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Search / Trial NCT01918748

Effect of I-TRAVLE Training on Arm Function in MS and Chronic Stroke Patients

Launched by HASSELT UNIVERSITY · Aug 6, 2013

Trial Information

Current as of July 21, 2025

Unknown status

Keywords

ClinConnect Summary

All tests and exercises are pain free, easy to perform, non-intrusive, and not high demanding. Subjects will have to undergo an assessment via a movement protocol as well as clinical outcome tests. In both cases the type of assessment does not differ from the normal assessment at a rehabilitation centre. The training is assisted using a robotic device called the Haptic Master (HM). The participant's arm is attached to the HM via a gimbal. The HM has a number of safety features to avoid overload on the participant's arm. Any potential risk for overload is minimised by a) careful build-up of ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Clinically diagnosed with a central paresis of the arm/hand at entry in the study, caused by a supratentorial stroke;
  • Post-stroke time more than 6 months (i.e. chronic phase after stroke);
  • Having completed their active clinical rehabilitation program
  • * Hemiparesis featuring a low to moderate proximal (shoulder and arm) muscle strength:
  • Motricity Index shoulder/arm item: minimum score of 14 and maximum 25 (out of 33), corresponding to a maximum active shoulder abduction of up to 90 degrees without resistance; and/or a minimum active shoulder anteflexion of 30 degrees and a maximum active range of motion of 120 degrees shoulder joint anteflexion which can actively be maintained for 10 seconds;
  • a fair cognitive level, i.e. being able to understand the questionnaires and measurement instructions;
  • ability to read and understand Dutch.
  • Exclusion Criteria:
  • Severe spasticity of the arm, i.e. Modified Ashworth Scale (MAS) score for the elbow and wrist flexors: each ≥ 3;
  • Severe visual impairment and/or severe cognitive impairment which may interfere with the execution of the arm-hand tasks or the measurements;
  • Severe neglect in the near extra personal space (38), established by the letter cancellation test (39) and Bell's test (quantitative evaluation, (40)) with a minimum omission score of 15% (Ferber, 2001);
  • Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test (AAT) (41);
  • Severe apraxia as measured by the apraxia test of van Heugten (42);
  • no informed consent.

About Hasselt University

Hasselt University is a prestigious research institution located in Belgium, renowned for its commitment to advancing scientific knowledge and innovation. With a strong focus on interdisciplinary research, the university actively engages in clinical trials that aim to address pressing health challenges. Leveraging a robust network of collaborations with healthcare professionals, industry partners, and research organizations, Hasselt University strives to translate research findings into practical applications that benefit patient care and public health. The institution is dedicated to maintaining the highest ethical standards and regulatory compliance in all its clinical research endeavors.

Locations

Overpelt, Limburg, Belgium

Hoensbroek, , Netherlands

Patients applied

0 patients applied

Trial Officials

Peter Feys, Doctor

Principal Investigator

University Hasselt

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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