NCT05060042

Brief Summary

The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and proprioceptive training through Tai Chi program on static and dynamic postural balance variables of the elderly population. The purpose of the study is to determine that whether whole body vibrator is more evident or proprioceptive training is more effective for promoting functional independency and improving balance in older adults. Hence distinguishing choices to prevent fall and advancing functional independency by using the appropriate intervention without using extreme loads.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

September 17, 2021

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time up and go test

    The assessment of functional mobility in community dwelling elderly population, is assessed precisely by a balance test called time up and go test.Time taken to complete the task is actually indicating the level of functional mobility. An elder participant taking less than 20 seconds to complete the task have been shown to be independent in ADLs. Time taken more than 30 seconds by an older subject, indicates more dependent in ADLs and requires assistive devices for ambulation.

    Change from Baseline balance to 8th Weeks

  • Performance-Oriented Mobility Assessment (POMA):

    • The Tinetti Performance Oriented Mobility Assessment (POMA) is a widely used clinical assessment tool that gives an insight into the abnormalities in balance and gait, and it has the ability to predict fall risk in elderly population.• This scale has a total maximum score of 28 in which there is 12 score of gait assessment and 16 score of balance assessment. The overall score of 25-28 indicates low fall risk, 19-24 represents moderate fall risk and \<19 means there is high risk of fall in suspected elderly population. This scale has been declared has a valid and reliable tool to assess balance and gait impairments

    Change from Baseline balance and gait to 8th Weeks

Study Arms (2)

Whole body vibration group

EXPERIMENTAL

WBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week.

Other: Whole body vibration group

Bilateral proprioceptive training Group

ACTIVE COMPARATOR

Static balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints. In 4th week progressive balance training will be done with same frequency and duration. Tai chai exercises will be given for 20 mints 3 times a week

Other: Bilateral proprioceptive training

Interventions

WBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week

Whole body vibration group

Static balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints. In 4th week progressive balance training will be done with same frequency and duration. Tai chai exercises will be given for 20 mints 3 times a week

Bilateral proprioceptive training Group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with balance and proprioception problems
  • Those having BBS score between 21-54
  • Intact cognition: MMSE \>25

You may not qualify if:

  • Subjects with recent trauma or any other neurodegenerative disorder.
  • Subjects with cognitive and hearing impairments
  • Subjects who cannot follow my command.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Misbah Ghous

Rawalpindi, Islamabad, 46000, Pakistan

Location

Pakistan General Railway Hospital

Rawalpindi, Islamabad, 46000, Pakistan

Location

Study Officials

  • Misbah ghous, MS

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

October 1, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations