StrokeNCT06905730
Minimal Clinically Important Difference of Clinical Test of Sensory Interaction on Balance in Individuals
An observational study of Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
"Stroke is a major cause of disability worldwide, often leading to balance impairments due to deficits in sensory integration and motor control. These impairments hinder postural stability and functional independence, making balance rehabilitation a critical focus in sub-acute stroke care. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- sensory integration deficits in balance
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Difference of Clinical Test of Sensory Interaction on Balance in Individuals Withhaving a Montreal Cognitive Assessment (MoCA) score of at least 24, indicating normal cognitive function or only mild cognitive impairment. Participants must have a Functional Ambulation Classification (FAC) score of 3, indicating independent ambulation with supervision or the use of a walking aid.
Who may be able to join
- Type of stroke Participants must have experienced a first unilateral hemispheric supratentorial stroke, which may be either ischemic or hemorrhagic in nature.
- Only individuals who have been clinically diagnosed with a stroke within the past 3 to 6 months will be included.
- Participants must have a Functional Ambulation Classification (FAC) score of 3, indicating independent ambulation with supervision or the use of a walking aid.
- The individual must have sufficient cognitive and communication abilities to understand and follow instructions during assessments.
- The study will include patients in the early subacute phase of stroke recovery, defined as 7 days to 3 months post-onset.
- Participants must have a Montreal Cognitive Assessment (MoCA) score of at least 24, indicating normal cognitive function or only mild cognitive impairment
Who cannot join
- Individuals with severe cognitive impairments that prevent them from understanding, consenting to, or following simple instructions will be excluded.
- Participants with uncontrolled medical conditions such as cardiovascular disease or uncontrolled diabetes will not be eligible for the study.
- Individuals diagnosed with nerve compression conditions affecting motor or sensory function will be excluded.
- Patients exhibiting significant hemispatial neglect following a stroke will not be included in the study.
- Participants showing signs of unilateral spatial neglect, impacting their ability to process stimuli on one side, will be excluded.
- Patients who test positive for unilateral spatial neglect using the Catherine Line Bisection Test will be excluded.
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- Individuals with severe visual impairments that compromise independent ambulation will not be eligible.
- Patients with gait disturbances due to conditions other than stroke (e.g., Parkinson's disease, severe arthritis) will be excluded.
- Individuals who are unable to comply with study protocols or behavioral requirements will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal Clinically Important Difference (MCID) of Clinical Test of Sensory Interaction on Balance (CTSIB) in Individuals With Sub-Acute Stroke
"Stroke is a major cause of disability worldwide, often leading to balance impairments due to deficits in sensory integration and motor control. These impairments hinder postural stability and functional independence, making balance rehabilitation a critical focus in sub-acute stroke care.
Read the detailed description
The objective of this study is to determine the Minimal Clinically Important Difference (MCID) for the Clinical Test of Sensory Interaction on Balance (CTSIB) in individuals with sub-acute stroke rehabilitation. CTSIB evaluates the sensory contributions (visual, vestibular, and somatosensory) to balance by testing an individual's ability to maintain stability under various conditions. Additionally, the Berg Balance Scale (BBS) will be used to assess functional balance, and the Global Rating of Change (GRC) will be included as a subjective measure to gauge participants' perceived improvement in balance and functional performance.
- Conditions
- Stroke
- Being tested
- sensory integration deficits in balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory integration deficits in balanceDiagnostic test
By assessing sensory integration deficits in balance recovery, the study will help establish meaningful thresholds for rehabilitation outcomes, guiding clinicians in tailoring therapy for improved post-stroke balance and functional independence
| Study group | Role | What they receive |
|---|---|---|
| sensory integration deficits in balance | Not described Receives: Diagnostic Test: sensory integration deficits in balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
Berg balance scale scores range from 0 to 56. The lower your score, the more at risk you are for losing your balance. The higher your score, the better your functional mobility (ability to move effectively and safely)
Measured: 12 Months
Functional Ambulation Classification (FAC):
The Functional Ambulation Classification (FAC) is a tool used to assess and categorize functional mobility and gait in patients, ranging from non-functional ambulation (0) to independent ambulation (5), quantifying levels of assistance, supervision, and limited mobility.
Measured: 12 Months
Global Rating of Change (GRC)
The Global Rating of Change (GRC) scale is a tool used to assess a patient's perceived improvement or deterioration over time, typically following treatment, on a scale ranging from "a very great deal worse" (-7) to "a very great deal better" (+7), with 0 indicating "no change
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 posted1 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 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
- NCT06905730
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/790
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Clinically Important Difference (MCID) of Clinical Test of Sensory Interaction on Balance (CTSIB) in Individuals With Sub-Acute Stroke
- ClinicalTrials.gov ID
- NCT06905730
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/790
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 1 Apr 2025 (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.
"Stroke is a major cause of disability worldwide, often leading to balance impairments due to deficits in sensory integration and motor control. These impairments hinder postural stability and functional independence, making balance rehabilitation a critical focus in sub-acute stroke care.
Detailed description
The objective of this study is to determine the Minimal Clinically Important Difference (MCID) for the Clinical Test of Sensory Interaction on Balance (CTSIB) in individuals with sub-acute stroke rehabilitation. CTSIB evaluates the sensory contributions (visual, vestibular, and somatosensory) to balance by testing an individual's ability to maintain stability under various conditions. Additionally, the Berg Balance Scale (BBS) will be used to assess functional balance, and the Global Rating of Change (GRC) will be included as a subjective measure to gauge participants' perceived improvement in balance and functional performance.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sensory integration deficits in balance | – | Diagnostic Test: sensory integration deficits in balance |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Difference of Clinical Test of Sensory Interaction on Balance in Individuals Withhaving a Montreal Cognitive Assessment (MoCA) score of at least 24, indicating normal cognitive function or only mild cognitive impairment. Participants must have a Functional Ambulation Classification (FAC) score of 3, indicating independent ambulation with supervision or the use of a walking aid.
Key inclusion criteria (6 listed)
- Type of stroke Participants must have experienced a first unilateral hemispheric supratentorial stroke, which may be either ischemic or hemorrhagic in nature.
- Only individuals who have been clinically diagnosed with a stroke within the past 3 to 6 months will be included.
- Participants must have a Functional Ambulation Classification (FAC) score of 3, indicating independent ambulation with supervision or the use of a walking aid.
- The individual must have sufficient cognitive and communication abilities to understand and follow instructions during assessments.
- The study will include patients in the early subacute phase of stroke recovery, defined as 7 days to 3 months post-onset.
Key exclusion criteria (9 listed)
- Individuals with severe cognitive impairments that prevent them from understanding, consenting to, or following simple instructions will be excluded.
- Participants with uncontrolled medical conditions such as cardiovascular disease or uncontrolled diabetes will not be eligible for the study.
- Individuals diagnosed with nerve compression conditions affecting motor or sensory function will be excluded.
- Patients exhibiting significant hemispatial neglect following a stroke will not be included in the study.
- Participants showing signs of unilateral spatial neglect, impacting their ability to process stimuli on one side, will be excluded.
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 |
|---|---|---|
| sensory integration deficits in balanceBy assessing sensory integration deficits in balance recovery, the study will help establish meaningful thresholds for rehabilitation outcomes, guiding clinicians in tailoring therapy for improved post-stroke balance and functional independence | Diagnostic test | sensory integration deficits in balance |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 12 Months
Berg balance scale scores range from 0 to 56. The lower your score, the more at risk you are for losing your balance. The higher your score, the better your functional mobility (ability to move effectively and safely)
Functional Ambulation Classification (FAC):
Time frame: 12 Months
The Functional Ambulation Classification (FAC) is a tool used to assess and categorize functional mobility and gait in patients, ranging from non-functional ambulation (0) to independent ambulation (5), quantifying levels of assistance, supervision, and limited mobility.
Global Rating of Change (GRC)
Time frame: 12 Months
The Global Rating of Change (GRC) scale is a tool used to assess a patient's perceived improvement or deterioration over time, typically following treatment, on a scale ranging from "a very great deal worse" (-7) to "a very great deal better" (+7), with 0 indicating "no change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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?
An observational study of Stroke, 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 1 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?
This study is still under way. Results are not available in the source record yet.
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?
Berg Balance Scale (BBS) (time frame: 12 Months). The study lists 3 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 1 Apr 2025.