Clinical trial NCT05588661: PBBT and WBV Effect on Balance and Gait in Stroke
Official title: Comparative Effects of Perturbation Based Balance Training and Whole Body Vibration on Balance and Gait in Sub-acute Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Perturbation Exercises
Whole body vibration
Stroke
Balance
Gait
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 6th week
measure: Dynamic Gait Index
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Civil Hospital Daska, Sialkot
state: Punjab
Study officials:
affiliation: Riphah International University
name: Binash Afzal, Phd*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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citation: 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.
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