Standardized Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis ("MS-Fit")

Standardized Comprehensive Two-month Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis: a Randomized-controlled Trial

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) and the most common cause of non-traumatic disability in young adults in western countries. Despite increasing therapeutic options to ameliorate the disease course, most patients suffer from persistent neurological deficits over time.

Disability in MS has a negative impact on patients life's impairing activities of daily living (ADL) and quality of life (QoL) and leading to loss of work and the need providing care. This results in tremendous socioeconomic burden.

Disease-modifying treatments prevent disability progression in variable extent. However no drugs are available ameliorate persistent disability in MS. Therefore, exercise training as well as physical and occupational therapies are important in the symptomatic treatment of MS.

Physical and occupational therapy is usually performed close to patients home by therapist with different professional background in a non-standardized way.

The investigators therefore aim to develop a standardized comprehensive ambulatory neurorehabilitation program, integrating task oriented circuit training for MS patients to improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital settings.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Early treatment group; Other: Late treatment group

Detailed Description

Background

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) and the most common cause of non-traumatic disability in young adults in western countries. The incidence of MS is low in childhood and increases after the age of 18, reaching a peak between 20 and 40 years (mean age of 30 years) with women being affected approximately 2-5 years earlier than men. In Switzerland the incidence is thought to be 4:100.000 with approximately 12.500 affected patients.

Despite increasing therapeutic options to ameliorate the disease course, most patients suffer from persistent neurological deficits over time.

Neurologic symptoms can be manifold and are highly variable amongst patients. They include loss of vision, sensorimotor defects, impaired manual dexterity, ataxia, apraxia, gait disturbances, bladder- and bowl problems, fatigue, cognitive dysfunctions and others, which alone, or in combination, lead to disability in MS patients. Disability in MS has a negative impact on patients life's impairing activities of daily living (ADL) and quality of life (QoL) and leading to loss of work and the need providing care. This results in tremendous socioeconomic burden.

Disease-modifying treatments prevent disability progression in variable extent. However no drugs are available ameliorate persistent disability in MS. Therefore, exercise training as well as physical and occupational therapies are important in the symptomatic treatment of MS. Intensive task oriented circuit training has been shown to be effective in stroke improving gait, and several ADL. Some pilot randomized controlled trials in MS demonstrated exercise training being able to improve muscular strength, aerobic capacity and ambulatory performance as well as fatigue, balance and gait. Furthermore, specific therapies improve manual dexterity, coordination and mobilization in MS patients as well. Although, so far no randomized trial has been done to prove the effectiveness of task oriented circuit training in MS.

Physical and occupational therapy is usually performed close to patients home by therapist with different professional background in a non-standardized way.

The investigators therefore aim to develop a standardized comprehensive ambulatory neurorehabilitation program, integrating task oriented circuit training for MS patients to improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital settings.

Objective

To evaluate the impact of a standardized comprehensive ambulatory neurorehabilitation program on disability in patients with multiple sclerosis measured by performance based test of the upper and lower extremities and by patient recorded outcome measures regarding functioning of the upper and lower extremities, activities of daily living and quality of life.

The investigators hypothesize that this training program will improve disability, activities of daily living and quality of live in MS patients.

Methods

Prospective double center, randomized, cross-over study. Consecutive MS patients that complain about disability that affects ADL and/or QoL will be recruited to participate in a comprehensive ambulatory neurorehabilitation program. Afterwards baseline measurements will be performed and patients will be randomized 1:1 into the early treatment group or the delayed treatment group in groups of four using sealed envelopes. The early treatment group starts the neurorehabilitation program whereas in the delayed treatment group, patients will be put on a waiting list for two months. After two months, outcome measurements will be collected. Patients of the early treatment group stop the neurorehabilitation program and patients of the delayed treatment group start the neurorehabilitation program for two months ("cross-over design"). Two months after ending the program, each group will be retested.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Neurology, Bern University Hospital
  • Luzern, Switzerland, 6000
    • Department of Neurology, Cantonal hospital Luzern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS)
• Age between 18 and 75 years
• Written informed consent
• Patient complains about MS related disability that affects ADL and/or QoL

Exclusion Criteria:

• A relapse that started within 60 days prior to screening
• Rapidly progressive disease
• Any disease/condition that causes neurological deficits or disability besides MS
• A history of drug abuse in the 12 months prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neurorehabilitation program; Standardized comprehensive ambulatory neurorehabilitation program	Other: Early treatment group; Physical- and occupational Therapy
Placebo Comparator: Waiting list	Other: Late treatment group; Waiting list - then Physical- and occupational Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS-29)	The Multiple Sclerosis Impact Scale (MSIS-29) is valid and reliable (ICC 0.80 - 0.87) in measuring the impact of MS on ADL.It contains 29 items comprising to a physical (MSIS-29 physical) and psychological impact scale (MSIS-29 psychological). All items are scored from 'not at all' to 'extremely' on a five-point Likert scale.	2 - 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Coin Rotation Task (Heldner et al. 2014)	The Coin Rotation Task (CRT) has been validated in assessing manual dexterity in patients with MS. Patients had to rotate a 50 Swiss Rappen coin (corresponding to a dime or 2-cent Euro coin) as fast as possible between their thumb, index and middle finger. The time to perform 20 half turns was measured twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was taken.	0 - 2 - 4 months
Change from baseline in Timed Up and Go (TUG) (Nilsagard et al. 2007)	The Timed Up and Go test (TUG) is a test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down.	0 - 2 - 4 months
Change from baseline in Nine-hole-Peg Test (NHPT) (Gookin et al. 1988)	The Nine Hole Peg Test (9HPT) is reliable (ICC values 0.80-0.99), valid and sensitive in detecting impaired dexterity in patients with MS. Patients were seated at a table with a shallow container holding nine pegs and a plastic block with nine empty holes. All pegs had to be put one at a time into the holes and then removed again one at a time into the shallow container. The time to complete the task was recorded twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was taken.	0 - 2 - 4 months
Change from baseline in 25-Foot Walk Test (25-FWT) (Cohen et al. 2014)	The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.	0 - 2 - 4 months
Change from baseline in EDSS		0 - 2 - 4 months
Change from baseline in Rand 36	The RAND-36 is a license free version of the Short-Form Health Survey-36 (SF-36) containing eight scales.15 Each scale comprises two to ten items, and makes up to two summary measures. The scales measuring "physical functioning", "role-physical", "bodily pain" and "general health" form the "physical health summary score". The scales measuring "vitality", "social functioning", "role-emotional" and "mental health" form the "mental health summary score".	0 - 2 - 4 months
Change from baseline in Fatigue Severity Scale		0 - 2 - 4 months

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Christian P Kamm, MD, Department of Neurology, Cantonal hospital Luzern

Publications and helpful links

General Publications

• Kamm CP, Uitdehaag BM, Polman CH. Multiple sclerosis: current knowledge and future outlook. Eur Neurol. 2014;72(3-4):132-41. doi: 10.1159/000360528. Epub 2014 Jul 30.
• Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. How responsive is the Multiple Sclerosis Impact Scale (MSIS-29)? A comparison with some other self report scales. J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1539-43. doi: 10.1136/jnnp.2005.064584.
• Motl RW, Pilutti LA. The benefits of exercise training in multiple sclerosis. Nat Rev Neurol. 2012 Sep;8(9):487-97. doi: 10.1038/nrneurol.2012.136. Epub 2012 Jul 24.
• Lehmann I, Thaler I, Luder G, Damm U, Walti C, Steinheimer S, Verra ML, Muri RM, Nyffeler T, Vanbellingen T, Kamm CP. Standardized, comprehensive, hospital-based circuit training in people with multiple sclerosis: results on feasibility, adherence and satisfaction of the training intervention. Eur J Phys Rehabil Med. 2020 Jun;56(3):279-285. doi: 10.23736/S1973-9087.20.06191-2. Epub 2020 Mar 30.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 26, 2019
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; activities of daily living; multiple sclerosis; Physical therapy; occupational therapy; disability; Standardized; ambulatory therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2015_04_29