- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06130839
Perturbation Based Training And Bobath-Based Trunk Exercises On Gait , Postural Control And Mobility
April 7, 2025 updated by: Riphah International University
Effects of Perturbation Based Training and Bobath-Based Trunk Exercises on Gait, Postural Control and Mobility in Post Stroke Patients
This study compares two approaches for rehabilitating stroke patients: Perturbation-Based Training and Bobath-Based Trunk Exercises.
The perturbation based training focuses on challenging patients with unexpected movements to improve their balance and stability.
While the Bobath method, concentrating on facilitating normal movement patterns.
The study aims to determine which approach yields better outcomes in terms of trunk control, balance, and functional recovery for stroke patients.
This study will also enable the individual to be more independent and minimize their falls.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cerebrovascular is a leading cause of physical impairment and long-term disability in the globe.
The complication of stroke is mobility impairment like balance, gait, and posture disorders.
This impairment leads to a higher risk of falls, reduced ability in daily activities, and difficulty restoring the overall health and quality of life.
Cerebrovascular accident is the second cause of fatality.
Hence, one of the primary objectives in stroke rehabilitation is to restore postural stability and functional balance, which is a combination of dynamic, static and reactive balance.
For improving postural stability and balance one such technique is the utilization of a rocker board, where a platform positioned on an unstable surface is used to challenge balance.
Whilst rocker boards have been used effectively for, postural stability, injury prevention, rehabilitation and balance enhancement.
Improvements in rocker board performance may be attributable to one or more of the following: muscle strengthening, enhanced intersegmental coordination, increase in brain activity in the supplementary motor area and/or enhanced feed-forward and feed-backward postural control mechanisms.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54400
- LGH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Able to walk with or without ambulatory aids
- Able to follow commands.
- Patients in the subacute and chronic stages associated with stroke hemiparesis (time since
- stroke onset 6 months- 1 year)
- Scoring > 21 on MMSE
Exclusion Criteria:
- Patients who have severe limitations in passive range of motion at lower extremities
- Visual and sensory deficits
- Patient who has contracture
- Orthopedic or any other neurological disorder which impair balance.
- Patients undergoing any other balance training protocol.
- Patients with recurrent strokes
- Participants who are currently participating in another clinical trial or research study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: perturbation based training
Trunk control exercises on Rocker Board in standing position first in medio-lateral direction for 10 min and then in anterio-posterior direction for 10 min with breaks in between. |
Then intervention will be applied to the perturbation group as mention below at Rocker board (50 x 45 cm).the group will perform 36 sessions (4 times per week over 8 weeks) and effects of interventions will be measured before treatment, at 4th and after8th week (pre, mid and post intervention).
Trunk control exercises on Rocker Board in standing position first in medio-lateral direction for 10 min and then in anterio-posterior direction for 10 min with breaks in between.
Other Names:
|
|
Experimental: bobath based training
Functional reach of shoulder, anterior, right, and left sides. |
the group will perform 36 sessions (4 times per week over 8 weeks) and effects of interventions will be measured before treatment, at 4th and after 8th week (pre, mid and post intervention).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Impairment Scale
Time Frame: 6 weeks
|
It is used to measure motor impairment of the trunk after stroke.
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance "Change will be measured from Baseline to 6 weeks"
|
6 weeks
|
|
Timed Up and Go Test
Time Frame: 6 weeks
|
It is for the assessment of lower extremity function, mobility and fall risk.
scoring criteria < 10 seconds = normal.
< 20 seconds = good mobility; can walk outside alone; does not require a walking aid.
< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.
"Change will be measured from Baseline to 6 weeks"
|
6 weeks
|
|
Postural Assessment Scale for Stroke Patient
Time Frame: 6 weeks
|
It is used for the assessments of postural control in stroke patients.
It measures the ability of an individual with stroke to maintain stable postures and equilibrium during positional changes.
It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36.
"Change will be measured from Baseline to 6 weeks"
|
6 weeks
|
|
Functional Gait Assessment
Time Frame: 6 weeks
|
It is for assessment of postural stability during walk.
3 Normal is able to ambulate for 10 steps heel to toe with no staggering.
2 Mild impairment, ambulates 7-9 steps. 1 Moderate impairment, ambulates 4-7 steps.
0 Severe impairment, ambulates less than 4 steps heel to toe or cannot perform without assistance.
"Change will be measured from Baseline to 6 weeks"
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke Self-Efficacy Questionnaire
Time Frame: 6 weeks
|
It evaluate self-efficacy as a result of being able to successfully perform a specific action in stroke patients.
It is a self-reported questionnaire about level of confidence reported on a 0 to 10 scale (0 = not confident, 10 = very confident) when completing 13 activities of daily life following stroke.
"Change will be measured from Baseline to 6 weeks"
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aruba Saeed, PhD, Riphah International University Pakistan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2023
Primary Completion (Actual)
April 10, 2024
Study Completion (Actual)
April 10, 2024
Study Registration Dates
First Submitted
November 9, 2023
First Submitted That Met QC Criteria
November 13, 2023
First Posted (Actual)
November 14, 2023
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/0245Saba Sheikh
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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