Standardized Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

Intervention name(s): Early treatment group; Late treatment group
Intervention type(s): Other; Other
Intervention description(s): Physical- and occupational Therapy; Waiting list - then Physical- and occupational Therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Standardized; Physical therapy; occupational therapy; quality of life; disability; activities of daily living; ambulatory therapy; multiple sclerosis