Balance; DistortedNCT05086211
PNFand Perturbations Based Exercises on Balance Training in Elder Population
A study testing proprioceptive neuromuscular facilitation and pertubation based balance training in people with Balance; Distorted, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of proprioceptive neuromuscular facilitation techniques and perturbation-based balance training on risk of falls and quality of life in elderly population.65 to 85 years old age both male and female participants experienced fall greater than1 time in last 1 year is included in this study.Two… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- proprioceptive neuromuscular facilitation and pertubation based balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jun 2021to 15 Aug 2022
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years - 85 years of age
- Gender: Both Male and Female
- Participants experienced fall >1 time in last 1 year.
- Patients should stand independently without upper limb support for >30s.
- Participants should tolerate at least 10 postural perturbations.
Who cannot join
- Participants with body weight > 100kgs.
- Participants with lower extremity amputation.
- Severe osteoporosis
- Having recent illness, surgery, cognitive impairment or another neurological deficit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of PNF Techniques and Perturbation Based Balance Training on Risk of Fall and Quality of Life in Elderly Population
To compare the effects of proprioceptive neuromuscular facilitation techniques and perturbation-based balance training on risk of falls and quality of life in elderly population.65 to 85 years old age both male and female participants experienced fall greater than1 time in last 1 year is included in this study.Two groups in this study group A will receive proprioceptive neuromuscular facilitation techniques and group B will receive pertubations based balance training.berg balance scale,time up and go test quality of life scale and Modified John Hopkins Fall Risk Assessment Tool will be used for pre and post assessment.
Read the detailed description
Balance is very crucial component for living an independent life among older adults and performing their daily life activities independently. Balance control provides foundation to move and perform daily life functions.balance control deteriorates with age, and balance impairment is a major risk of fall among older adults. Fall may result in severe injuries, fracture, causing severe longstanding pain, low quality of life, disability or death. In older adults, falls most commonly result in many co-morbidities and mortality. The proprioceptive Neuromuscular Facilitation is greatly used technique as an intervention for neuromuscular dysfunction. By applying PNF technique, therapist can improve movement re-education.this technique help in improving muscle strengthening and stabilization. PNF technique uses reflexes of nervous system that help to relax a muscle.proprioceptive neuromuscular facilitation (PNF) promotes strengthening, motor learning and restoration of motor control in elderly individuals despite of neuromuscular and deficits.The Perturbation-based balance training comprises of some unpredictable, multi-directional dynamic-platform perturbations to elicit stepping and grasping reactions. The extent of perturbations is gradually improved over the period of program. The perturbation-based balance training program can help to improve or reverse impairments associated with older age in balance-recovery reactions. This program will greatly help in preventing falls, which may lead to improved health, enhanced mobility, more independence and high quality of life. Increased frequency of collisions are shown by older adults in swing phase and stance leg. Moreover, step length is also reduced and the frequency of multiple-step responses is increased. Older individuals rely more upon arm reactions to recover balance but the speed tends to decrease while initiation and execution of grasping reaction. And all reactions mentioned above are associated with increased risk of falling. The perturbation-based training program promote effective change in support program reactions that may help to reduce risk of falls and this training program should be part of fall prevention program and thus helping in improved quality of life
- Conditions
- Balance; Distorted
- Being tested
- proprioceptive neuromuscular facilitation, pertubation based balance training
- Keywords
- proprioceptive neuromuscular facilitations, pertubation based balance training, elder population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive neuromuscular facilitationOther
Each session including three proprioceptive neuromuscular facilitation techniques:
Balance training exercises,participants will be treated for 20 minutes with PNF techniques that included;Rhythmic initiation, slow reversal techniques practiced with D1 and D2 pattern in lower limb,repeated contraction and Resisted PNF.The Technique will be performed for 3 days per week in same order on all subjects.
pertubation based balance trainingOther
Each session will include a 5-10min warm-up,voluntary tasks intended to induce internal perturbations,voluntary tasks combined with external perturbations and a 5-10mins cool down.The technique will be performed for 2 sets of 10 repetitions on all subjects
| Study group | Role | What they receive |
|---|---|---|
| proprioceptive neuromuscular facilitation | Experimental | Each session including three PNF techniques:
Balance training exercises,participants will be treated for 20 minutes with PNF techniques that included;Rhythmic initiation, slow reversal techniques practiced with D1 and D2 pattern in lower limb,repeated contraction and Resisted PNF.The Technique will be performed for 3 days per week in same order on all subjects. Receives: Other: proprioceptive neuromuscular facilitation |
| pertubation based balance training | Experimental | Each session will include a 5-10min warm-up,voluntary tasks intended to induce internal perturbations,voluntary tasks combined with external perturbations and a 5-10mins cool down.The technique will be performed for 2 sets of 10 repetitions on all subjects. Receives: Other: pertubation based balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
berg balance scale
Berg Balance Scale is the gold standard scale for assessment of Static and Dynamic Balance of a person. It is widely used in clinical settings. It consists of 14 balance related tasks. If a person performs the task independently it means a score of 4 and if a person is unable to do a task then a score of 0 is given. The sum of all the scores at the end will give us a final measure. It is a valid and reliable tool.
Measured: week 6
Secondary outcomes (3)
Time up and Go Test
it is a test used to assess the mobility of an individual. It requires the assessment of both static and dynamic balance. It is a reliable and valid tool.
Measured: week 6
Quality of life Scale
It is a 16-item scale used to assess the quality of life. It is internally consistent (a=0.82 to 0.92 with a test-retest reliability of r=0.78 to 0.84)
Measured: week 6
Modified John Hopkins Fall Risk Assessment Tool
This is a simple tool used for assessment of risk of fall in older adults. It is a multifactor tool with promising sensitivity and specificity. It consists of 7 components. Its Inter-rater reliability is 85.7%
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start26 Jun 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Balance; DistortedStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sania Aziz, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086211
- Sponsor's protocol ID
- Syeda Maria nazir
- Status last verified
- May 2024
- First submitted
- 19 Oct 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halvarsson A, Dohrn IM, Stahle A. Taking balance training for older adults one step further: the rationale for and a description of a proven balance training programme. Clin Rehabil. 2015 May;29(5):417-25. doi: 10.1177/0269215514546770. Epub 2014 Sep 8.
PubMed 25200877Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.
PubMed 17540020Guirguis-Blake JM, Michael YL, Perdue LA, Coppola EL, Beil TL. Interventions to Prevent Falls in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Apr 24;319(16):1705-1716. doi: 10.1001/jama.2017.21962.
PubMed 29710140Beling J, Roller M. Multifactorial intervention with balance training as a core component among fall-prone older adults. J Geriatr Phys Ther. 2009;32(3):125-33. doi: 10.1519/00139143-200932030-00008.
PubMed 20128337Dunsky A. The Effect of Balance and Coordination Exercises on Quality of Life in Older Adults: A Mini-Review. Front Aging Neurosci. 2019 Nov 15;11:318. doi: 10.3389/fnagi.2019.00318. eCollection 2019.
PubMed 31803048Heydarnejad S, Dehkordi AH. The effect of an exercise program on the health-quality of life in older adults. A randomized controlled trial. Dan Med Bull. 2010 Jan;57(1):A4113.
PubMed 20175947You H, Zhang H, Liu J, Han T, Zhang M, Zhao W, Jiang S. Effect of balance training with Pro-kin System on balance in patients with white matter lesions. Medicine (Baltimore). 2017 Dec;96(51):e9057. doi: 10.1097/MD.0000000000009057.
PubMed 29390433Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.
PubMed 23023812Hnizdo S, Archuleta RA, Taylor B, Kim SC. Validity and reliability of the modified John Hopkins Fall Risk Assessment Tool for elderly patients in home health care. Geriatr Nurs. 2013 Sep-Oct;34(5):423-7. doi: 10.1016/j.gerinurse.2013.05.011. Epub 2013 Jun 29.
PubMed 23816376Seo KC, Kim HA. The effects of ramp gait exercise with PNF on stroke patients' dynamic balance. J Phys Ther Sci. 2015 Jun;27(6):1747-9. doi: 10.1589/jpts.27.1747. Epub 2015 Jun 30.
PubMed 26180312
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of PNF Techniques and Perturbation Based Balance Training on Risk of Fall and Quality of Life in Elderly Population
- ClinicalTrials.gov ID
- NCT05086211
- Acronym / sponsor ID
- Syeda Maria nazir
- Conditions
- Balance; Distorted
- Keywords
- proprioceptive neuromuscular facilitations, pertubation based balance training, elder population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 20 Oct 2021 (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.
To compare the effects of proprioceptive neuromuscular facilitation techniques and perturbation-based balance training on risk of falls and quality of life in elderly population.65 to 85 years old age both male and female participants experienced fall greater than1 time in last 1 year is included in this study.Two groups in this study group A will receive proprioceptive neuromuscular facilitation techniques and group B will receive pertubations based balance training.berg balance scale,time up and go test quality of life scale and Modified John Hopkins Fall Risk Assessment Tool will be used for pre and post assessment.
Detailed description
Balance is very crucial component for living an independent life among older adults and performing their daily life activities independently. Balance control provides foundation to move and perform daily life functions.balance control deteriorates with age, and balance impairment is a major risk of fall among older adults. Fall may result in severe injuries, fracture, causing severe longstanding pain, low quality of life, disability or death. In older adults, falls most commonly result in many co-morbidities and mortality. The proprioceptive Neuromuscular Facilitation is greatly used technique as an intervention for neuromuscular dysfunction. By applying PNF technique, therapist can improve movement re-education.this technique help in improving muscle strengthening and stabilization. PNF technique uses reflexes of nervous system that help to relax a muscle.proprioceptive neuromuscular facilitation (PNF) promotes strengthening, motor learning and restoration of motor control in elderly individuals despite of neuromuscular and deficits.The Perturbation-based balance training comprises of some unpredictable, multi-directional dynamic-platform perturbations to elicit stepping and grasping reactions. The extent of perturbations is gradually improved over the period of program. The perturbation-based balance training program can help to improve or reverse impairments associated with older age in balance-recovery reactions. This program will greatly help in preventing falls, which may lead to improved health, enhanced mobility, more independence and high quality of life. Increased frequency of collisions are shown by older adults in swing phase and stance leg. Moreover, step length is also reduced and the frequency of multiple-step responses is increased. Older individuals rely more upon arm reactions to recover balance but the speed tends to decrease while initiation and execution of grasping reaction. And all reactions mentioned above are associated with increased risk of falling. The perturbation-based training program promote effective change in support program reactions that may help to reduce risk of falls and this training program should be part of fall prevention program and thus helping in improved quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proprioceptive neuromuscular facilitation | Experimental | Other: proprioceptive neuromuscular facilitationEach session including three PNF techniques: Balance training exercises,participants will be treated for 20 minutes with PNF techniques that included;Rhythmic initiation, slow reversal techniques practiced with D1 and D2 pattern in lower limb,repeated contraction and Resisted PNF.The Technique will be performed for 3 days per week in same order on all subjects. |
| pertubation based balance training | Experimental | Other: pertubation based balance trainingEach session will include a 5-10min warm-up,voluntary tasks intended to induce internal perturbations,voluntary tasks combined with external perturbations and a 5-10mins cool down.The technique will be performed for 2 sets of 10 repetitions on all subjects. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years - 85 years of age
- Gender: Both Male and Female
- Participants experienced fall >1 time in last 1 year.
- Patients should stand independently without upper limb support for >30s.
- Participants should tolerate at least 10 postural perturbations.
Key exclusion criteria (4 listed)
- Participants with body weight > 100kgs.
- Participants with lower extremity amputation.
- Severe osteoporosis
- Having recent illness, surgery, cognitive impairment or another neurological deficit.
