Impact of a Tele-rehabilitation Program on People With Multiple Sclerosis

NCT07178834 | Active Not Recruiting

• 1 other identifier: PR(AG)498/2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assessing safety and the occurrence of adverse effects during tele-rehabilitation (TRHB) in people with multiple sclerosis with an EDSS score of 6.5 or lower. The main questions it aims to answer are:

• Intervention using TRHB is considered safe and without adverse effects.
• Intervention using TRHB has a high degree of self-adherence, an impact on physical activity levels and self-efficacy in exercise, and a positive effect on quality of life, mood, and perception of fatigue. Researchers will compare the tele-rehabilitation with rehabilitation based solely on physical activity recommendations. Participants will complete three weekly online rehabilitation sessions and must attend three follow-up visits.

Conditions

Multiple Sclerosis

Keywords

Telerehabilitation; Rehabilitatiton; Patient-Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events such as falls, pain, fatigue, and others that may occur.

  From enrollment to the end of treatment in week 8

Secondary Outcomes (4)

• Multiple Sclerosis Quality of Life 54

  (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

• 10 meters walking test

  (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

• 6 minute walking test

  (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

• Berg Balance Scale

  (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

Study Arms (2)

Intervention group: tele-rehabilitation

EXPERIMENTAL

This group will do online rehabilitation three times a week. Every two weeks, an assessment will be made to determine whether to increase the intensity of the exercise

Behavioral: Telerehab

Control group: physical activity recommendations

NO INTERVENTION

This group will only have access to basic recommendations for physical activity.

Interventions

Telerehab BEHAVIORAL

Adverse events are observed during online rehabilitation with computer vision technology in patients with MS.

Also known as: Telerehabilitation, Intervention group

Intervention group: tele-rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with multiple sclerosis confirmed using the 2017 McDonald criteria.
• Patients who have the technological means to conduct online sessions and the autonomy to do so.
• Patients with cognitive capacity that allows them to sign the informed consent form.
• Patients with an internet connection and a device compatible with the Rehub tele-rehabilitation platform (desktop computer, laptop, or tablet).
• EDSS level less than or equal to 6.5.

You may not qualify if:

• Participants who are currently undergoing RHB at a center.
• Participants who have undergone RHB during the two months prior to the start of the program.
• Patients with physical or mental comorbidities that may limit their participation in the rehabilitation program.

Sponsors & Collaborators

• Multiple Sclerosis Center of Catalonia: lead

Study Sites (1)

Multiple Sclerosis Center of Catalonia

Barcelona, 08035, Spain

Location

Related Publications (5)

• Yau T, McIntyre M, Chan J, Bhogal D, Andreoli A, Bayley M, Leochico CFD, Kua A, Guo M, Munce S. Adverse events associated with the delivery of telerehabilitation: A scoping review protocol. PLoS One. 2024 Feb 21;19(2):e0297908. doi: 10.1371/journal.pone.0297908. eCollection 2024.

  PMID: 38381732 RESULT

• Doherty F, Lynch P, Powell P, Monaghan K. Feasibility and effectiveness of telerehabilitation on mobility and balance function in multiple sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2024 Nov 15;466:123214. doi: 10.1016/j.jns.2024.123214. Epub 2024 Sep 4.

  PMID: 39270413 RESULT

• Xiang XM, Bernard J. Telehealth in Multiple Sclerosis Clinical Care and Research. Curr Neurol Neurosci Rep. 2021 Feb 28;21(4):14. doi: 10.1007/s11910-021-01103-4.

  PMID: 33646409 RESULT

• Harkey LC, Jung SM, Newton ER, Patterson A. Satisfacció del pacient amb la telesalud en entorns rurals: una revisió sistemàtica. Revista Internacional de Telerehabilitació. 2020;12(2):53-64. doi: 10.5195/ijt.2020.6303

  RESULT

• Fjeldstad-Pardo C, Thiessen A, Pardo G. Telerehabilitation in Multiple Sclerosis: Results of a Randomized Feasibility and Efficacy Pilot Study. Int J Telerehabil. 2018 Dec 11;10(2):55-64. doi: 10.5195/ijt.2018.6256. eCollection 2018 Fall.

  PMID: 30588276 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Edwin R Meza Murillo, Dr

  Multiple Sclerosis Center of Catalonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: September 17, 2025
• Study Start: February 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)