Clinical trial NCT06905730: Minimal Clinically Important Difference of Clinical Test of Sensory Interaction on Balance in Individuals
Official title: Minimal Clinically Important Difference (MCID) of Clinical Test of Sensory Interaction on Balance (CTSIB) in Individuals With Sub-Acute Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 12 Months
measure: Functional Ambulation Classification (FAC):
timeFrame: 12 Months
measure: Global Rating of Change (GRC)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Superior University
state: Punjab
Study officials:
References: