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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: perturbation based training
  1. Stretching of the erector spinae,
  2. latissimus dorsi, gluteus Medius, gluteus minimums, and gluteus maximus (knee to chest) Pelvic Bridging Exercises
  3. Strengthening Exercises of latissimus dorsi muscle
  4. Pelvic Bridging Exercises include the gluteus maximus and quadriceps
  5. Rocker board:

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: Rocker board training
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 group
Experimental: bobath based training
  1. Stretching of the latissimus dorsi muscle
  2. Functional use and strengthening of the latissimus dorsi.
  3. Functional strengthening of abdominal and oblique abdominal muscles
  4. Placing exercises to facilitate trunk extension
  5. Rotations and counter-rotations (right and left) of the hips with the trunk extended Training of lumbar spine stabilizers

Functional reach of shoulder, anterior, right, and left sides.
Other: Stable surface training
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:
  • Experimental group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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