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Task-oriented Upper Limb Training in MS

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ClinicalTrials.gov Identifier: NCT02688231
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Feys, Hasselt University

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Task-oriented upper limb training Other: Control intervention Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensity Dependent Clinical Effects of a Task-oriented Upper Limb Training in Multiple Sclerosis
Study Start Date : January 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High intensity group Other: Task-oriented upper limb training

Participants in the experimental groups (high-intensity and low-intensity) receive for 8 weeks, 60 min/day, 5 days/week a task-oriented upper limb rehabilitation training at a high or low intensity, respectively, instead of their regular occupational therapy hours provided in the conventional multidisciplinary rehabilitation program.

The task-oriented training involves practicing of functional daily tasks, with the intention to acquire or reacquire a skill. Most functional upper limb tasks require following essential movement components: reaching, moving, positioning, transporting, lifting the upper limb and/or an object and grasping, releasing, stabilizing, manipulating an object.

The Tagtrainer of SymbioTherapy is used to support the independent training of tasks with real objects with different sizes and weights. The Diego of Tyromotion is used in patients who require assistance (gravity support) during the performance of different upper limb tasks.


Experimental: Low intensity group Other: Task-oriented upper limb training

Participants in the experimental groups (high-intensity and low-intensity) receive for 8 weeks, 60 min/day, 5 days/week a task-oriented upper limb rehabilitation training at a high or low intensity, respectively, instead of their regular occupational therapy hours provided in the conventional multidisciplinary rehabilitation program.

The task-oriented training involves practicing of functional daily tasks, with the intention to acquire or reacquire a skill. Most functional upper limb tasks require following essential movement components: reaching, moving, positioning, transporting, lifting the upper limb and/or an object and grasping, releasing, stabilizing, manipulating an object.

The Tagtrainer of SymbioTherapy is used to support the independent training of tasks with real objects with different sizes and weights. The Diego of Tyromotion is used in patients who require assistance (gravity support) during the performance of different upper limb tasks.


Active Comparator: Control group - conventional treatment Other: Control intervention

The participants in the control group receive for 8 weeks the conventional multidisciplinary rehabilitation program (physiotherapy, occupational therapy and speech or cognitive therapy if needed).

The training sessions are scheduled for 60 min/day, 5 days/week for the duration of 8 weeks.





Primary Outcome Measures :
  1. Nine Hole peg test [ Time Frame: 8 weeks ]
    Manual dexterity

  2. Manual Ability Measure-36 [ Time Frame: 8 weeks ]
    Questionnaire about perceived ADL performance

  3. Isometric hand grip [ Time Frame: 8 weeks ]
    Isometric hand grip

  4. Training tolerance [ Time Frame: daily through study compeletion ]
    Questionnaire of training tolerance and possible adverse effects

  5. pinch grip strength [ Time Frame: 8 weeks ]
    pinch grip strength


Secondary Outcome Measures :
  1. Motricity Index [ Time Frame: 8 weeks ]
    General isometric muscle strength

  2. Muscle fatigue indices [ Time Frame: 8 weeks ]
    Indices calculated based on a 30 seconds sustained maximal isometric hand grip contraction

  3. Tactile sensitivity in the fingers Semmens-Weinstein monofilaments [ Time Frame: 8 weeks ]
    Tactile sensitivity in the thumb and index

  4. Rydel Seiffer Tuning fork [ Time Frame: 8 weeks ]
    Vibration in the upper limb

  5. Symbol digit modalities test [ Time Frame: 8 weeks ]
    Cognitive function, processing speed

  6. Box and block test [ Time Frame: 8 weeks ]
    Manual dexterity

  7. Action Research Arm Test [ Time Frame: 8 weeks ]
    Proximal and distal upper limb function

  8. Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA) [ Time Frame: 8 weeks ]
    Proximal and distal upper limb function

  9. Virtual Peg Insertion Test [ Time Frame: 8 weeks ]
    manual dexterity

  10. Accelerometers (Actigraph) [ Time Frame: 8 weeks ]
    actual upper limb performance in daily life



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688231


Locations
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Belgium
Revalidatie en MS centrum Recruiting
Overpelt, Limburg, Belgium, 3900
Contact: Bart Van Wijmeersch, Prof. dr.    +3211809100    bart.vanwijmeersch@uhasselt.be   
Hasselt University Recruiting
Diepenbeek, Belgium, 3560
Contact: Peter Feys, prof.dr.       peter.feys@uhasselt.be   
Principal Investigator: Ilse Lamers, PhD         
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Peter Feys, Prof. dr. REVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium

Publications:

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Responsible Party: Peter Feys, Professor, Hasselt University
ClinicalTrials.gov Identifier: NCT02688231     History of Changes
Other Study ID Numbers: S58587
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Peter Feys, Hasselt University:
Multiple Sclerosis
Upper limb rehabilitation

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases