- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05086211
PNFand Perturbations Based Exercises on Balance Training in Elder Population
Comparison of Effects of PNF Techniques and Perturbation Based Balance Training on Risk of Fall and Quality of Life in Elderly Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Rawalpindi, Punjab, Pakistan
- Muzzaffar Khan Surgical Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Participants with body weight > 100kgs.
- Participants with lower extremity amputation.
- Severe osteoporosis
- Having recent illness, surgery, cognitive impairment or another neurological deficit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: proprioceptive neuromuscular facilitation
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. |
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. |
|
Experimental: pertubation based balance training
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time up and Go Test
Time Frame: week 6
|
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.
|
week 6
|
|
Quality of life Scale
Time Frame: week 6
|
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)
|
week 6
|
|
Modified John Hopkins Fall Risk Assessment Tool
Time Frame: week 6
|
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%
|
week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: sania aziz, MSNMPT, Riphah International University
Publications and helpful links
General Publications
- Mansfield 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.
- Dunsky 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.
- 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.
- Guirguis-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.
- Beling 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.
- Heydarnejad 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.
- You 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.
- Godi 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.
- Hnizdo 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.
- Seo 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.
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
- Syeda Maria nazir
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.
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