NCT03656458

Brief Summary

Pakistan is a country devoid of health-care facilities and training programs on fall prevention. There is lack of research, awareness and implication of geriatric rehabilitation on elderly population addressing balance and fall risk assessment however very few cross-sectional studies of poor quality evidence are available on this issue. To best of investigators' knowledge, no interventional studies have been conducted in our country so far on this topic. . We aim to use a integrated method of balance training that uses patients judgment, visual feedback, proprioception and balance training with the help of new technology/devices to improve balance. And compare it to conventional treatment. We also aim to assess risk factors of fall in geriatric population, decreasing risks of falls and increasing awareness regarding geriatric rehabilitation and balance training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

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 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

August 13, 2018

Last Update Submit

August 30, 2018

Conditions

Fall

Keywords

Impaired BalanceGeriatricsBalance TrainingDynamic Stability TrainingFall RiskBerg Balance ScalePhysical TherapyForward Reach Test

Outcome Measures

Primary Outcomes (4)

  • Berg balance scale - Change is being assessed

    Pre-treatment (Base line), First Follow Up (2 weeks), Second Follow Up (4 weeks), Third Follow Up (6 weeks) and at Final Follow Up (8 weeks)

  • Quantitative measure of balance via Biodex balance system - Change is being assessed

    Pre-treatment (Base line), First Follow Up (2 weeks), Second Follow Up (4 weeks), Third Follow Up (6 weeks) and at Final Follow Up (8 weeks)

  • Forward reach test - Change is being assessed

    Pre-treatment (Base line), First Follow Up (2 weeks), Second Follow Up (4 weeks), Third Follow Up (6 weeks) and at Final Follow Up (8 weeks)

  • Timed Up and Go Test - Change is being assessed

    Pre-treatment (Base line), First Follow Up (2 weeks), Second Follow Up (4 weeks), Third Follow Up (6 weeks) and at Final Follow Up (8 weeks)

Study Arms (3)

Control Group A

ACTIVE COMPARATOR

Warm Up followed by Conventional Balance Training (Internal and External Perturbations)

Other: Warm UpOther: Conventional Balance Training

Control Group B

NO INTERVENTION

Control group. No intervention given to participants.

Experimental Group

EXPERIMENTAL

Warm Up followed by Biodex Balance Training

Other: Warm UpOther: Biodex Balance Training

Interventions

Warm UpOTHER

10 low jumps 5 Illiopoase Stretches 5 L/L Abductor Stretches 10 Trunk rotations 10 Should Circumduction Clock wise/Counter clockwise 10 Cervical Rotations Clockwise/Counter Clockwise

Control Group AExperimental Group
Conventional Balance TrainingOTHER

Internal Protuberances: 1. Looking up/Looking down/looking over the shoulder (Rt. /Lt.) 10 Reps Each 2. Looking behind over the shoulder (Rt. /Lt.)10 Reps 3. Looking Up with overhead Upper Limb Flexion. 5 Reps 4. Reaching out of Base of support (Rt. /Lt. / midline Cross) 10 Reps Each 5. Side to Side weight Shifting 10 Reps 6. Standing on toes/Heels 10 Reps each External Protuberance: 1. Tuck forward/ Backward/ Sideways(Rt. /Lt.) 10 reps Each 2. Bosu Ball Training

Control Group A
Biodex Balance TrainingOTHER

Biodex Balance Training Using Biodex Balance System SD

Experimental Group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals of age 60 -80 years
  • Both male and females

You may not qualify if:

  • Musculoskeletal conditions
  • Fractures
  • Severe arthritis
  • Neurological conditions
  • Epilepsy
  • Parkinson
  • Alzheimer's disease
  • Impaired cognition
  • Other systemic diseases or co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

Location

Related Publications (7)

  • Mancini M, Horak FB. The relevance of clinical balance assessment tools to differentiate balance deficits. Eur J Phys Rehabil Med. 2010 Jun;46(2):239-48.

    PMID: 20485226BACKGROUND

  • Sibley KM, Straus SE, Inness EL, Salbach NM, Jaglal SB. Balance assessment practices and use of standardized balance measures among Ontario physical therapists. Phys Ther. 2011 Nov;91(11):1583-91. doi: 10.2522/ptj.20110063. Epub 2011 Aug 25.

    PMID: 21868613BACKGROUND

  • Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.

    PMID: 23523272BACKGROUND

  • Tinetti ME, Kumar C. The patient who falls: "It's always a trade-off". JAMA. 2010 Jan 20;303(3):258-66. doi: 10.1001/jama.2009.2024.

    PMID: 20085954BACKGROUND

  • Geiger RA, Allen JB, O'Keefe J, Hicks RR. Balance and mobility following stroke: effects of physical therapy interventions with and without biofeedback/forceplate training. Phys Ther. 2001 Apr;81(4):995-1005.

    PMID: 11276182BACKGROUND

  • Schoene D, Valenzuela T, Lord SR, de Bruin ED. The effect of interactive cognitive-motor training in reducing fall risk in older people: a systematic review. BMC Geriatr. 2014 Sep 20;14:107. doi: 10.1186/1471-2318-14-107.

    PMID: 25240384BACKGROUND

  • Schwenk M, Grewal GS, Honarvar B, Schwenk S, Mohler J, Khalsa DS, Najafi B. Interactive balance training integrating sensor-based visual feedback of movement performance: a pilot study in older adults. J Neuroeng Rehabil. 2014 Dec 13;11:164. doi: 10.1186/1743-0003-11-164.

    PMID: 25496052BACKGROUND

MeSH Terms

Interventions

Warm-Up Exercise

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Furqan Ahmed Siddiqi, BSPT, PP-DPT, PhD

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor was not aware regarding the allocation of participants to study groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean (Academics) FUIRS

Study Record Dates

First Submitted

August 13, 2018

First Posted

September 4, 2018

Study Start

March 1, 2016

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

September 4, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)