Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial

Robot-assisted Training on the Upper Limb in Persons With MS: an RCT

With this randomised intervention study, the investigators want to investigate the training effect of an 8 week training regime, using a robot-assisted training system in persons with MS. Besides conventional therapy, study participants in the experimental group will train 3 times per week during 30 minutes, using the haptic master. Research questions focus on the effects of additional robot assisted training on range of motion, movement quality and clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16 weeks of follow-

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: I-TRAVLE training

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index <80), age > 18 years

Exclusion Criteria:

• MS relapse or glucocorticosteroid treatment in the last month before the start of the study, upper limb paralysis (Motricity Index < 18), other sever limitations, influencing participation (cognitive, visual)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group (persons with MS); no training
Experimental: Experimental group (persons with MS); Robot-assisted training	Other: I-TRAVLE training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motricity index	Random motor activity	2.5 min (pre-post)
Fugl-Meyer	Assessment of recovery of motor function	30 min (pre-post)
Action Research arm test	Grasp, grip, pinch, gross movement	15-20 min (pre-post)
Motor Activity log	perceived activities of daily life	45 min (pre-post)
Jamar handgrip strength	Handgrip strength	2.5 min (pre-post)

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: iMinds; Revalidatie & MS Centrum Overpelt; Expertise Centre for digital Media; tUL; Interreg

Publications and helpful links

General Publications

• Feys P, Coninx K, Kerkhofs L, De Weyer T, Truyens V, Maris A, Lamers I. Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS. J Neuroeng Rehabil. 2015 Jul 23;12:60. doi: 10.1186/s12984-015-0043-3.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: July 2, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CME2011/315