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

March 25, 2025 updated by: Muhammad Naveed Babur, Superior University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Superior University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
sensory integration deficits in balance
Diagnostic test: sensory integration deficits in balance
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
12 Months
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.
12 Months
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
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSRSW/Batch-Fall23/790

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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