How does strength training and balance training affect gait and fatigue in patients with Multiple Sclerosis? A study protocol of a randomized controlled trial

Abstract

INTRODUCTION:

Multiple sclerosis (MS) is characterized by a demyelination that results in reduced conductivity in the somatosensory nervous system, decreased muscle strength, vestibular alteration, and severe fatigue. Progressive resistance training (PRT) has proven to be a promising intervention showing a positive effect on muscle strength. Another promising intervention frequently used in neuro-rehabilitation is task specific training where also Balance and Motor Control Training (BMCT) are incorporated. Interestingly, the principles of BMCT do fundamentally contrast the principles of PRT in terms of variation in movement pattern, loading and repetitions. Consequently, knowledge of any diverse effect would be of clinical relevance.

AIM:

To evaluate the effects of PRT and BMCT on gait, balance and fatigue in persons with MS.

METHOD:

A three-armed multi-center, single-blinded cluster randomized controlled trial with two intervention groups (1. PRT of the lower extremities. 2. BMCT that challenges gait function) and a control group that receives usual care while on a waitlist for a combined PRT + BMCT intervention performed after the two interventions groups have completed their interventions. The interventions last ten weeks with two sessions per week, in groups of 3–6 participants. Number of participants is 30 per intervention – 90 in total. Primary outcome measures for gait function are the Timed 25 Foot Walk (T25FW) and the Six Spot Step Test (SSST). Secondary outcomes are fatigue, perceived gait function, temporo-spatial gait characteristics, balance and strength.

Inclusion criteria are: EDSS 2–6, SSST >8 sec and T25FW >5 sec. Exclusion: Recent attacks and ongoing intensive rehabilitation.

ANALYSIS:

The effects in the three groups are examined in a mixed effects regression analysis with group and time as fixed effects and center and patient within center as random effects. Spearman or Pearson correlation analysis will be conducted on baseline data to determine associations between the primary outcomes on gait function and the secondary outcomes on fatigue, spatial gait parameters, balance and patient reported measures.

TRIAL REGISTRATION:

The study is approved by the Regional ethical committee and registered at clinicaltrials.gov, NCT02870023.