FallNCT03656458
Effects of Balance Training on Fall Risk and Mobility in the Elderly
A study testing Warm Up, Conventional Balance Training and Biodex Balance Training in people with Fall, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Warm Up, Conventional Balance Training and Biodex Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2016to 15 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals of age 60 -80 years
- Both male and females
Who cannot join
- Musculoskeletal conditions
- Fractures
- Severe arthritis
- Neurological conditions
- Epilepsy
- Parkinson
Show all 9Show fewer
- Alzheimer's disease
- Impaired cognition
- Other systemic diseases or co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Warm Up, Conventional Balance Training, Biodex Balance Training
- Keywords
- Impaired Balance, Geriatrics, Balance Training, Dynamic Stability Training, Fall Risk, Berg Balance Scale, Physical Therapy, Forward Reach Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Conventional Balance TrainingOther
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
Biodex Balance TrainingOther
Biodex Balance Training Using Biodex Balance System SD
| Study group | Role | What they receive |
|---|---|---|
| Control Group A | Active comparator | Warm Up followed by Conventional Balance Training (Internal and External Perturbations) Receives: Other: Warm Up; Other: 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 Receives: Other: Warm Up; Other: Biodex Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale - Change is being assessed
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study startMar 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furqan Ahmed Siddiqi, Foundation University Islamabad
- Investigators
- Furqan Ahmed Siddiqi, BSPT, PP-DPT, PhD, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656458
- Sponsor's protocol ID
- FUI/CTR/2018/1
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20485226Sibley 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.
PubMed 21868613Ambrose 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.
PubMed 23523272Tinetti 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.
PubMed 20085954Geiger 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.
PubMed 11276182Schoene 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.
PubMed 25240384Schwenk 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.
PubMed 25496052
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Training on Fall Risk and Mobility in the Elderly
- ClinicalTrials.gov ID
- NCT03656458
- Acronym / sponsor ID
- FUI/CTR/2018/1
- Conditions
- Fall
- Keywords
- Impaired Balance, Geriatrics, Balance Training, Dynamic Stability Training, Fall Risk, Berg Balance Scale, Physical Therapy, Forward Reach Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group A | Active comparator | Other: Warm Up, Other: Conventional Balance TrainingWarm Up followed by Conventional Balance Training (Internal and External Perturbations) |
| Control Group B | No intervention | –Control group. No intervention given to participants. |
| Experimental Group | Experimental | Other: Warm Up, Other: Biodex Balance TrainingWarm Up followed by Biodex Balance Training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals of age 60 -80 years
- Both male and females
Key exclusion criteria (9 listed)
- Musculoskeletal conditions
- Neurological conditions
- Other systemic diseases or co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm Up10 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 | Control Group A, Experimental Group |
| Conventional Balance TrainingInternal 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 | Other | Control Group A |
| Biodex Balance TrainingBiodex Balance Training Using Biodex Balance System SD | Other | Experimental Group |
Primary outcome
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Background: PubMed 20485226Mancini 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.
- Background: PubMed 21868613Sibley 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.
- Background: PubMed 23523272Ambrose 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.
- Background: PubMed 20085954Tinetti 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.
- Background: PubMed 11276182Geiger 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.
- Background: PubMed 25240384Schoene 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.
- Background: PubMed 25496052Schwenk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Furqan Ahmed Siddiqi, BSPT, PP-DPT, PhD principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Up, Conventional Balance Training and Biodex Balance Training in people with Fall, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656458, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.