Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
Phase: NA
Conditions: Multiple Sclerosis
Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Effects  of  Robot-Assisted  Gait  Training  in  Patients  with  Multiple  Sclerosis:  A Single-Blinded
Randomized Controlled Study NCT03801473 (01.03.2020)
Study protocol and statistical analysis plan
The study was designed as a single center, single-blinded, randomized, parallel-group trial.
Participants and interventions
Patients who were admitted to the neurology and physical medicine and rehabilitation outpatient clinics of a
tertiary care hospital were randomized into two groups: Group 1 (robot-assisted gait training: RAGT) and
Group 2 (conventional rehabilitation).  All participants had an inpatient rehabilitation program for 4
weeks.  They followed a 60-minute rehabilitation program involving active and passive range of
motion  exercises,  transfer,  balance  and  coordination  training  and  upper  extremity  function
exercises. In addition to this, RAT or Conventional rehabilitation were administered to the patients
three times a week for a period of 4 weeks. Each session was performed in the morning and lasted
for 30 minutes. 
RoboGait, an automated locomotor therapy system, was used for treating the RAGT group (15). The system
composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and
biofeedback utilities. Treadmill speed was adjusted individually to make the patients feel comfortable and
was designed to simulate normal gait. Weight support was started with 40% of body weight and reduced
gradually in each session.
Participants in the Conventional rehabilitation group had physiotherapist-assisted walking exercises on
parallel bars and on the ground with aids/cane, tripod or walker. 
Outcome measures:
All evaluations were performed in the morning by an investigator blinded to the treatment allocation. The
assessments were made pre-treatment (T0), post-treatment (T1) and  3 months after the treatment (T2). 
Primary Outcomes:
Fatigue Severity Scale
Hospital Anxiety Depression Scale (HADS) 

Secondary Outcomes:
The Kurtzke Expanded Disability Status Scale (EDSS)
Functional ambulation category (FAC) 
Berg Balance Test (BBT) 
The 6-minute walk test (6MWT) 
Multiple Sclerosis Quality of Life-54 (MSQoL-54) 
Statistical Analysis: 
IBM SPSS Statistics for Windows, Version 20,0 (Armonk, NY) was employed for the data analysis.
Significance was assessed at p<0.05 level. The histogram and normality plots and Shapiro-Wilk normality
test were used to evaluate normality of the distribution. Chi-square test was performed for the categorical
data analysis. Student t test or Mann Whitney U test was applied for intergroup comparisons according to
normality of the data. Friedman test was used for intragroup analysis because the data was not normally
distributed. For pairwise comparison, Wilcoxon test with Bonferroni correction was performed. P values less
than 0.017 (0.05/3) were determined as statistical significance for post-hoc tests.