Clinical trial NCT02440516: Standardized Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis
Official title: Standardized Comprehensive Two-month Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Standardized
Physical therapy
occupational therapy
quality of life
disability
activities of daily living
ambulatory therapy
multiple sclerosis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS-29)
timeFrame: 2 - 4 months
Secondary outcomes:
measure: Change from baseline in Coin Rotation Task (Heldner et al. 2014)
timeFrame: 0 - 2 - 4 months
measure: Change from baseline in Timed Up and Go (TUG) (Nilsagard et al. 2007)
timeFrame: 0 - 2 - 4 months
measure: Change from baseline in Nine-hole-Peg Test (NHPT) (Gookin et al. 1988)
timeFrame: 0 - 2 - 4 months
measure: Change from baseline in 25-Foot Walk Test (25-FWT) (Cohen et al. 2014)
timeFrame: 0 - 2 - 4 months
measure: Change from baseline in EDSS
timeFrame: 0 - 2 - 4 months
measure: Change from baseline in Rand 36
timeFrame: 0 - 2 - 4 months
measure: Change from baseline in Fatigue Severity Scale
timeFrame: 0 - 2 - 4 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Neurology, Bern University Hospital
city: Luzern
country: Switzerland
facility: Department of Neurology, Cantonal hospital Luzern
Study officials:
affiliation: Department of Neurology, Cantonal hospital Luzern
name: Christian P Kamm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.