PBBT and WBV Effect on Balance and Gait in Stroke

NCT05588661 | Completed

• 1 other identifier: REC/RCR&AHS/22/0229
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Perturbation Exercises; Whole body vibration; Stroke; Balance; Gait

Outcome Measures

Primary Outcomes (2)

• Berg Balance Scale

  Changes from baseline, BBS was designed to measure the static and dynamic balance in post stroke patients.It consist of 14 items which scores vary from 0-4. Maximum no. of score ranges from 0-56. A person with a score 0-20 range will likely need the assistance of a wheelchair to move around safely. A person with a score 21 to 40 range will need some type of walking assistance, such as a cane or a walker. 41 to 56: A person with a score in this range is considered independent and should be able to move around safely without assistance.

  6th week

• Dynamic Gait Index

  Changes from baseline,The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk.It includes eight items,each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24 as this is the total no. of score. If score is \< 19/24 it indicates predictive of falls in the elderly, and score \> 22/24 indicates the safe ambulators.

  6th week

Study Arms (2)

Perturbation Exercises

EXPERIMENTAL

Perturbation Based Balance Training

Other: Perturbation Exercises

Whole Body Vibration

EXPERIMENTAL

Whole Body Vibration Therapy

Other: Whole Body Vibration

Interventions

Perturbation Exercises 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.

Perturbation Exercises

Whole Body Vibration 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

Whole Body Vibration

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Civil Hospital Daska, Sialkot

Sialkot, Punjab Province, 51010, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 29487869 BACKGROUND

• 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.

  PMID: 31222544 BACKGROUND

• 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.

  PMID: 31742486 BACKGROUND

• 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.

  PMID: 29622098 BACKGROUND

• 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.

  PMID: 29675114 BACKGROUND

• 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.

  PMID: 30326747 BACKGROUND

• 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.

  PMID: 30696491 BACKGROUND

• 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.

  PMID: 30524360 BACKGROUND

• 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.

  PMID: 34285892 BACKGROUND

• 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.

  PMID: 33354124 BACKGROUND

• 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.

  PMID: 33508725 BACKGROUND

• 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.

  PMID: 30476999 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Binash Afzal, Phd*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: April 4, 2022
• Primary Completion: October 15, 2022
• Study Completion: November 15, 2022
• Last Updated: January 30, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)