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

NCT02291107 | Unknown DMC

• 1 other identifier: LK.S P07
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Gait orthosis; Lokomat; Robotic Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Timed 10 meter walking test (TWT)

  5 weeks

• 6 minute walking test (6MWT)

  5 weeks

• Tinetti Test (TT)

  5 weeks

• Functional Ambulation Categories (FAC)

  5 weeks

• Modified Ashworth scale for lower limbs

  5 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

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

Interventions

Lokomat (Hocoma, Zurich, Switzerland) DEVICE

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.

Experimental group

Conventional Physiotherapy OTHER

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.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Habilita, Ospedale di Sarnico: lead

Study Sites (1)

HABILITA

Zingonia Di Ciserano, Bergamo, 24040, Italy

RECRUITING

Related Publications (9)

• 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 Dec 6.

  PMID: 22146609 RESULT

• 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. doi: 10.1177/1352458507082358. Epub 2007 Oct 17.

  PMID: 17942510 RESULT

• 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.

  PMID: 18971381 RESULT

• Swinnen E, Beckwee 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. Epub 2012 May 30.

  PMID: 22701177 RESULT

• 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. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):212-21. doi: 10.1177/1545968311425923. Epub 2011 Dec 2.

  PMID: 22140197 RESULT

• 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. doi: 10.1682/jrrd.2010.03.0035.

  PMID: 21674396 RESULT

• 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(1):31-6. doi: 10.1016/j.apmr.2010.08.027.

  PMID: 21187202 RESULT

• 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. doi: 10.1177/1352458506070663.

  PMID: 17450642 RESULT

• Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.

  PMID: 12732691 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Umberto Bonassi, MD

  HABILITA Zingonia

  STUDY CHAIR

• Cristiano Sconza, MD

  HABILITA Zingonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiano Sconza, MD

CONTACT

0354815515; cristiano.sconza@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

IT (1)