- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856045
PNF vs Pertubation Based Balance Training in Subacute Stroke Patients.
Effects of Proprioceptive Neuromuscular Facilitation Exercises Versus Perturbation-based Balance Training on Balance, Coordination and Proprioception in Subacute Stroke Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54770
- Recruiting
- Services Hospital
-
Contact:
- Hira Jabeen
- Phone Number: 03234116506
- Email: hira.jabeen@riphah.edu.pk
-
Principal Investigator:
- nimra azmat, MSNMPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age:40-70 years.
- Gender: Male and female
- The Subacute stroke patients, at least 3 months post stroke.
- Patients able to stand without support from upper limb.
- Patients able to perform 10 meter walk test.
Exclusion Criteria:
- Neurological conditions other than stroke like Guillain barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Parkinson's disease, Transverse Myelitis etc.
- Patients with not intact higher mental function and cognition.
- Patients with grade 3 arthritis and traumatic injuries like spinal cord injuries and TBIs
- Other chronic disabling pathologies, orthopedic injuries that could impair locomotion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNF intervention group
Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output.
|
PNF involves both stretching and contracting (activation) of the muscle group being targeted in order to achieve maximum static flexibility, along with its D1&D2 flexion/extension patterns to improve dynamic flexibility and thus improving balance and coordination. total 8 weeks session was given to patients. 45 mins session/each day for 6 days a week. |
|
Experimental: PBBT(pertubation based balance training) intervention group
Perturbation-based balance training (also referred to as reactive balance training or perturbation training) utilizes a task-specific approach to balance training, applying repeated exposure to unpredictable mechanical perturbations that mimic balance disturbances experienced in daily life.
|
Perturbation-based balance training (PBT) is an emerging task-specific intervention that aims to improve reactive balance control after destabilizing perturbations in a safe and controlled environment. Pertubations are given by therapist in unexpected directions to challenge patients reactive balance. In this study pertubations will be given manually and on treadmill by a harness system. daily 45 mins of exercise session of pertuations divided into double leg foam roller, wobble board exercises and pertubations on treadmill were performed for total 8 weeks and 6 days a week. |
|
Experimental: PNF and PBBT intervention group
both techniques will be used
|
proprioceptive neuromuscular exercises, pertubation based balance training along with conventional physiotherapy exercises were given for 8 weeks and 6 days per week for around 45 mins.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tinetti Performance Oriented Mobility Assessment(POMA)
Time Frame: 8th week
|
The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's gait and balance abilities. Equipment needed are Hard armless chair, Stopwatch or wristwatch and 15 ft walkway.it takes 10-15 minutes to administer. total score is 28 interpretation: 25-28 = low fall risk 19-24 = medium fall risk < 19 = high fall risk |
8th week
|
|
FMA lower extremity
Time Frame: 8th week
|
The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is a widely used and recommended scale for evaluation of post-stroke motor impairment. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total |
8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hira Jabeen, Riphah International University
Publications and helpful links
General Publications
- Seo K, Park SH, Park K. The effects of stair gait training using proprioceptive neuromuscular facilitation on stroke patients' dynamic balance ability. J Phys Ther Sci. 2015 May;27(5):1459-62. doi: 10.1589/jpts.27.1459. Epub 2015 May 26.
- Mansfield A, Aqui A, Centen A, Danells CJ, DePaul VG, Knorr S, Schinkel-Ivy A, Brooks D, Inness EL, McIlroy WE, Mochizuki G. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. BMC Neurol. 2015 Jun 6;15:87. doi: 10.1186/s12883-015-0347-8.
- GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.
- Ribeiro T, Britto H, Oliveira D, Silva E, Galvao E, Lindquist A. Effects of treadmill training with partial body weight support and the proprioceptive neuromuscular facilitation method on hemiparetic gait: a randomized controlled study. Eur J Phys Rehabil Med. 2013 Aug;49(4):451-61. Epub 2012 Nov 20.
- Belas Dos Santos M, Barros de Oliveira C, Dos Santos A, Garabello Pires C, Dylewski V, Arida RM. A Comparative Study of Conventional Physiotherapy versus Robot-Assisted Gait Training Associated to Physiotherapy in Individuals with Ataxia after Stroke. Behav Neurol. 2018 Feb 20;2018:2892065. doi: 10.1155/2018/2892065. eCollection 2018.
- van Duijnhoven HJR, Roelofs JMB, den Boer JJ, Lem FC, Hofman R, van Bon GEA, Geurts ACH, Weerdesteyn V. Perturbation-Based Balance Training to Improve Step Quality in the Chronic Phase After Stroke: A Proof-of-Concept Study. Front Neurol. 2018 Nov 22;9:980. doi: 10.3389/fneur.2018.00980. eCollection 2018.
- Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
- Cayco CS, Gorgon EJR, Lazaro RT. Effects of proprioceptive neuromuscular facilitation on balance, strength, and mobility of an older adult with chronic stroke: A case report. J Bodyw Mov Ther. 2017 Oct;21(4):767-774. doi: 10.1016/j.jbmt.2016.10.008. Epub 2016 Oct 27.
- Cohen AL, Ferguson MA, Fox MD. Lesion network mapping predicts post-stroke behavioural deficits and improves localization. Brain. 2021 May 7;144(4):e35. doi: 10.1093/brain/awab002. No abstract available.
- Nguyen PT, Chou LW, Hsieh YL. Proprioceptive Neuromuscular Facilitation-Based Physical Therapy on the Improvement of Balance and Gait in Patients with Chronic Stroke: A Systematic Review and Meta-Analysis. Life (Basel). 2022 Jun 13;12(6):882. doi: 10.3390/life12060882.
- Park J, Kim TH. The effects of balance and gait function on quality of life of stroke patients. NeuroRehabilitation. 2019;44(1):37-41. doi: 10.3233/NRE-182467.
- Tyson SF, Sadeghi-Demneh E, Nester CJ. The effects of transcutaneous electrical nerve stimulation on strength, proprioception, balance and mobility in people with stroke: a randomized controlled cross-over trial. Clin Rehabil. 2013 Sep;27(9):785-91. doi: 10.1177/0269215513478227. Epub 2013 Mar 15.
- Gunning E, Uszynski MK. Effectiveness of the Proprioceptive Neuromuscular Facilitation Method on Gait Parameters in Patients With Stroke: A Systematic Review. Arch Phys Med Rehabil. 2019 May;100(5):980-986. doi: 10.1016/j.apmr.2018.11.020. Epub 2018 Dec 22.
- Handelzalts S, Kenner-Furman M, Gray G, Soroker N, Shani G, Melzer I. Effects of Perturbation-Based Balance Training in Subacute Persons With Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Mar;33(3):213-224. doi: 10.1177/1545968319829453. Epub 2019 Feb 15.
- Mansfield A, Schinkel-Ivy A, Danells CJ, Aqui A, Aryan R, Biasin L, DePaul VG, Inness EL. Does Perturbation Training Prevent Falls after Discharge from Stroke Rehabilitation? A Prospective Cohort Study with Historical Control. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2174-2180. doi: 10.1016/j.jstrokecerebrovasdis.2017.04.041. Epub 2017 Jun 1.
- Wu P, Zeng F, Li YX, Yu BL, Qiu LH, Qin W, Li J, Zhou YM, Liang FR. Changes of resting cerebral activities in subacute ischemic stroke patients. Neural Regen Res. 2015 May;10(5):760-5. doi: 10.4103/1673-5374.156977.
- Muehlbauer T. Effects of balance training on static and dynamic balance performance in healthy children: role of training duration and volume. BMC Res Notes. 2021 Dec 23;14(1):465. doi: 10.1186/s13104-021-05873-5.
- Morone G, Tramontano M, Iosa M, Shofany J, Iemma A, Musicco M, Paolucci S, Caltagirone C. The efficacy of balance training with video game-based therapy in subacute stroke patients: a randomized controlled trial. Biomed Res Int. 2014;2014:580861. doi: 10.1155/2014/580861. Epub 2014 May 5.
- Bergmann J, Krewer C, Muller F, Jahn K. A new cutoff score for the Burke Lateropulsion Scale improves validity in the classification of pusher behavior in subactue stroke patients. Gait Posture. 2019 Feb;68:514-517. doi: 10.1016/j.gaitpost.2018.12.034. Epub 2018 Dec 26.
- Villepinte C, Catella E, Martin M, Hidalgo S, Techene S, Lebely C, Castel-Lacanal E, de Boissezon X, Chih H, Gasq D. Validation of French upper limb Erasmus modified Nottingham Sensory Assessment in stroke. Ann Phys Rehabil Med. 2019 Jan;62(1):35-42. doi: 10.1016/j.rehab.2018.03.004. Epub 2018 Apr 13.
- Hernandez ED, Forero SM, Galeano CP, Barbosa NE, Sunnerhagen KS, Alt Murphy M. Intra- and inter-rater reliability of Fugl-Meyer Assessment of Lower Extremity early after stroke. Braz J Phys Ther. 2021 Nov-Dec;25(6):709-718. doi: 10.1016/j.bjpt.2020.12.002. Epub 2020 Dec 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/5341nimraazmat
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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