Supported Treadmill Training for Progressive Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional

Summary: 
      This study is a pilot trial to evaluate the effects of supported treadmill walking in
      patients with primary progressive multiple sclerosis (MS) on functional and psychosocial
      outcomes. Patients will exercise three times per week over the course of 6 months and will be
      evaluated at baseline, 12 weeks and 24 weeks into the program. Follow-up testing will also be
      conducted 12 weeks after participants have stopped exercising to determined the lasting
      effects of the intervention.

      The investigators hypothesize that supported treadmill walking will be effective at improving
      physical physical function and psychosocial outcomes in patients with primary progressive MS.
    

Detailed description: 
      The use of exercise as an adjunct to other disease modifying treatments in MS has found
      increasing support over the past decade. There is ample evidence that exercise therapy can
      improve physical measures of disability in MS, in addition to being safe and well-tolerated.
      However, there is a paucity of data on whether exercise is equally effective for those with
      primary progressive MS as it is in relapsing remitting MS. In addition, studies of exercise
      therapy have traditionally excluded MS patients with severe disability. There are also
      currently no treatments for primary progressive MS, so finding a safe disease-modifying
      therapy is of the utmost importance. The investigators are therefore conducting a pilot trial
      to evaluate the effects of exercise in the form of supported treadmill walking for patients
      with primary progressive MS with severe functional impairments.

      Six patients with primary progressive MS with high disability level will be recruited to
      participate in this study. Participants will exercise using body-weight supported treadmill
      training (BWSTT; Woodway Loco-system) which allows a portion of an individual's body-weight
      to be counterbalanced by an overhead pulley system. This system allows patients with limited
      mobility to walk upright on the treadmill with therapist assistance. Therapists trained in
      using the BWSTT system will guide the patients' legs through a proper gait motion and assist
      with lower limb control. Participants will complete 72 training sessions (30min/session,
      3x/week) over the course of 24 weeks. Participants will be evaluated at baseline, 12 weeks
      (half-way through the training program) and 24 weeks (end of intervention). A follow-up
      assessment will also be performed 12 after participants have completed the training program
      (36 weeks). Outcome measures are described below.
    

Intervention name(s): Body-weight supported treadmill training
Intervention type(s): Other
Intervention description(s): Patients will undergo training using the Woodway Loco-system which consists of a treadmill with an overhead pulley system connected to a support harness. BWSTT allows patients with limited mobility to safely walk upright on a treadmill with a portion of their body weight counter balanced. Three trainers will be required to assist with the BWSTT program. Two trainers will be positioned at the lower limbs to manually guide the participant through a proper gait motion and provided lower limb control. A third trainer will stand behind the participant to provide trunk support and assist with weight shifting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: treadmill exercise; rehabilitation; progressive multiple sclerosis; functional ability; quality of life; fatigue