StrokeNCT06130839
Perturbation Based Training And Bobath-Based Trunk Exercises On Gait , Postural Control And Mobility
A study testing Rocker board training and Stable surface training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Rocker board training and Stable surface training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2023to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Rocker board training, Stable surface training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocker board trainingOther
Also called Experimental group
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.
Stable surface trainingOther
Also called Experimental group
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).
| Study group | Role | What they receive |
|---|---|---|
| perturbation based training | Experimental | 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. Receives: Other: Rocker board training |
| bobath based training | Experimental | 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. Receives: Other: Stable surface training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale
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"
Measured: 6 weeks
Timed Up and Go Test
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"
Measured: 6 weeks
Postural Assessment Scale for Stroke Patient
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"
Measured: 6 weeks
Functional Gait Assessment
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"
Measured: 6 weeks
Secondary outcomes (1)
Stroke Self-Efficacy Questionnaire
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"
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start10 Nov 2023
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130839
- Sponsor's protocol ID
- REC/0245Saba Sheikh
- Status last verified
- Apr 2025
- First submitted
- 9 Nov 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perturbation Based Training and Bobath-Based Trunk Exercises on Gait, Postural Control and Mobility in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT06130839
- Acronym / sponsor ID
- REC/0245Saba Sheikh
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| perturbation based training | Experimental | Other: Rocker board training1. 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. |
| bobath based training | Experimental | Other: Stable surface training1. 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocker board trainingAlso: Experimental groupThen 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 | perturbation based training |
| Stable surface trainingAlso: Experimental groupthe 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 | bobath based training |
Primary outcome
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"
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"
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"
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"
1 secondary outcome
Stroke Self-Efficacy Questionnaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aruba Saeed, PhD principal investigator
Riphah International University Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocker board training and Stable surface training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.