Multiple Sclerosis Clinical Trial
Official title:
Sensory Integration Disorders in Multiple Sclerosis
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 |
Verified date | June 2022 |
Source | Pomeranian Medical University Szczecin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Departmen of Neurology | Szczecin | Unii Lubelskiej |
Lead Sponsor | Collaborator |
---|---|
Pomeranian Medical University Szczecin |
Poland,
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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