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Clinical Trials/NCT02688231
NCT02688231
Completed
Not Applicable

Intensity Dependent Clinical Effects of a Task-oriented Upper Limb Training in Multiple Sclerosis

Hasselt University2 sites in 1 country21 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Hasselt University
Enrollment
21
Locations
2
Primary Endpoint
Nine Hole peg test
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

An adequate upper limb function is crucial to independently perform Activities of Daily Living (ADL). Persons with neurological diseases often experience upper limb dysfunction. Upper limb function in Multiple Sclerosis (MS) is highly prevalent, increasing with overall disability level, while the detrimental impact on ADL is higher than in stroke, given that symptoms often occur bilaterally. In contrast to stroke, it is unknown whether similar rehabilitation principles and effect sizes apply in MS given that this progressive neurodegenerative disease is characterized by multiple lesions and atrophy of brain structures. To date, optimal therapy dosage of upper limb rehabilitation programs are not known in the MS literature neither were characteristics of responders identified.

The aim of this explorative study is to investigate the intensity dependent clinical effects of a task-oriented upper limb training in persons with MS with different upper limb disability levels.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
March 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Peter Feys

Professor

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years
  • Diagnosis of MS (McDonald criteria)
  • Progressive type of MS (primary or secondary progressive MS)
  • A score 1 or more on the performance scale: item hand function

Exclusion Criteria

  • A relapse or relapse-related treatment within the last 3 months prior to the study
  • Complete paralysis of both upper limbs
  • Marked or severe intention tremor (Fahn's tremor rating scale \> 3)
  • Other medical conditions interfering with the upper limb function (ortopaedic or rheumatoid impairment)
  • Severe cognitive or visual deficits interfering with testing and training

Outcomes

Primary Outcomes

Nine Hole peg test

Time Frame: 8 weeks

Manual dexterity

Manual Ability Measure-36

Time Frame: 8 weeks

Questionnaire about perceived ADL performance

Isometric hand grip

Time Frame: 8 weeks

Isometric hand grip

pinch grip strength

Time Frame: 8 weeks

pinch grip strength

Training tolerance

Time Frame: daily through study compeletion

Questionnaire of training tolerance and possible adverse effects

Secondary Outcomes

  • Rydel Seiffer Tuning fork(8 weeks)
  • Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)(8 weeks)
  • Accelerometers (Actigraph)(8 weeks)
  • Virtual Peg Insertion Test(8 weeks)
  • Symbol digit modalities test(8 weeks)
  • Action Research Arm Test(8 weeks)
  • Box and block test(8 weeks)
  • Motricity Index(8 weeks)
  • Muscle fatigue indices(8 weeks)
  • Tactile sensitivity in the fingers Semmens-Weinstein monofilaments(8 weeks)

Study Sites (2)

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