Effects of Telerehabilitation-Based Pelvic Floor Muscle Training in People With Multiple Sclerosis

NCT ID: NCT04758468

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2021-11-15

Brief Summary

The effectiveness of pelvic floor muscle training on urinary incontinence and sexual function has been known for many years. However, the evaluation of its effectiveness in people with Multiple Sclerosis (MS) has recently begun and the level of evidence is limited. In addition, the applicability of pelvic floor muscle training based on telerehabilitation in the presence of a physiotherapist has not been investigated before.

The aims of this study;

1. The main aim of this study is to evaluate the feasibility and acceptability of telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist, which will be applied for the first time.

2. Another aim is to compare this method with the effects of not receiving treatment other than usual treatment or receiving home-based pelvic floor muscle training on urinary incontinence, sexual dysfunction and psychosocial outcomes.

The participants will randomly be allocated into three groups: (1) Telerehabilitation-based pelvic floor muscle training, (2) Home-based pelvic floor muscle training, and (3) Control group Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days. The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks. The control group will receive no specific training

Detailed Description

Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks, but the home-based group will follow the exercise protocol individually while the telerehabilitation-based group will follow the telerehabilitation-based under the guidance of the physiotherapist.

Exercises will be applied 3 times a day according to the specified protocol. An information leaflet will be distributed to the home exercise group. The telerehabilitation-based group will receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist individually for 2 sessions a week, the patient will do the exercises twice a day in the days of the sessions with the physiotherapist, and the remaining days will continue to do it 3 times a day like a home exercise group. The control group will not receive treatment other than their routine treatment, and the patients will be informed that they will be treated if they wish at the end of the study.

The progression in Pelvic Floor Muscle Training will be achieved by increasing the exercise volume and diversifying the positions. The assessments will be applied at baseline, 4, 8, and 12 weeks.

Conditions

Multiple Sclerosis; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telerehabilitation-based pelvic floor muscle training

Group Type: EXPERIMENTAL

Telerehabilitation-based pelvic floor muscle training

Intervention Type: BEHAVIORAL

Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days.

Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.

Home-based pelvic floor muscle training

Group Type: ACTIVE_COMPARATOR

Home-based pelvic floor muscle training

Intervention Type: BEHAVIORAL

The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks.

Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.

Control (no specific intervention)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telerehabilitation-based pelvic floor muscle training

Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days.

Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.

Intervention Type: BEHAVIORAL

Home-based pelvic floor muscle training

The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks.

Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Having been diagnosed with MS according to McDonald diagnostic criteria
• Having urinary incontinence
• EDSS score less than 8
• Have the cognitive capacity to complete the assessment and treatment protocol

Exclusion Criteria

• Pregnancy
• Pelvic surgery history
• A history of cesarean or vaginal delivery within 6 months prior to the study
• Progressive disability (1 point increase in EDSS) or attacks in the last 3 months
• Having received pelvic floor muscle training in the last 6 months
• Have had or are receiving treatment for pelvic organ prolapse Patients receiving pharmacological therapy for incontinence whose dose has not changed over the past 3 months will be included, but will be excluded if the dose changes during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Turhan Kahraman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, Inciralti, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yavas I, Kahraman T, Sagici O, Ozdogar AT, Yigit P, Baba C, Ozakbas S. Feasibility of Telerehabilitation-Based Pelvic Floor Muscle Training for Urinary Incontinence in People With Multiple Sclerosis: A Randomized, Controlled, Assessor-Blinded Study. J Neurol Phys Ther. 2023 Oct 1;47(4):217-226. doi: 10.1097/NPT.0000000000000448. Epub 2023 Jun 12.

Reference Type: DERIVED

PMID: 37306430 (View on PubMed)

Other Identifiers

5742-GOA

Identifier Type: -

Identifier Source: org_study_id