PBBT and WBV Effect on Balance and Gait in Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Perturbation Exercises; Other: Whole Body Vibration

• Registration Number: NCT05588661
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2022-04-04
• Status Verified: 2022-10
• Primary Completion: 2022-10-15
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-20
• Study Completion: 2022-11-15
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perturbation Exercises	Perturbation Exercises	Perturbation Based Balance Training
Whole Body Vibration	Whole Body Vibration	Whole Body Vibration Therapy

Primary Outcome Measures

Name	Time	Method
Dynamic Gait Index	6th week	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.
Berg Balance Scale	6th week	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.

Trial Locations

Locations (1)

Civil Hospital Daska, Sialkot; 🇵🇰 Sialkot, Punjab, Pakistan