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

NCT ID: NCT02257606

Last Updated: 2015-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-09-30

Brief Summary

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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-

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group (persons with MS)

no training

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group (persons with MS)

Robot-assisted training

Group Type EXPERIMENTAL

I-TRAVLE training

Intervention Type OTHER

Interventions

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I-TRAVLE training

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role collaborator

Expertise Centre for digital Media

UNKNOWN

Sponsor Role collaborator

tUL

UNKNOWN

Sponsor Role collaborator

iMinds

INDUSTRY

Sponsor Role collaborator

Interreg

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Peter Feys

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 26202325 (View on PubMed)

Other Identifiers

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CME2011/315

Identifier Type: -

Identifier Source: org_study_id

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