Sensory Integration Disorders in Patients With MS Including Disease Advancement and Relapses in the Last Year

July 4, 2022 updated by: Pomeranian Medical University Szczecin

Sensory Integration Disorders in Multiple Sclerosis

the aim of the study was to assess the occurrence of sensory integration disorders in people with SI depending on the stage of the disease and relapses in the last year;analysis of sensory integration disorders in patients with Ms and healthy people

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

141 patients diagnosed with RRSM were enrolled in the study. The control group consisted of 72 healthy people. The Sensory Integration Assessment Scale in Adults (SPD) was used to test sensory integration, and an original questionnaire was carried out containing information on age, gender, frequency of relapses in the last year, and duration of the disease.

Study Type

Observational

Enrollment (Actual)

2

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

  • Poland
    • Unii Lubelskiej
      • Szczecin, Unii Lubelskiej, Poland, 71-228
        • Departmen of Neurology

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

Ages Eligible for Study

30 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with relapsing-remitting MS were qualified for the study; aged 30 to 45

Description

Inclusion Criteria:

  • health of a person
  • aged 30-45 years
  • without diagnosed disorders of sensory integration and MS

Exclusion Criteria:

  • diagnosed disorders of sensory integration
  • diagnosed with Ms

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
Intervention / Treatment
people with MS
People with MS with relapsing-remitting form
Diagnostic test: Scale for the Assessment of Sensory Integration in Adults
In people with MS and people with health of similar age, a test was performed to assess sensory integration in adults
healthy people
people from the age of 30-45 years old
Diagnostic test: Scale for the Assessment of Sensory Integration in Adults
In people with MS and people with health of similar age, a test was performed to assess sensory integration in adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory integration disorders and relapses in the last year
Time Frame: 1 year
Patients with MS were divided into two groups, with relapses in the last year and without relapses. In each group, ters were performed to assess sensory integration in adults. To study SI disorders, the Daniel Travis questionnaire was used to study SI disorders in people over 18 years of age based on the guidelines of the American Society of SI Disorders in Adults. The following domains were distinguished: general sensory processing (OP, 9 items), sensory hypersensitivity (NS, 26 items), hypersensitivity / sensory exploration (PS, 20 items), sensory discrimination (DS, 26 items), motor skills (ZM, 19 items ) and socio-emotional disorders (SE, 22 items). Each symptom was assessed by the participant on a 5-point Likert scale from 0 (never occurred) to 4 (repeats regularly). If the problem occurred in the past, the respondent entered the letter P. The sum obtained by adding values in each of the domains indicated the severity of SI disorders in a given domain.
1 year
Sensory integration disorders and the degree of disease severity
Time Frame: 1 Day
MS patients were divided into two groups with EDSS up to 2.5 points and below. In both groups, sensory integration disorders were checked using a scale to assess sensoryintegration in adults. To study SI disorders, the Daniel Travis questionnaire was used to study SI disorders in people over 18 years of age based on the guidelines of the American Society of SI Disorders in Adults. The following domains were distinguished: general sensory processing (OP, 9 items), sensory hypersensitivity (NS, 26 items), hypersensitivity / sensory exploration (PS, 20 items), sensory discrimination (DS, 26 items), motor skills (ZM, 19 items ) and socio-emotional disorders (SE, 22 items). Each symptom was assessed by the participant on a 5-point Likert scale from 0 (never occurred) to 4 (repeats regularly). If the problem occurred in the past, the respondent entered the letter P. The sum obtained by adding values in each of the domains indicated the severity of SI disorders in a given domain.
1 Day
Comparing the test group with the control group
Time Frame: 1 Day
The results of the scale tests were compared to the sensory integration test in the test group and the control group. To study SI disorders, the Daniel Travis questionnaire was used to study SI disorders in people over 18 years of age based on the guidelines of the American Society of SI Disorders in Adults. The following domains were distinguished: general sensory processing (OP, 9 items), sensory hypersensitivity (NS, 26 items), hypersensitivity / sensory exploration (PS, 20 items), sensory discrimination (DS, 26 items), motor skills (ZM, 19 items ) and socio-emotional disorders (SE, 22 items). Each symptom was assessed by the participant on a 5-point Likert scale from 0 (never occurred) to 4 (repeats regularly). If the problem occurred in the past, the respondent entered the letter P. The sum obtained by adding values in each of the domains indicated the severity of SI disorders in a given domain.
1 Day

Collaborators and Investigators

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

Sponsor

Pomeranian Medical University Szczecin

Investigators

  • Study Chair: Wioletta Pawlukowska, dr hab., Department of Neurology, Pomeranian Medical University, Szczecin, Poland

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)

January 20, 2022

Primary Completion (ACTUAL)

May 25, 2022

Study Completion (ACTUAL)

June 27, 2022

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (ACTUAL)

July 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUM

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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