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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02291107
• Other study ID #: LK.S P07
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2014
• Last updated: August 20, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Habilita, Ospedale di Sarnico
• Contact: Cristiano Sconza, MD
• Phone: 0354815515
• Email: cristiano.sconza[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Italy	HABILITA	Zingonia di Ciserano	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Habilita, Ospedale di Sarnico

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Beer S, Aschbacher B, Manoglou D, Gamper E, Kool J, Kesselring J. Robot-assisted gait training in multiple sclerosis: a pilot randomized trial. Mult Scler. 2008 Mar;14(2):231-6. Epub 2007 Oct 17. — View Citation

Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. — View Citation

Giesser B, Beres-Jones J, Budovitch A, Herlihy E, Harkema S. Locomotor training using body weight support on a treadmill improves mobility in persons with multiple sclerosis: a pilot study. Mult Scler. 2007 Mar;13(2):224-31. — View Citation

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. — View Citation

Pilutti LA, Lelli DA, Paulseth JE, Crome M, Jiang S, Rathbone MP, Hicks AL. Effects of 12 weeks of supported treadmill training on functional ability and quality of life in progressive multiple sclerosis: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92( — View Citation

Schwartz I, Sajin A, Moreh E, Fisher I, Neeb M, Forest A, Vaknin-Dembinsky A, Karusis D, Meiner Z. Robot-assisted gait training in multiple sclerosis patients: a randomized trial. Mult Scler. 2012 Jun;18(6):881-90. doi: 10.1177/1352458511431075. Epub 2011 — View Citation

Swinnen E, Beckwée D, Pinte D, Meeusen R, Baeyens JP, Kerckhofs E. Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. Mult Scler Int. 2012;2012:240274. doi: 10.1155/2012/240274. — View Citation

Vaney C, Gattlen B, Lugon-Moulin V, Meichtry A, Hausammann R, Foinant D, Anchisi-Bellwald AM, Palaci C, Hilfiker R. Robotic-assisted step training (lokomat) not superior to equal intensity of over-ground rehabilitation in patients with multiple sclerosis. — View Citation

Wier LM, Hatcher MS, Triche EW, Lo AC. Effect of robot-assisted versus conventional body-weight-supported treadmill training on quality of life for people with multiple sclerosis. J Rehabil Res Dev. 2011;48(4):483-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Timed 10 meter walking test (TWT)	Assessment of gait performance in terms of speed	5 weeks	No
Secondary	6 minute walking test (6MWT)	Assessment of gait performance in terms of resistance	5 weeks	No
Secondary	Tinetti Test (TT)	Assessment of balance and gait ability and the falls risk	5 weeks	No
Secondary	Functional Ambulation Categories (FAC)	Assessment of ambulation ability	5 weeks	No
Secondary	Modified Ashworth scale for lower limbs	Assessment of lower limbs spasticity	5 weeks	No
Secondary	Modified Motricity Index for lower limbs	Assessment of lower limbs motor function	5 weeks	No
Secondary	Knee extensor strength (KES)	Assessment of knee extensor strength by dynamometer measurement	5 weeks	No
Secondary	Double Time Support (DST)	kinematic parameter corresponding to the duration of the double support phase of gait cycle, calculated as [ms /%]	5 weeks	No
Secondary	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	No
Secondary	Expanded Disability Status Scale (EDSS)	Traditionally used disability scale for multiple sclerosis	5 weeks	No
Secondary	Functional Independence Measure (FIM)	Assessment of daily activities functional autonomy	5 weeks	No
Secondary	Quality of Life Index (QL Index - SF36)	Measures of health-related quality of life	5 weeks	No
Secondary	Numeric Rating Scale (NRS)	Assessment of pain	5 weeks	No