PBBT and WBV Effect on Balance and Gait in Stroke.
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Perturbation Exercises
Whole Body Vibration
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Perturbation Exercises, Whole body vibration, Stroke, Balance, Gait
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.
Sites / Locations
- Civil Hospital Daska, SialkotRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Perturbation Exercises
Whole Body Vibration
Arm Description
Perturbation Based Balance Training
Whole Body Vibration Therapy
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05588661
First Posted
October 17, 2022
Last Updated
October 17, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05588661
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Perturbation Exercises, Whole body vibration, Stroke, Balance, Gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Perturbation Exercises
Arm Type
Experimental
Arm Description
Perturbation Based Balance Training
Arm Title
Whole Body Vibration
Arm Type
Experimental
Arm Description
Whole Body Vibration Therapy
Intervention Type
Other
Intervention Name(s)
Perturbation Exercises
Intervention Description
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
Intervention Name(s)
Whole Body Vibration
Intervention Description
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 Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
6th week
Title
Dynamic Gait Index
Description
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.
Time Frame
6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binash Afzal, Phd*
Phone
03350318699
Email
binash.afzal@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Civil Hospital Daska, Sialkot
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51010
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rida Aziz, MS NMPT
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29487869
Citation
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.
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Citation
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Citation
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Citation
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PBBT and WBV Effect on Balance and Gait in Stroke.
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