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
1 other identifier
interventional
17
0 countries
N/A
Brief Summary
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-
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-sclerosis
Started Jul 2011
Shorter than P25 for not_applicable multiple-sclerosis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedJuly 3, 2015
July 1, 2015
2 months
October 2, 2014
July 2, 2015
Conditions
Outcome Measures
Primary Outcomes (5)
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)
Study Arms (2)
Control group (persons with MS)
NO INTERVENTIONno training
Experimental group (persons with MS)
EXPERIMENTALRobot-assisted training
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index \<80), age \> 18 years
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hasselt Universitylead
- Revalidatie & MS Centrum Overpeltcollaborator
- Expertise Centre for digital Mediacollaborator
- tULcollaborator
- iMindscollaborator
- Interregcollaborator
Related Publications (1)
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.
PMID: 26202325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr.
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 6, 2014
Study Start
July 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
July 3, 2015
Record last verified: 2015-07