NCT05449574

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
Last Updated

July 8, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

June 29, 2022

Last Update Submit

July 4, 2022

Conditions

Keywords

multiple sclerosis;Sensory integrationrelapsesthe advancement of the disease

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

people with MS

People with MS with relapsing-remitting form

Diagnostic Test: Scale for the Assessment of 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

Interventions

In people with MS and people with health of similar age, a test was performed to assess sensory integration in adults

healthy peoplepeople with MS

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • diagnosed disorders of sensory integration
  • diagnosed with Ms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmen of Neurology

Szczecin, Unii Lubelskiej, 71-228, Poland

Location

MeSH Terms

Conditions

Multiple SclerosisRecurrence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wioletta Pawlukowska, dr hab.

    Department of Neurology, Pomeranian Medical University, Szczecin, Poland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 8, 2022

Study Start

January 20, 2022

Primary Completion

May 25, 2022

Study Completion

June 27, 2022

Last Updated

July 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations