PBBT and WBV Effect on Balance and Gait in Stroke

NCT ID: NCT05588661

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2022-11-15

Brief Summary

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The goal of this clinical trial is to compare the effects of perturbation based balance exercises with whole body vibration training in sub-acute stroke patients and to evaluate their effects on balance, and gait. The main aim to :

* To evaluate their effects on balance, and gait.
* Comparison of these rehabilitation protocols and identify the more efficacious treatment.

Participants will perform perturbation based balance training and whole body vibration therapy to improve balance and gait.

If there is a comparison group: Researchers will compare both groups to see both interventions effects.

Detailed Description

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Stroke usually causes impairments in a variety of areas, such as cognition, emotion, mobility limitation, sensory loss, and there after results in imbalance and gait disability as well as impairment of the activities of daily living (ADLs). Poor balance control have a negative influence on the recovery of gait and motor function. Many therapeutic interventions, such as visual feedback training, robotic devices, mirror therapy, and motor imagery training have been performed to improve balance control.

Reactive balance training (RBT) has emerged as a potential strategy for improving balance and participants withstood greater-magnitude perturbations before requiring multiple steps, relative to those who completed weight-shifting/gait training in sub-acute and chronic stroke patients.

Whole-body vibration (WBV) therapy used in clinical practice for improving neuro-motor performance in various patient populations and this training reduce disability by improving balance, gait performance, and mobility in stroke patients.

According to previous literature there was a lack of comparison of these two studies. In previous literature, both of these therapeutic options i.e., Perturbation based balance training (PBBT) and whole body vibration (WBV) training were used separately to see the effects in stroke population but not in combination. In this study the comparison will be done between these two exercise protocols. Consequences will be manipulated for balance, and gait by using validated tools.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Perturbation Exercises

Perturbation Based Balance Training

Group Type EXPERIMENTAL

Perturbation Exercises

Intervention Type OTHER

Perturbation exercises will be performed 3 times in a week for 6 weeks for 10-15 minutes per session with baseline treatment for total 30 minutes.

Total 18 sessions will be given to the patients.

Whole Body Vibration

Whole Body Vibration Therapy

Group Type EXPERIMENTAL

Whole Body Vibration

Intervention Type OTHER

It will be performed 3 times in a week for 10-15 minutes per session with baseline treatment for total 30 mints.

Total 18 sessions will be given for 6 weeks

Interventions

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Perturbation Exercises

Perturbation exercises will be performed 3 times in a week for 6 weeks for 10-15 minutes per session with baseline treatment for total 30 minutes.

Total 18 sessions will be given to the patients.

Intervention Type OTHER

Whole Body Vibration

It will be performed 3 times in a week for 10-15 minutes per session with baseline treatment for total 30 mints.

Total 18 sessions will be given for 6 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed patient of ischemic stroke (12 week to 20 weeks).
* Male and female, (40-60 year).
* Able to maintain standing posture, 4-5 score on level of independence scale.
* Patients able to perform 2-meter walk test.
* Score less than 20-24/56 on berg balance scale.

Exclusion Criteria

* Patients with other neurological disorders (Alzheimer's, Parkinson's vestibular impairments etc.)
* Any significant balance impairment on Berg Balance Scale.
* Orthopaedic Problems.
* Patients who can't perform 30 sec sit to stand.
* Patients with any trauma, and blindness.
* Lower extremity weight bearing pain.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Binash Afzal, Phd*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Civil Hospital Daska, Sialkot

Sialkot, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Park YJ, Park SW, Lee HS. Comparison of the Effectiveness of Whole Body Vibration in Stroke Patients: A Meta-Analysis. Biomed Res Int. 2018 Jan 2;2018:5083634. doi: 10.1155/2018/5083634. eCollection 2018.

Reference Type BACKGROUND
PMID: 29487869 (View on PubMed)

Sparaco M, Ciolli L, Zini A. Posterior circulation ischaemic stroke-a review part I: anatomy, aetiology and clinical presentations. Neurol Sci. 2019 Oct;40(10):1995-2006. doi: 10.1007/s10072-019-03977-2. Epub 2019 Jun 20.

Reference Type BACKGROUND
PMID: 31222544 (View on PubMed)

Schinkel-Ivy A, Huntley AH, Danells CJ, Inness EL, Mansfield A. Improvements in balance reaction impairments following reactive balance training in individuals with sub-acute stroke: A prospective cohort study with historical control. Top Stroke Rehabil. 2020 May;27(4):262-271. doi: 10.1080/10749357.2019.1690795. Epub 2019 Nov 19.

Reference Type BACKGROUND
PMID: 31742486 (View on PubMed)

Hasan TF, Rabinstein AA, Middlebrooks EH, Haranhalli N, Silliman SL, Meschia JF, Tawk RG. Diagnosis and Management of Acute Ischemic Stroke. Mayo Clin Proc. 2018 Apr;93(4):523-538. doi: 10.1016/j.mayocp.2018.02.013.

Reference Type BACKGROUND
PMID: 29622098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29675114 (View on PubMed)

Kim J, Kim DY, Chun MH, Kim SW, Jeon HR, Hwang CH, Choi JK, Bae S. Effects of robot-(Morning Walk(R)) assisted gait training for patients after stroke: a randomized controlled trial. Clin Rehabil. 2019 Mar;33(3):516-523. doi: 10.1177/0269215518806563. Epub 2018 Oct 16.

Reference Type BACKGROUND
PMID: 30326747 (View on PubMed)

de Rooij IJM, van de Port IGL, Visser-Meily JMA, Meijer JG. Virtual reality gait training versus non-virtual reality gait training for improving participation in subacute stroke survivors: study protocol of the ViRTAS randomized controlled trial. Trials. 2019 Jan 29;20(1):89. doi: 10.1186/s13063-018-3165-7.

Reference Type BACKGROUND
PMID: 30696491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30524360 (View on PubMed)

Kim JW, Lee JH. Effect of whole-body vibration therapy on lower extremity function in subacute stroke patients. J Exerc Rehabil. 2021 Jun 30;17(3):158-163. doi: 10.12965/jer.2142246.123. eCollection 2021 Jun.

Reference Type BACKGROUND
PMID: 34285892 (View on PubMed)

Sade I, Cekmece C, Inanir M, SelCuk B, Dursun N, Dursun E. The Effect of Whole Body Vibration Treatment on Balance and Gait in Patients with Stroke. Noro Psikiyatr Ars. 2019 Aug 20;57(4):308-311. doi: 10.29399/npa.23380. eCollection 2020 Dec.

Reference Type BACKGROUND
PMID: 33354124 (View on PubMed)

Gath CF, Gianella MG, Bonamico L, Olmos L, Russo MJ. Prediction of Balance After Inpatient Rehabilitation in Stroke Subjects with Severe Balance Alterations at the Admission. J Stroke Cerebrovasc Dis. 2021 Apr;30(4):105627. doi: 10.1016/j.jstrokecerebrovasdis.2021.105627. Epub 2021 Jan 25.

Reference Type BACKGROUND
PMID: 33508725 (View on PubMed)

Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.

Reference Type BACKGROUND
PMID: 30476999 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/22/0229

Identifier Type: -

Identifier Source: org_study_id

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