search
Back to results

PNF vs Pertubation Based Balance Training in Subacute Stroke Patients.

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
PNF(proprioceptive neuromuscular facilitation exercises)
PBBT (pertubation based balance training)
PNF and PBBT intervention group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring hemiplegia, cardiovascular accident, pnf, PBBT (pertubation based balance training)

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Services HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PNF intervention group

PBBT(pertubation based balance training) intervention group

PNF and PBBT intervention group

Arm Description

Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output.

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.

both techniques will be used

Outcomes

Primary Outcome Measures

Tinetti Performance Oriented Mobility Assessment(POMA)
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
FMA lower extremity
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

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05856045
Brief Title
PNF vs Pertubation Based Balance Training in Subacute Stroke Patients.
Official Title
Effects of Proprioceptive Neuromuscular Facilitation Exercises Versus Perturbation-based Balance Training on Balance, Coordination and Proprioception in Subacute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2023 (Actual)
Primary Completion Date
October 18, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients, it will be a randomized clinical trial.
Detailed Description
Stroke is the major cause of disability and mortality worldwide. Stroke is defined as an abrupt neurological outburst caused by impaired perfusion through the blood vessels to the brain. Every year the number of strokes affected individuals are rising thereby putting an extra pressure on socioeconomic conditions in developing countries. Major complications of stroke include hemiplegia leading to upper limb dysfunction along with gait abnormalities. This study will be conducted to determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients. The randomized clinical trial will be conducted, participants will be selected through Non probability convenience sampling technique and then randomly allocated into three treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
hemiplegia, cardiovascular accident, pnf, PBBT (pertubation based balance training)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PNF intervention group
Arm Type
Experimental
Arm Description
Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output.
Arm Title
PBBT(pertubation based balance training) intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
PNF and PBBT intervention group
Arm Type
Experimental
Arm Description
both techniques will be used
Intervention Type
Other
Intervention Name(s)
PNF(proprioceptive neuromuscular facilitation exercises)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PBBT (pertubation based balance training)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PNF and PBBT intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinetti Performance Oriented Mobility Assessment(POMA)
Description
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
Time Frame
8th week
Title
FMA lower extremity
Description
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
Time Frame
8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hira jabeen
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54770
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hira jabeen
Phone
03234116506
Email
hira.jabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
nimra azmat, MSNMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33076218
Citation
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.
Results Reference
background
PubMed Identifier
30871944
Citation
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.
Results Reference
background
PubMed Identifier
33899085
Citation
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.
Results Reference
background
PubMed Identifier
35743913
Citation
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.
Results Reference
background
PubMed Identifier
30741699
Citation
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.
Results Reference
background
PubMed Identifier
23503739
Citation
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.
Results Reference
background
PubMed Identifier
29037625
Citation
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.
Results Reference
background
PubMed Identifier
26157240
Citation
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.
Results Reference
background
PubMed Identifier
30582917
Citation
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.
Results Reference
background
PubMed Identifier
30767613
Citation
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.
Results Reference
background
PubMed Identifier
26048054
Citation
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.
Results Reference
background
PubMed Identifier
28579506
Citation
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.
Results Reference
background
PubMed Identifier
23172402
Citation
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.
Results Reference
background
PubMed Identifier
30524360
Citation
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.
Results Reference
background
PubMed Identifier
29675114
Citation
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.
Results Reference
background
PubMed Identifier
26109950
Citation
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.
Results Reference
background
PubMed Identifier
34949215
Citation
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.
Results Reference
background
PubMed Identifier
24877116
Citation
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.
Results Reference
background
PubMed Identifier
30623845
Citation
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.
Results Reference
background
PubMed Identifier
29660413
Citation
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.
Results Reference
background
PubMed Identifier
33358073
Citation
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.
Results Reference
background

Learn more about this trial

PNF vs Pertubation Based Balance Training in Subacute Stroke Patients.

We'll reach out to this number within 24 hrs