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

Not Applicable

• Conditions: Multiple Sclerosis

• Registration Number: NCT02291107
• Lead Sponsor: Habilita, Ospedale di Sarnico

Brief Summary

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

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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-14
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Timed 25 Foot Walk (25FW)	5 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HABILITA; 🇮🇹 Zingonia di Ciserano, Bergamo, Italy

HABILITA

🇮🇹Zingonia di Ciserano, Bergamo, Italy

Paola Sabattini

Contact

0354815515

paolasabattini@habilita.it