NCT05541965

Brief Summary

The research was carried out as experiment, control group, pretest-posttest model and single-blind. The population of the study consisted of MS patients who applied to OMU (Ondokuz Mayıs University) Neurology Service and Neurology Outpatient Clinic between March 2020 and February 2022. Fifteen patients who met the inclusion criteria were included in the study. Patients were divided into reflexology, pelvic floor muscle exercise and control groups. The control group was not intervened, only data collection tools were applied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2020

Typical duration for not_applicable multiple-sclerosis

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

May 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

September 9, 2022

Last Update Submit

July 29, 2025

Conditions

Multiple SclerosisReflexologyUrinary Incontinence

Keywords

Multiple sclerosisNursesComplementary TherapiesUrinary IncontinenceReflexology

Outcome Measures

Primary Outcomes (3)

  • Index of severity incontinence (ISI)

    The total score is between 0-12. A score of "0" indicates that there is no incontinence. The scale score is then categorized into 4 different levels of incontinence severity: 1-2: mild, 3-6: moderate, 8-9: severe, 10-12: very serious.

    4 weeks

  • nternational Consultation on Incontinence Questionnaire Short Form(ICIQ-SF)

    The scores that can be obtained from the scale range from 0 to 21; A low score indicates that urinary incontinence has little effect on quality of life, while a high score indicates that it affects the quality of life very much.

    4 weeks

  • Incontinence quality of life (IQOL)

    The total score ranges from 0 to 100. High scores indicate better quality of life than low scores.

    4 weeks

Study Arms (3)

Median score distributions of the reflexology groups, ICIQ-SF, IQOL and ISI

EXPERIMENTAL
Other: Reflexology and kegel exercises

Median score distributions of the kegel groups, ICIQ-SF, IQOL and ISI

ACTIVE COMPARATOR
Other: Reflexology and kegel exercises

Median score distributions of the control groups, ICIQ-SF, IQOL and ISI

ACTIVE COMPARATOR
Other: Reflexology and kegel exercises

Interventions

Reflexology and kegel exercisesOTHER

Reflexology is specific to a foot massage, and ıt can use different symptoms for patients. Kegel exercise is specific an activities and ıt can used for urinary incontinence

Median score distributions of the control groups, ICIQ-SF, IQOL and ISIMedian score distributions of the kegel groups, ICIQ-SF, IQOL and ISIMedian score distributions of the reflexology groups, ICIQ-SF, IQOL and ISI

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with MS at least 6 months ago,
  • Having an EDSS of \<5,

You may not qualify if:

  • To have wound on foots, varicose veins, etc. history of fractures causing loss of function, nail fungus,
  • pregnancy,
  • presence of acute infection
  • To using any diuretic or incontinence medication,
  • To have a curettage or pregnancy history in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afitap ÖZDELİKARA

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisUrinary Incontinence

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 15, 2022

Study Start

May 1, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

TU(1)