- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656458
Effects of Balance Training on Fall Risk and Mobility in the Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Balance is use of multiple systems of the body including auditory, motor, visual, vestibular and nervous to keep body staying inside limits of stability. It includes maintaining posture under different conditions in standing or sitting, ability to facilitate movement and to recover and stay in limits of stability after external (Trip, push, slip) and internal (body movements) protuberance. Impaired balancing system of body results in increased risk of fall which is major cause of mortality and morbidity in geriatric population.
A report of 2014 stated that Pakistan has 12.13 million population of Age 60 years and above which is expected to rise to 17.53 Million by year 2025. According to a study 30-50 % of population of age 65 years and above have some problems with balance. Another study states that 75 % of people aging 70 years and above have balance impairments which leads to fall. Additionally number of conditions including poly pharmacy, female gender, visual problems, environmental problems and cognitive issue contribute to in fall risk and balance problems. One of the major goal of Balance re-education is to decrease fall risk. Literature has suggested that one of the most effective methods of reducing falls in geriatric population is to prophylactically intervene on multiple risks factors of fall. This includes outpatient balance training and fall risk assessment.
Force plate systems and mirrors which are the part of visual biofeedback are often used for treatment of balance disorders but are found to have no difference in educating compared to conventional management. In current era technology has advances to a great extend and new systems that quantifies balance and provide a reliable and valid data regarding balance which then can be used in formation of balance training plan. These systems can also be used for treatment purposes and also have various visual feedback systems for more educational benefits. One of these systems is Biodex balance system which is used for balance and postural reduction, increase proprioception, somatosensory and neuromuscular control. It incorporates patient data saving and printing system for record management and uses an integrated system which involves patient in activities of re-education with relation to visual feedback to accommodate body accordingly.
As mentioned earlier Falls result in high morbidity and mortality among geriatric population which leads to increased costs and need for rehabilitation services. Falls are brought about by detrimental effects of aging on postural control as a result of deterioration in neuromuscular and sensory mechanisms, physical inactivity, pre-existing pathology and use of medications. However, balance training and exercise interventions tend to decrease risk of falling and eventually fall itself. Moreover, conventional balance training programs have decreased adherence; hence, sensor-based training programs have been advocated. These programs have quiet good advantages including visual feedback with interactive environment and targeted interventions. This exercise system incorporates human-computer interface providing a three-dimensional and real-time feedback.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan, 46000
- Foundation University Islamabad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals of age 60 -80 years
- Both male and females
Exclusion Criteria:
Musculoskeletal conditions
- Fractures
- Severe arthritis
Neurological conditions
- Epilepsy
- Parkinson
- Alzheimer's disease
- Impaired cognition
- Other systemic diseases or co-morbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control Group A
Warm Up followed by Conventional Balance Training (Internal and External Perturbations)
|
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
Internal Protuberances:
External Protuberance:
|
NO_INTERVENTION: Control Group B
Control group.
No intervention given to participants.
|
|
EXPERIMENTAL: Experimental Group
Warm Up followed by Biodex Balance Training
|
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
Biodex Balance Training Using Biodex Balance System SD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Berg balance scale - Change is being assessed
Time Frame: 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)
|
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
Time Frame: 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)
|
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
Time Frame: 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)
|
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
Time Frame: 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)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Furqan Ahmed Siddiqi, BSPT, PP-DPT, PhD, Foundation University Islamabad
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FUI/CTR/2018/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fall
-
University of AmsterdamCompletedDeprescribing | Fall | Fall Injury | Fall Patients | Accidental FallNetherlands
-
University of Illinois at Urbana-ChampaignUnknownFall Injury | Fall Prevention | Fall Safety
-
University of ArizonaVirginia Polytechnic Institute and State UniversityNot yet recruiting
-
Neuroscience Research AustraliaThe University of New South WalesCompleted
-
Aalborg University HospitalCompleted
-
Academisch Medisch Centrum - Universiteit van Amsterdam...VU University of AmsterdamNot yet recruitingFall | Aged | Fall Injury | Fall Patients | Polypharmacy | Accidental Fall | Aged, 80 and Over | DeprescriptionsNetherlands
-
Dalarna UniversitySormland County Council, SwedenRecruiting
-
University of PotsdamSwiss Council for Accident Prevention; Prof. Dr. Reto W. Kressig and Dr. Yves...CompletedFall Prevention | Fall Risk FactorsGermany
-
Leon BrüllHumboldt-Universität zu BerlinTerminatedFall Risk, Fall PreventionGermany
-
MedicusTek, IncCompletedPatient Fall | Accidental Fall From BedTaiwan
Clinical Trials on Warm Up
-
Opti'MouvUniversité Grenoble-AlpesCompleted
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
University of PortsmouthTerminatedChronic Obstructive Pulmonary DiseaseUnited Kingdom
-
Universidade Federal do Rio Grande do NorteCompletedNeuromuscular Manifestations
-
University of Erlangen-NürnbergCompletedPostural BalanceGermany
-
University of the State of Santa CatarinaCompletedHip Adduction | Gluteus EMG ActivityBrazil
-
Cardenal Herrera UniversityRecruiting
-
Paulista UniversityRecruiting
-
University of ExtremaduraLuis Espejo AntúnezCompleted
-
University of ManitobaCompletedInjury of Anterior Cruciate LigamentCanada