Minimal Clinically Important Difference of Clinical Test of Sensory Interaction on Balance in Individuals

Active, not recruiting

• Conditions: Stroke

• Registration Number: NCT06905730
• Lead Sponsor: Superior University

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	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):	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)	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

Trial Locations

Locations (1)

Superior University; 🇵🇰 Lahore, Punjab, Pakistan