Balance; DistortedNCT06459544
Effects of Bobath Approach With Core Stability to Improve Balance in Stroke
A study testing Bobath Technique with core stability and Conventional treatment for balance in people with Balance; Distorted, run by Superior University at 1 site in Pakistan.
Trial summary
Bobath technique with core stability exercises to improve balance in stroke. Randomized clinical trial study design will be followed. Data will be collected from following centers: Naseer Hospital, North Ravi Hospital, Bajwa Hoaspital,Minhaj Physiotherapy Centre, Home visits. Probability Random Sampling is used. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- Bobath Technique with core stability and Conventional treatment for balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Oct 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 30 - 65
- Both Gender
- more than 1 month or less than 6 months since onset of stroke
- GCS SCORE 11 TO 15
Who cannot join
- consist of GCS less than 10
- any pathological fracture
- diagnosed orthostatic hypotension
- Comorbidities like IHD and Rheumatologic disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Naseer Hospital 16 A , AHMAD BLOCK NEW GARDEN TOWN
Lahore, Punjab Province
About this study
Bobath technique with core stability exercises to improve balance in stroke. Randomized clinical trial study design will be followed. Data will be collected from following centers: Naseer Hospital, North Ravi Hospital, Bajwa Hoaspital,Minhaj Physiotherapy Centre, Home visits. Probability Random Sampling is used.
- Conditions
- Balance; Distorted
- Being tested
- Bobath Technique with core stability, Conventional treatment for balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath Technique with core stabilityDiagnostic test
exercise to improve balance motor learning stretegy is basically used. Bobath in which we assess patient's posture, inhibit the abnormal muscle tone and facilitate normal patterns and posture through handling and posture. we also use sensory inputs like propioception to promote normal pattern. we take some exercise based on bobath technique with core stability like Bridging with core stability, quadroped with core stability, sitting and standing with core stablity, single leg standing , dynamic balance with core stability.treatment plan based on 45 minutes per day, 6 days a week for 4 week.
Conventional treatment for balanceOther
like stretching, strenthening the Lower extremity muscles , PROMS, AAROMS,AROMS, RROMS,some balance exercise like sitting and standing
| Study group | Role | What they receive |
|---|---|---|
| Bobath Technique with core stability | Experimental | Not described Receives: Diagnostic Test: Bobath Technique with core stability |
| Conventional treatment for balance | Other | Not described Receives: Other: Conventional treatment for balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance berg scale
Evaluates balance during a sequence of pre-planned tasks in an objective manner. It takes 20 minutes and consists of 14 tests. It is 5 points ordinal scale with 0 = lowest degree of function and 4 = highest level. The highest score is 14
Measured: 12 Months
Trunk Impairment Scale
Evaluate static and dynamic balance and trunk coordination.score goes from 0 = lowest performance and 23 = highest performance. Scores vary from 0 to 16.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459544
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/726
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bobath Approach With Core Stability to Improve Balance in Stroke
- ClinicalTrials.gov ID
- NCT06459544
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/726
- Conditions
- Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
Bobath technique with core stability exercises to improve balance in stroke. Randomized clinical trial study design will be followed. Data will be collected from following centers: Naseer Hospital, North Ravi Hospital, Bajwa Hoaspital,Minhaj Physiotherapy Centre, Home visits. Probability Random Sampling is used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bobath Technique with core stability | Experimental | Diagnostic Test: Bobath Technique with core stability |
| Conventional treatment for balance | Other | Other: Conventional treatment for balance |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 30 - 65
- Both Gender
- more than 1 month or less than 6 months since onset of stroke
- GCS SCORE 11 TO 15
Key exclusion criteria (4 listed)
- consist of GCS less than 10
- any pathological fracture
- diagnosed orthostatic hypotension
- Comorbidities like IHD and Rheumatologic disease.
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 |
|---|---|---|
| Bobath Technique with core stabilityexercise to improve balance motor learning stretegy is basically used. Bobath in which we assess patient's posture, inhibit the abnormal muscle tone and facilitate normal patterns and posture through handling and posture. we also use sensory inputs like propioception to promote normal pattern. we take some exercise based on bobath technique with core stability like Bridging with core stability, quadroped with core stability, sitting and standing with core stablity, single leg standing , dynamic balance with core stability.treatment plan based on 45 minutes per day, 6 days a week for 4 week. | Diagnostic test | Bobath Technique with core stability |
| Conventional treatment for balancelike stretching, strenthening the Lower extremity muscles , PROMS, AAROMS,AROMS, RROMS,some balance exercise like sitting and standing | Other | Conventional treatment for balance |
Primary outcome
Balance berg scale
Time frame: 12 Months
Evaluates balance during a sequence of pre-planned tasks in an objective manner. It takes 20 minutes and consists of 14 tests. It is 5 points ordinal scale with 0 = lowest degree of function and 4 = highest level. The highest score is 14
Trunk Impairment Scale
Time frame: 12 months
Evaluate static and dynamic balance and trunk coordination.score goes from 0 = lowest performance and 23 = highest performance. Scores vary from 0 to 16.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bobath Technique with core stability and Conventional treatment for balance in people with Balance; Distorted, run by Superior 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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?
Results are not available in the source record.
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?
Balance berg scale (time frame: 12 Months). The study lists 2 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 14 Jun 2024.