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

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ClinicalTrials.gov Identifier: NCT02291107
Recruitment Status : Unknown
Verified August 2015 by Dr. Cristiano Sconza, Habilita, Ospedale di Sarnico.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Cristiano Sconza, Habilita, Ospedale di Sarnico

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date August 21, 2015
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
Timed 25 Foot Walk (25FW) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
  • Timed 10 meter walking test (TWT) [ Time Frame: 5 weeks ]
    Assessment of gait performance in terms of speed
  • 6 minute walking test (6MWT) [ Time Frame: 5 weeks ]
    Assessment of gait performance in terms of resistance
  • Tinetti Test (TT) [ Time Frame: 5 weeks ]
    Assessment of balance and gait ability and the falls risk
  • Functional Ambulation Categories (FAC) [ Time Frame: 5 weeks ]
    Assessment of ambulation ability
  • Modified Ashworth scale for lower limbs [ Time Frame: 5 weeks ]
    Assessment of lower limbs spasticity
  • Modified Motricity Index for lower limbs [ Time Frame: 5 weeks ]
    Assessment of lower limbs motor function
  • Knee extensor strength (KES) [ Time Frame: 5 weeks ]
    Assessment of knee extensor strength by dynamometer measurement
  • Double Time Support (DST) [ Time Frame: 5 weeks ]
    kinematic parameter corresponding to the duration of the double support phase of gait cycle, calculated as [ms /%]
  • Step Length Ratio (SLR) [ Time Frame: 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)
  • Expanded Disability Status Scale (EDSS) [ Time Frame: 5 weeks ]
    Traditionally used disability scale for multiple sclerosis
  • Functional Independence Measure (FIM) [ Time Frame: 5 weeks ]
    Assessment of daily activities functional autonomy
  • Quality of Life Index (QL Index - SF36) [ Time Frame: 5 weeks ]
    Measures of health-related quality of life
  • Numeric Rating Scale (NRS) [ Time Frame: 5 weeks ]
    Assessment of pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robot-assisted Gait Training in Patients With Multiple Sclerosis: Efficacy and Comparison With Traditional Methods
Official Title  ICMJE Robot-assisted Gait Training in Patients Affected by Multiple Sclerosis: Rehabilitative Efficacy Evaluation and Comparison With Traditional Methods
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Device: Lokomat (Hocoma, Zurich, Switzerland)
    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.
  • Other: Conventional Physiotherapy
    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.
Study Arms  ICMJE
  • Experimental: Experimental group
    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
    Intervention: Device: Lokomat (Hocoma, Zurich, Switzerland)
  • Active Comparator: Control group
    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
    Intervention: Other: Conventional Physiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2014)
17
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291107
Other Study ID Numbers  ICMJE LK.S P07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Cristiano Sconza, Habilita, Ospedale di Sarnico
Study Sponsor  ICMJE Habilita, Ospedale di Sarnico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Umberto Bonassi, MD HABILITA Zingonia
Principal Investigator: Cristiano Sconza, MD HABILITA Zingonia
PRS Account Habilita, Ospedale di Sarnico
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP