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NCT Number: NCT02257606

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

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-

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

I-TRAVLE training

Other

Primary outcomes

  1. Motricity index

    Time frame: 2.5 min (pre-post)

    Random motor activity

  2. Fugl-Meyer

    Time frame: 30 min (pre-post)

    Assessment of recovery of motor function

  3. Action Research arm test

    Time frame: 15-20 min (pre-post)

    Grasp, grip, pinch, gross movement

  4. Motor Activity log

    Time frame: 45 min (pre-post)

    perceived activities of daily life

  5. Jamar handgrip strength

    Time frame: 2.5 min (pre-post)

    Handgrip strength

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Expertise Centre for digital Media
  • Interreg
  • Revalidatie & MS Centrum Overpelt
  • iMinds
  • tUL

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2014
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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