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

Multiple Sclerosis Clinical Trial

Official title:

Sensory Integration Disorders in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449574
• Other study ID #: PUM
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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