Effects of Balance Training on Fall Risk and Mobility in the Elderly

• ClinicalTrials.gov Identifier: NCT03656458
• Recruitment Status: Completed
• First Posted: September 4, 2018
• Last Update Posted: September 4, 2018
• Sponsor: Foundation University Islamabad
• Information provided by (Responsible Party): Furqan Ahmed Siddiqi, Foundation University Islamabad

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fall	Other: Warm Up; Other: Conventional Balance Training; Other: Biodex Balance Training	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcomes assessor was not aware regarding the allocation of participants to study groups.
• Primary Purpose: Prevention
• Official Title: Effects of Balance Training on Fall Risk and Mobility in the Elderly
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: February 15, 2017
• Actual Study Completion Date: February 15, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control Group A; Warm Up followed by Conventional Balance Training (Internal and External Perturbations)	Other: Warm Up; 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; Other: Conventional Balance Training; Internal Protuberances: Looking up/Looking down/looking over the shoulder (Rt. /Lt.) 10 Reps Each; Looking behind over the shoulder (Rt. /Lt.)10 Reps; Looking Up with overhead Upper Limb Flexion. 5 Reps; Reaching out of Base of support (Rt. /Lt. / midline Cross) 10 Reps Each; Side to Side weight Shifting 10 Reps; Standing on toes/Heels 10 Reps each External Protuberance: Tuck forward/ Backward/ Sideways(Rt. /Lt.) 10 reps Each; Bosu Ball Training
No Intervention: Control Group B; Control group. No intervention given to participants.
Experimental: Experimental Group; Warm Up followed by Biodex Balance Training	Other: Warm Up; 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; Other: Biodex Balance Training; Biodex Balance Training Using Biodex Balance System SD

Outcome Measures

Primary Outcome Measures :

1. 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) ]
2. 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) ]
3. 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) ]
4. 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) ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Pakistan

Foundation University Islamabad

Islamabad, Federal, Pakistan, 46000

Sponsors and Collaborators

Foundation University Islamabad

Investigators

• Principal Investigator: Furqan Ahmed Siddiqi, BSPT, PP-DPT, PhD; Foundation University Islamabad

More Information

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. Review.

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. Review.

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. Review.

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.

• Responsible Party: Furqan Ahmed Siddiqi, Associate Dean (Academics) FUIRS, Foundation University Islamabad
• ClinicalTrials.gov Identifier: NCT03656458
• Other Study ID Numbers: FUI/CTR/2018/1
• First Posted: September 4, 2018
• Last Update Posted: September 4, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Furqan Ahmed Siddiqi, Foundation University Islamabad:

Impaired Balance; Geriatrics; Balance Training; Dynamic Stability Training; Fall Risk; Berg Balance Scale; Physical Therapy; Forward Reach Test