Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis

NCT02352194 | Unknown

• 1 other identifier: 14-REHABSEP
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the physical capacity of patients with multiple sclerosis and the effects of rehabilitation, encompassing physical therapy and physical activity as it is carried out in the day hospital of (the Physical and Rehabilitation Medicine department) at Garches Hospital. We will compare the results of assessments carried out before and after a standard rehabilitation program.

Conditions

Multiple Sclerosis (MS)

Keywords

Multiple Sclerosis, Physical therapy, Physical capacity, Fatigue

Outcome Measures

Primary Outcomes (1)

• Assessment of the strength and fatigue

  Assessment realised with an isokinetic dynamometer

  Within 10 weeks from the start of the rehabilitation program

Secondary Outcomes (10)

• 6 minutes walking test

  Within 10 weeks from the start of the rehabilitation program

• Evaluation of aerobic capacity during an effort test

  Within 10 weeks from the start of the rehabilitation program

• Assessment of the balance of patients

  Within 10 weeks from the start of the rehabilitation program

• Assessment of Spasticity with the Modified Ashworth Scale (MAS),

  Within 10 weeks from the start of the rehabilitation program

• 10 meters Walk test

  Within 10 weeks from the start of the rehabilitation

Study Arms (2)

Assessment

One part of this study is to quantify physical capacity of patients with Multiple sclerosis. Thirty patients will be enrolled in this study and performed assessments.

Rehabilitation

A second part of this study is to quantify the benefit of a usual rehabilitation program in the day hospital. Thirty patients will be enrolled in this study and receive rehabilitation. They will be assessed before and after the rehabilitation program (physiotherapy and physical activity)

Other: Rehabilitation

Interventions

Rehabilitation OTHER

Physiotherapy and physical activity

Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with MS since at least 3 months

You may qualify if:

• Multiple Sclerosis with EDSS ≤ 6 (Expanded Disability Status Scale)
• Patient ≥ 18 years old
• Patient able to comply with the recommended monitoring
• No relapse within the last three months
• More than six months elapsed since last medical care in day hospital
• No recent modification (six month) of medications for MS
• More than three months elapsed since last change of associated treatments (Fampyra, botulinum toxin)

You may not qualify if:

• Patients under any form of guardianship or curatorship
• Breastfeeding
• Orthopedic complications with repercussions on walking activities
• No affiliation to a social security scheme (beneficiary or assignee)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Raymond Poincaré Hospital

Garches, 92380, France

RECRUITING

Related Publications (1)

• Hameau S, Bensmail D, Roche N, Zory R. Fatigability in Patients With Multiple Sclerosis During Maximal Concentric Contractions. Arch Phys Med Rehabil. 2017 Jul;98(7):1339-1347. doi: 10.1016/j.apmr.2016.12.014. Epub 2017 Jan 25.

  PMID: 28130080 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Djamel Bensmail, MD,PhD

  Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,

  PRINCIPAL INVESTIGATOR

• Raphael Zory, PhD

  LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France

  STUDY DIRECTOR

• Sophie Hameau

  Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,

  STUDY DIRECTOR

Central Study Contacts

Djamel Bensmail, MD, PhD

CONTACT

+33147107060; djamel.bensmail@rpc.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 2, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 2, 2015

Record last verified: 2014-05

Locations

FR (1)