Effects of Electromechanical Gait Trainer in Patients With Multiple Sclerosis

NCT01564511 | Completed DMC

• 1 other identifier: GT&SM-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Robotic Rahabilitation; Fatigue; Gait disorder

Outcome Measures

Primary Outcomes (1)

• 6-minute Walking Test

  This is a validated test for the clinical evaluation of walking endurance using in patient with MS. It involves respiratory, cardiovascular, skeletal, nervous and muscular system competences/skills (32). The patient will be asked to walk at her/his self-selected walking speed in the gym along during the instrumental test.

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

Secondary Outcomes (6)

• 10-meter Walking Test

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

• Falls efficacy scale score

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

• Spatio-temporal gait analysis

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

• Static balance assessment

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

• Measure of energy cost

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

Study Arms (2)

Gait trainer treatment

EXPERIMENTAL

Roboti gait training by mean of Gangtrainer I

Device: Gait trainer treatment

Conventional group

SHAM COMPARATOR

Convetional physical gait training

Other: Conventional treatment

Interventions

Gait trainer treatment DEVICE

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.

Gait trainer treatment

Conventional treatment OTHER

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.

Conventional group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 30 and 60 years
• Expanded Disability Status Scale (EDSS) score 2.0≥ x ≤ 4.0
• Mini Mental State Evaluation (MMSE) score ≥ 24
• absence of heart problems
• ability to maintain standing position without aids for at least 1 minute
• ability to walk independently for at least 15 metres
• absence of concurrent neurological or orthopaedic diseases that interfere with deambulation.

You may not qualify if:

• disease recurrence that worsens significantly during the 3 months prior to recruitment
• pharmacological therapy not well defined
• performance of any type of rehabilitation treatment in the month prior to recruitment
• presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

S.S.O. di Riabilitazione dell'Ospedale Policlinico

Verona, Verona, 37124, Italy

Location

Related Publications (3)

• Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473.

  PMID: 18971381 BACKGROUND

• Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.

  PMID: 17213237 BACKGROUND

• Benedetti MG, Gasparroni V, Stecchi S, Zilioli R, Straudi S, Piperno R. Treadmill exercise in early mutiple sclerosis: a case series study. Eur J Phys Rehabil Med. 2009 Mar;45(1):53-9.

  PMID: 19156023 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Fatigue; Mobility Limitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Fiaschi, Professor

  Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Smania Nicola

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 27, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

IT (1)