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Completed

NCT Number: NCT05588661

PBBT and WBV Effect on Balance and Gait in Stroke

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.

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Key information

Conditions

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

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Civil Hospital Daska, Sialkot

Sialkot, Punjab Province, 51010, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Berg Balance Scale

    Time frame: 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.

  2. Dynamic Gait Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Perturbation Based Balance Training and Whole Body Vibration on Balance and Gait in Sub-acute Stroke Patients.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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