatting, side to side jumps and vertical jumps. Treatment will be provided 3 times a week for 6 weeks with each session lasting for 30-50 minutes. Progressively challenge will be increased.

Other: Virtual Reality Training

Moderate Aerobic Exercise Training Group

ACTIVE COMPARATOR

Moderate aerobic exercise training will be provided using motorized tread mill and stationary/recombinent cycle. Treatment will be provided for 30-50 minutes 3 times a week for 6 weeks.

Other: Moderate Aerobic Exercise Training

Interventions

The Virtual reality based training group will receive a game based virtual reality training via XBOX 360or wii fit balance games. Player will be required to rapidly leaning away, squat to avoid overhead obstacles and try small jump to avoid lower obstacles, single leg stance, in addition person will required to do half squatting, side to side jumps and vertical jumps. Treatment will be provided 3 times a week or 6 weeks with each session lasting for 30-50 minutes. Progressively challenge will be increased.

Virtual Reality Training Group

Moderate intensity continuous Aerobic exercises (Recombinant/Stationary cycling for 10-15 min with progression followed by treadmill walking for 10-15 min with progression, as well as stepping and Jogging). The session will be preceded by 5-7 minute warm-up \& 7-10 min cool-down.

Moderate Aerobic Exercise Training Group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly Population the age of 55 Years
  • Either Gender

You may not qualify if:

  • Severe orthopedic, cardiovascular pulmonary disease.
  • History of Surgery \& Severe Trauma of Lower extremity.
  • Other musculoskeletal Disorders (Scoliosis \& Lordosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

RECRUITING

Study Officials

  • Muhammad Ehab Azim

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Ehab Azim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blinded study with random allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to interventional group (virtual Reality Training Group) and Control Group (Aerobic Training Group) for whole duration of study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 6, 2021

Study Start

June 15, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations