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

NCT06905730 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/790
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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

  12 Months

Study Arms (1)

sensory integration deficits in balance

Diagnostic Test: sensory integration deficits in balance

Interventions

sensory integration deficits in balance DIAGNOSTIC_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

sensory integration deficits in balance

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: February 20, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)