Effects of Electromechanical Gait Trainer in Patients With Multiple Sclerosis

NCT ID: NCT01564511

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-12-31

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.

Detailed Description

Background Multiple sclerosis (MS) is the most common chronic disabling disease of the central nervous system in young adults. Gait disorders represent one of the greatest causes of disability in patients with MS. 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.

Despite significant progress in the development of disease-modifying drugs, pharmacologic therapy alone does not warrant optimal care in MS. Exercise has been recognized as a feasible form of self-management for persons with the disease. Regular exercise can improve daily activity, cardiovascular fitness, muscle strength, health perception, and reduce fatigue in patients with MS.

To restore gait, modern concepts of rehabilitation support a repetitive task-specific approach. In recent years it has also been shown that higher intensities of walking practice (resulting in more repetitions trained) result in better outcomes for patients after stroke. Recently, the introduction of robotic devices for gait rehabilitation have showed to be a feasible approach in order to improve gait ability in patients with stroke and spinal cord lesions. These devices allow to train patients under a graduated body weight support condition and to guide the patient's steps reproducing a physiologic gait pattern for as long as the clinical conditions allow. This activity can be executed requiring only supervision by a physiotherapist and in absolutely safety condition for the patient.

Repetitive locomotor training is an innovative approach in gait disturbances in patients with multiple sclerosis. Only scant data on this issue is available and all these studies have been performed by means of conventional physiotherapy or treadmill training approaches. Nowadays the effectiveness of robotic devices for gait rehabilitation has not yet been evaluated in patients with multiple sclerosis.

Aim of the study The aim of the study is to evaluate the effect of a repetitive locomotor training by electromechanical gait trainer on gait endurance, fatigue and activities daily life in patients with MS.

Study Design Randomised controlled, blinded clinical trial. Materials and methods Fifty patients with definite diagnosis of MS according to McDonald criteria, and with EDSS score equal to or below 7 will be enrolled in the study. Patients with disease recurrence that worsens significantly during the 8 weeks before recruitment will be excluded. At the moment of recruitment (before treatment), at the end of treatment (6 weeks) and one month after the end of the treatment (FU) each patient will be tested with the following clinical and instrumental procedures. Clinical assessment procedures: 6-minute Walking Test, 10-meter Walking Test, Fatigue Severity Scale, Multiple Sclerosis Quality Of Life-54, Hamilton Rating Scale for Depression, Falls Efficacy Scale. Instrumental assessment procedures: GAITRite® System, Stabilometric Assessment and measure of energy cost by COSMED K4b2.

As primary outcome measure will be considered the 6-minute Walking Distance Test. As secondary outcomes measures will be considered the 10-meter Walking Test, Fatigue Severity Scale and the Multiple Sclerosis Quality Of Life-54, Hamilton Rating Scale for Depression, Falls Efficacy Scale, Spatio-temporal parameter with GAITRite® System, Stabilometric Assessment and measure of energy cost by COSMED K4b2. The allocation in the two groups will be done with simple randomisation.

Patients will be randomized into two groups. The first group (experimental group) will be subjected to 12 treatment session (2 sessions/week) on Gait Trainer machine. The second group (control group) will undergo to a conventional treatment with the same duration and frequency of the experimental group. Data will be analysed by means parametric and non-parametric tests. Both, within and between groups comparison will be performed. Data will be analyzed using SPSS software (ver 11.0; SPSS Inc., Chicago, IL, USA). Expected results: we could hypothesize that the training performed by the experimental group could improve gait endurance and daily life disability in patients with MS.

Conditions

Relapsing-Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gait trainer treatment

Roboti gait training by mean of Gangtrainer I

Group Type: EXPERIMENTAL

Gait trainer treatment

Intervention Type: 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.

Conventional group

Convetional physical gait training

Group Type: SHAM_COMPARATOR

Conventional treatment

Intervention Type: 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.

Interventions

Gait trainer treatment

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.

Intervention Type: DEVICE

Conventional treatment

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. age between 30 and 60 years

2. Expanded Disability Status Scale (EDSS) score 2.0≥ x ≤ 4.0

3. Mini Mental State Evaluation (MMSE) score ≥ 24

4. absence of heart problems

5. ability to maintain standing position without aids for at least 1 minute

6. ability to walk independently for at least 15 metres

7. absence of concurrent neurological or orthopaedic diseases that interfere with deambulation.

Exclusion Criteria

1. disease recurrence that worsens significantly during the 3 months prior to recruitment

2. pharmacological therapy not well defined

3. performance of any type of rehabilitation treatment in the month prior to recruitment

4. presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Nicola Smania, MD, Clinical Professor

Prof. Smania Nicola

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Fiaschi, Professor

Role: STUDY_CHAIR

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

Locations

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

Verona, Verona, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 18971381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17213237 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19156023 (View on PubMed)

Other Identifiers

GT&SM-01

Identifier Type: -

Identifier Source: org_study_id