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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05449574
Other study ID # PUM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2022
Est. completion date June 27, 2022

Study information

Verified date June 2022
Source Pomeranian Medical University Szczecin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date June 27, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland Departmen of Neurology Szczecin Unii Lubelskiej

Sponsors (1)

Lead Sponsor Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensory integration disorders and relapses in the last 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
Primary Sensory integration disorders and the degree of disease severity 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
Primary Comparing the test group with the control group 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
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