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 |
|---|---|---|
| proprioceptive neuromuscular facilitationEach session including three proprioceptive neuromuscular facilitation techniques: Balance training exercises,participants will be treated for 20 minutes with PNF techniques that included;Rhythmic initiation, slow reversal techniques practiced with D1 and D2 pattern in lower limb,repeated contraction and Resisted PNF.The Technique will be performed for 3 days per week in same order on all subjects. | Other | proprioceptive neuromuscular facilitation |
| pertubation based balance trainingEach session will include a 5-10min warm-up,voluntary tasks intended to induce internal perturbations,voluntary tasks combined with external perturbations and a 5-10mins cool down.The technique will be performed for 2 sets of 10 repetitions on all subjects | Other | pertubation based balance training |
Primary outcome
berg balance scale
Time frame: week 6
Berg Balance Scale is the gold standard scale for assessment of Static and Dynamic Balance of a person. It is widely used in clinical settings. It consists of 14 balance related tasks. If a person performs the task independently it means a score of 4 and if a person is unable to do a task then a score of 0 is given. The sum of all the scores at the end will give us a final measure. It is a valid and reliable tool.
3 secondary outcomes
Time up and Go Test
Time frame: week 6
Quality of life Scale
Time frame: week 6
Modified John Hopkins Fall Risk Assessment Tool
Time frame: week 6
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 21 May 2024.
- Background: PubMed 25200877Halvarsson A, Dohrn IM, Stahle A. Taking balance training for older adults one step further: the rationale for and a description of a proven balance training programme. Clin Rehabil. 2015 May;29(5):417-25. doi: 10.1177/0269215514546770. Epub 2014 Sep 8.
- Background: PubMed 17540020Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.
- Background: PubMed 29710140Guirguis-Blake JM, Michael YL, Perdue LA, Coppola EL, Beil TL. Interventions to Prevent Falls in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Apr 24;319(16):1705-1716. doi: 10.1001/jama.2017.21962.
- Background: PubMed 20128337Beling J, Roller M. Multifactorial intervention with balance training as a core component among fall-prone older adults. J Geriatr Phys Ther. 2009;32(3):125-33. doi: 10.1519/00139143-200932030-00008.
- Background: PubMed 31803048Dunsky A. The Effect of Balance and Coordination Exercises on Quality of Life in Older Adults: A Mini-Review. Front Aging Neurosci. 2019 Nov 15;11:318. doi: 10.3389/fnagi.2019.00318. eCollection 2019.
- Background: PubMed 20175947Heydarnejad S, Dehkordi AH. The effect of an exercise program on the health-quality of life in older adults. A randomized controlled trial. Dan Med Bull. 2010 Jan;57(1):A4113.
- Background: PubMed 29390433You H, Zhang H, Liu J, Han T, Zhang M, Zhao W, Jiang S. Effect of balance training with Pro-kin System on balance in patients with white matter lesions. Medicine (Baltimore). 2017 Dec;96(51):e9057. doi: 10.1097/MD.0000000000009057.
- Background: PubMed 23023812Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.
- Background: PubMed 23816376Hnizdo S, Archuleta RA, Taylor B, Kim SC. Validity and reliability of the modified John Hopkins Fall Risk Assessment Tool for elderly patients in home health care. Geriatr Nurs. 2013 Sep-Oct;34(5):423-7. doi: 10.1016/j.gerinurse.2013.05.011. Epub 2013 Jun 29.
- Background: PubMed 26180312Seo KC, Kim HA. The effects of ramp gait exercise with PNF on stroke patients' dynamic balance. J Phys Ther Sci. 2015 Jun;27(6):1747-9. doi: 10.1589/jpts.27.1747. Epub 2015 Jun 30.
- 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.
Sania Aziz, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive neuromuscular facilitation and pertubation based balance training in people with Balance; Distorted, run by Riphah International University 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 5 inclusion and 4 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 21 May 2024. 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 (time frame: week 6). 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 NCT05086211, which also lists 10 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 21 May 2024.