Robot-assisted Gait Training in Patients With Multiple Sclerosis: Efficacy and Comparison With Traditional Methods

Study Overview
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Brief Summary
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In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. Current promising rehabilitative approaches for neurological disorders are based on the concept of the task-specific repetitive training. Hence, the interest in automated robotic devices that allow this typology of treatment for gait training. However, studies on the effectiveness of such methodologies are still poorly numerous in terms of functional improvement in MS patients. The aim of this controlled cross-over study is to evaluate the effectiveness of a Lokomat gait training in patients affected by Multiple Sclerosis in comparison to a ground conventional gait training.

Detailed Description
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In Multiple Sclerosis (MS), the highly variable distribution of demyelinization areas and axonal loss in the Central Nervous System can lead to very complex and unpredictable neurological deficits and clinical patterns. Gait disorders as reduced speed and stride length, gait asymmetry, increased muscular energy expenditure, balance deficit and increased risk of falling, represent one of the most disabling aspect. These motor problems strongly influence the level of independence that a person affected by MS is able to achieve, resulting in severe negative impact on quality of life. Therefore, the improvement of walking ability is a primary goal for rehabilitation treatment. Many studies demonstrated that a conventional rehabilitation treatment based on physiotherapy could be effective in increasing muscle strength and motor function, improving gait and mobility abilities, reducing fatigue and risk of falls, leading finally to an overall increase of patient autonomy. According to the most recent neurophysiological concepts based on neural plasticity, in recent years the rehabilitative approaches that seem to be more effective in improving functional performance are based on the concept of the task-specific repetitive training. As in the case of the constraint induced movement therapy (CIMT) for upper limb rehabilitation and the body weight support treadmill training (BWSTT) for the lower, the factors that appear to positively affect patient outcome are the intensity, precocity, repeatability, specificity in a training that incorporates high numbers of repetitions of task-oriented practice. Hence, the interest in automated robotic devices for gait training for MS patients has grown. With their consistent, symmetrical lower-limb trajectories, robotic devices provide many of the proprioceptive inputs that may increase cortical activation and stimulation of Central Pattern Generator (CGPs) in order to improve motor function. The use of robot-assisted-gait-training (RAGT) allows: repetition of specific and stereotyped movements in order to acquire a correct and reproducible gait pattern in conditions of balance and symmetry, early start of treatment using the activity with body weight support, safeguard of the patient with reduction of fear of falling, in order to increase the quantity and quality of the performed exercise while minimizing the intervention of a therapist. However, studies on the effectiveness of such methodologies are still poorly numerous in terms of functional improvement in patients with MS. The aim of this controlled cross-over study is to evaluate the effectiveness of a robot-driven gait orthosis (Lokomat - Hocoma, Inc., Zurich, Switzerland) gait training in patients affected by Multiple Sclerosis in comparison to a ground conventional gait training. The improvement in gait pattern, motor ability and autonomy in the functional activities of daily living will be assessed by using validated clinical and functional scales and quantitative instrumental analysis of gait kinematic parameters

Official Title
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Robot-assisted Gait Training in Patients Affected by Multiple Sclerosis: Rehabilitative Efficacy Evaluation and Comparison With Traditional Methods

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Lokomat (Hocoma, Zurich, Switzerland)
* Other: Conventional Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of multiple sclerosis according to the McDonald's Criteria in stable phase of disease for at least 3 months. ability to walk 25 foot without assistance EDSS score between 3.5 and 7 Exclusion Criteria: exacerbations of the disease in the last 3 months deficits of somatic sensation involving the legs other neurological, orthopedic or cardiovascular co-morbility severe posture abnormalities severe-moderate cognitive impairment (Mini Mental State ≤ 21) body weight greater than 135 kg; height more than 200 cm; limb-length discrepancy greater than 2 cm; presence of skin lesions on the trunk, pelvis and lower limbs that could interfere with the placement of the electrodes and straps anchoring the Lokomat.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Participants received 25 sessions of robotically driven gait orthosis training on the Lokomat. Training occurred approximately 5 days/ week for 5 weeks, and each training session on the Lokomat lasted 30 minutes. All sessions were supervised by a trained research therapist. All participants started with 40% body weight-support and an initial treadmill speed of 1.5 km/h. Body weight-support was used primarily to facilitate an increase in walking speed; therefore, progression of training across subsequent sessions was standardized by preferentially increasing speed and then unloading body weight-support. Speed was increased to a range of 2.2 to 2.5 km/h before body weight-support was decreased. There was an active attempt to enhance the level of training at each session. After every Lokomat session, participants performed also 60 minutes of physiotherapy including general exercise program and a conventional gait training | Device: Lokomat (Hocoma, Zurich, Switzerland)<br>* Patients allocated to the Experimental group performed a Robotic Assisted Gait Training by means of the Lokomat. The Lokomat is robotic device set up as an exoskeleton on the lower limbs of the patient. The system uses a dynamic body weight-support system to support he participant above a motorized treadmill synchronized with the Lokomat.<br>|
| Active Comparator: Control group<br>Participants received 25 sessions of conventional physiotherapy. Training occurred approximately 5 days/week for 5 weeks, and each training session lasted 1 hour and half. Patients allocated to the Control Group performed the same conventional physiotherapy training of the other group: a general exercise program and a conventional gait training. The general exercise program consisted in cardiovascular warm-up exercises, muscle stretching exercises, active-assisted or active isometric and isotonic exercises for the main muscles of the trunk and limbs, relaxation exercises, coordination and static/dynamic balance exercises. The conventional gait therapy was based on the proprioceptive neuromuscular facilitation concept, training in walking on different surfaces with or without appropriate walking aids, exercises for the restoration of a correct gait pattern, implementation of residual compensatory strategies and progressive increase of walking resistance | Other: Conventional Physiotherapy<br>* Patients allocated to the Control Group performed a general exercise program and a conventional gait training. The same trained therapist treated all the patients in this group and standardized the duration of each part of the treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25 Foot Walk (25FW) | Assessment of gait performance in terms of speed. First component of the Multiple Sclerosis Functional Composite (MSCF) scale - leg function / ambulation, for the study and measurement of functional outcomes in clinical trials in patients with multiple sclerosis according to the Task Force on Clinical Outcomes Assessment of the National Multiple Sclerosis Society - 1994. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 10 meter walking test (TWT) | Assessment of gait performance in terms of speed | 5 weeks | 
| 6 minute walking test (6MWT) | Assessment of gait performance in terms of resistance | 5 weeks | 
| Tinetti Test (TT) | Assessment of balance and gait ability and the falls risk | 5 weeks | 
| Functional Ambulation Categories (FAC) | Assessment of ambulation ability | 5 weeks | 
| Modified Ashworth scale for lower limbs | Assessment of lower limbs spasticity | 5 weeks | 
| Modified Motricity Index for lower limbs | Assessment of lower limbs motor function | 5 weeks | 
| Knee extensor strength (KES) | Assessment of knee extensor strength by dynamometer measurement | 5 weeks | 
| Double Time Support (DST) | kinematic parameter corresponding to the duration of the double support phase of gait cycle, calculated as [ms /%] | 5 weeks | 
| Step Length Ratio (SLR) | kinematic parameter corresponding to gait symmetry, calculated as the ratio between the step length of both legs (shorter step length / longer step length) | 5 weeks | 
| Expanded Disability Status Scale (EDSS) | Traditionally used disability scale for multiple sclerosis | 5 weeks | 
| Functional Independence Measure (FIM) | Assessment of daily activities functional autonomy | 5 weeks | 
| Quality of Life Index (QL Index - SF36) | Measures of health-related quality of life | 5 weeks | 
| Numeric Rating Scale (NRS) | Assessment of pain | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait orthosis, Lokomat, Robotic Rehabilitation