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NCT Number: NCT06905730

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

"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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Superior University

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Minimal Clinically Important Difference (MCID) of Clinical Test of Sensory Interaction on Balance (CTSIB) in Individuals With Sub-Acute Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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