RedCord in Neurogenic Bowel Dysfunction in Multiple Sclerosis

NCT06838624 | Not Yet Recruiting DMC

• 1 other identifier: CLirio07
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effectiveness of Redcord treatment for neurogenic bowel dysfunction in patients with multiple sclerosis. The main objectives are:

• Assess the impact of Redcord on bowel function and quality of life in multiple sclerosis patients.
• Compare the outcomes of Redcord treatment with standard care practices. Participants will undergo Redcord therapy sessions and their bowel function will be monitored and compared to a control group receiving standard care. The study will measure improvements in bowel control, frequency, and overall patient satisfaction.

Conditions

Multiple Sclerosis; Pelvic Floor Disorder

Keywords

Multiple Sclerosis; Constipation; Faecal Incontinence; Pelvic Floor; Abdominal Muscles

Outcome Measures

Primary Outcomes (1)

• Neurogenic Bowel Dysfunction score (NBDS)

  Improvement in bowel control, measured by the Neurogenic Bowel Dysfunction Score (NBD Score) over a period of 24 weeks. Neurogenic Bowel Dysfunction score (NBDS) validated in Spanish is a questionnaire used for the clinical evaluation of colorectal and anal dysfunction. It is used to assess bowel dysfunction in neurological pathologies. It quantifies the severity of bowel dysfunction in 4 categories: very mild (score 0 to 6), mild (score 7 to 9), moderate (score 10 to 13) and severe (score greater than or equal to 14). It consists of 10 items relating to frequency of bowel movements, presence of headache and/or sweating during defecation, use of medication for constipation, time used for each defecation, frequency of bowel movements by digital extraction, frequency of faecal incontinence, medication used for faecal incontinence, presence of anal incontinence, skin problems in the peri-anal area.

  baseline, 6, 12 and 24 weeks

Secondary Outcomes (1)

• Electromyography: Root mean square

  baseline, 6, 12 and 24 weeks

Study Arms (2)

Redcord exercises

EXPERIMENTAL

The participant in this group will attend physiotherapy twice a week, every other day to avoid the onset of fatigue, for 6 weeks. In each physiotherapy session they will perform exercises in different plank positions using RedCord®, which is a tool with which exercises are performed in suspension and on an unstable base.

Device: Redcord

Standard exercises

ACTIVE COMPARATOR

The participant in this group will attend physiotherapy twice a week, every other day to avoid the onset of fatigue, for 6 weeks. In each physiotherapy session they will perform the same exercises as the intervention group, but on a stable basis.

Other: Control (Standard treatment)

Interventions

Redcord DEVICE

Perticipants will perform exercises in different plank positions using RedCord® while applying local vibration in: * Supine plank position * Prone plank position * Lateral prone plank position

Redcord exercises

Control (Standard treatment) OTHER

Participants will perform exercises in different plank positions: Supine plank position Prone plank position Lateral prone plank position

Standard exercises

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• People diagnosed with Multiple Sclerosis according to McDonald's criteria.
• EDSS less than 6 points.
• Willingness to participate.

You may not qualify if:

• People with cognitive impairment, which makes it difficult to understand the questionnaires properly.
• Pregnant women.
• Severe psychological or psychiatric pathology diagnosed.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla La Macha

Toledo, Toledo, 45001, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Pelvic Floor Disorders; Constipation; Encopresis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Central Study Contacts

Cristina Lirio-Romero, PhD

CONTACT

600320518; cristina.lirio@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. It is not possible to blind the participants or the physiotherapist who will carry out the interventions; however, the researcher in charge of conducting the pre-treatment, post-treatment and follow-up assessments, and the data analyst will be blinded. To preserve the blindness of the evaluators and analyst, a data coding table will be used to which only the principal investigator will have access.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)