CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Gait trainer treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01564511
NCT01564511N/ACompleted

Effects of Electromechanical Gait Trainer on Endurance, Fatigue and Daily Life Autonomy in Patients With Multiple Sclerosis: a Randomized Control Trial

Universita di Verona·interventional·Posted Mar 27, 2012·Updated Sep 12, 2016

In Brief

A clinical study evaluating Gait trainer treatment and Conventional treatment for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Multiple Sclerosis is a very disabling disorder in young adult patients leading to an important limitation in daily life activities and social participation. Among of the different causes of disability in MS patients gait impairments, fatigue and balance disorders can be considered as the main concerns. Thus, gait restoration in patients with MS is the one of the primary objective of rehabilitation and often influences whether a patient can return home or to work. Even if potentially innovative treatments like treadmill training have been proposed, nowadays the role of robotic assisted locomotion rehabilitation has not been extensively studied in patients with MS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2012
Enrollment StartNov 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.3 years ago

Interventions

Gait trainer treatmentdevice

Patients will be subjected to 40 minutes of repetitive locomotor therapy on the Gait Trainer (GTI) (Reha-Stim, Berlin, Germany), followed by 10 minutes of passive joint mobilization and stretching exercises. The first 40 min session will be divided as follow: 15 min gait training; 5 minutes at rest; 15 minutes gait training; 5 minutes at rest. The GT-I consists of a double crank and rocker gear system, composed of two footplates positioned on two bars (coupler), two rockers, and two cranks that provide the propulsion.

Conventional treatmentother

The control group will be subjected to a conventional treatment that will consist of three different sets of exercises: 1) passive joint mobilization and stretching of lower limb muscles; 2) muscle strengthening exercises; 3) gait exercises. Each set of exercises lasted 10, 15 and 15 min, respectively with 2,5 min at rest between each set for a total of 40 minutes.