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

NCT ID: NCT03656458

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-02-15

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.

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.

Conditions

Fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group A

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

Group Type: ACTIVE_COMPARATOR

Warm Up

Intervention Type: OTHER

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

Conventional Balance Training

Intervention Type: OTHER

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 B

Control group. No intervention given to participants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group

Warm Up followed by Biodex Balance Training

Group Type: EXPERIMENTAL

Warm Up

Intervention Type: OTHER

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

Intervention Type: OTHER

Biodex Balance Training Using Biodex Balance System SD

Interventions

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

Intervention Type: OTHER

Conventional Balance Training

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

Intervention Type: OTHER

Biodex Balance Training

Biodex Balance Training Using Biodex Balance System SD

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Furqan Ahmed Siddiqi

Associate Dean (Academics) FUIRS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Furqan Ahmed Siddiqi, BSPT, PP-DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Foundation University Islamabad

Locations

Foundation University Islamabad

Islamabad, Federal, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

PMID: 20485226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21868613 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23523272 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20085954 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11276182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25240384 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25496052 (View on PubMed)

Other Identifiers

FUI/CTR/2018/1

Identifier Type: -

Identifier Source: org_study_id