NCT04824196

Brief Summary

Background/Objective: The aim of this study was to compare the effects of vestibular visual cues and propriception to improve postural control in elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 28, 2021

Last Update Submit

March 29, 2021

Conditions

Keywords

Postural controlProprioceptionVestibularElderlyBBSCTSIB

Outcome Measures

Primary Outcomes (2)

  • Berg balance scale

    The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities, named after Katherine Berg, one of the developers. For functional balance tests, the BBS is generally considered to be the gold standard.\[3\] The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores

    2 months

  • Clinical test of sensory organization and balance (CTSIB

    nical Test of Sensory Interaction and Balance (CTSIB) is a tool that assesses a person's ability to use sensory inputs for balance. The original test included 6 conditions: (1) standing with eyes open on a firm surface, (2) standing with eyes closed on a firm surface, (3) standing with a visual conflict dome on a firm surface, (4)

    2 months

Study Arms (2)

vestibular visual cues therapy

EXPERIMENTAL

Pelvic rolling to right and left with head movement and stop first on right side for 3 minutes. Do this exercise in front of the mirror.Anterior, posterior, left, and right rectilinear stimulation activities on a therapeutic ball. Anterior, posterior, left and right rectilinear movements were performed for five minutes

Other: vestibular visual cues therapy

propriocetion therapy

ACTIVE COMPARATOR

Alternate knee flexion-extension with extended trunk posture using both hands for support. Hip and knee flexion-extension with swiss ball between the back and wall. Hip aises lying with their back on the floor with both legs on the swiss ball. Upper limbs leaning on the floor to help with the exercises. then perform all exercise on gym ball

Other: propriocetion exercise

Interventions

Pelvic rolling to right and left with head movement and stop first on right side for 3 minutes. Do this exercise in front of the mirrorAnterior, posterior, left, and right rectilinear stimulation activities on a therapeutic ball. Anterior, posterior, left and right rectilinear

vestibular visual cues therapy

1. Alternate knee flexion-extension with extended trunk posture using both hands for support. 2. Hip and knee flexion-extension with swiss ball between the back and wall. 3. Hip raises lying with their back on the floor with both legs on the swiss ball. Upper limbs leaning on the floor to help with the exercises. then all exercise are perfomed on gym ball

propriocetion therapy

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance.
  • Able to follow simple directions, for example, left, right, up, or down.
  • Either using visual aids.
  • Fakuda test for screening.
  • VOR reflex for screening

You may not qualify if:

  • Presence of orthopedic problems.
  • Neurological disorders.
  • Psychological problems.
  • Cognitive issues.
  • People with severe visual issues
  • Participants with other medical complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Martins E Silva DC, Bastos VH, de Oliveira Sanchez M, Nunes MK, Orsini M, Ribeiro P, Velasques B, Teixeira SS. Effects of vestibular rehabilitation in the elderly: a systematic review. Aging Clin Exp Res. 2016 Aug;28(4):599-606. doi: 10.1007/s40520-015-0479-0. Epub 2015 Oct 28.

    PMID: 26511625BACKGROUND
  • Kleffelgaard I, Soberg HL, Tamber AL, Bruusgaard KA, Pripp AH, Sandhaug M, Langhammer B. The effects of vestibular rehabilitation on dizziness and balance problems in patients after traumatic brain injury: a randomized controlled trial. Clin Rehabil. 2019 Jan;33(1):74-84. doi: 10.1177/0269215518791274. Epub 2018 Jul 30.

    PMID: 30056743BACKGROUND
  • Ribeiro KM, Freitas RV, Ferreira LM, Deshpande N, Guerra RO. Effects of balance Vestibular Rehabilitation Therapy in elderly with Benign Paroxysmal Positional Vertigo: a randomized controlled trial. Disabil Rehabil. 2017 Jun;39(12):1198-1206. doi: 10.1080/09638288.2016.1190870. Epub 2016 Jun 24.

    PMID: 27340939BACKGROUND
  • Rossi-Izquierdo M, Gayoso-Diz P, Santos-Perez S, Del-Rio-Valeiras M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Lirola-Delgado A, Soto-Varela A. Vestibular rehabilitation in elderly patients with postural instability: reducing the number of falls-a randomized clinical trial. Aging Clin Exp Res. 2018 Nov;30(11):1353-1361. doi: 10.1007/s40520-018-1003-0. Epub 2018 Jul 14.

    PMID: 30008159BACKGROUND
  • Ricci NA, Aratani MC, Caovilla HH, Gananca FF. Effects of Vestibular Rehabilitation on Balance Control in Older People with Chronic Dizziness: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2016 Apr;95(4):256-69. doi: 10.1097/PHM.0000000000000370.

    PMID: 26368833BACKGROUND
  • Tramontano M, Martino Cinnera A, Manzari L, Tozzi FF, Caltagirone C, Morone G, Pompa A, Grasso MG. Vestibular rehabilitation has positive effects on balance, fatigue and activities of daily living in highly disabled multiple sclerosis people: A preliminary randomized controlled trial. Restor Neurol Neurosci. 2018;36(6):709-718. doi: 10.3233/RNN-180850.

    PMID: 30412513BACKGROUND
  • Hebert JR, Corboy JR, Manago MM, Schenkman M. Effects of vestibular rehabilitation on multiple sclerosis-related fatigue and upright postural control: a randomized controlled trial. Phys Ther. 2011 Aug;91(8):1166-83. doi: 10.2522/ptj.20100399. Epub 2011 Jun 16.

    PMID: 21680771BACKGROUND
  • Jahn K. The Aging Vestibular System: Dizziness and Imbalance in the Elderly. Adv Otorhinolaryngol. 2019;82:143-149. doi: 10.1159/000490283. Epub 2019 Jan 15.

    PMID: 30947233BACKGROUND
  • Eibling D. Balance Disorders in Older Adults. Clin Geriatr Med. 2018 May;34(2):175-181. doi: 10.1016/j.cger.2018.01.002. Epub 2018 Feb 24.

    PMID: 29661330BACKGROUND
  • Melo RS, Lemos A, Paiva GS, Ithamar L, Lima MC, Eickmann SH, Ferraz KM, Belian RB. Vestibular rehabilitation exercises programs to improve the postural control, balance and gait of children with sensorineural hearing loss: A systematic review. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109650. doi: 10.1016/j.ijporl.2019.109650. Epub 2019 Aug 21.

    PMID: 31466025BACKGROUND

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 1, 2021

Study Start

March 15, 2020

Primary Completion

November 20, 2020

Study Completion

December 30, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations