Task-oriented Upper Limb Training in MS

May 2, 2019 updated by: Peter Feys, Hasselt University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Diepenbeek, Belgium, 3560
        • Hasselt University
    • Limburg
      • Overpelt, Limburg, Belgium, 3900
        • Revalidatie en MS Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nine Hole peg test
Time Frame: 8 weeks
Manual dexterity
8 weeks
Manual Ability Measure-36
Time Frame: 8 weeks
Questionnaire about perceived ADL performance
8 weeks
Isometric hand grip
Time Frame: 8 weeks
Isometric hand grip
8 weeks
Training tolerance
Time Frame: daily through study compeletion
Questionnaire of training tolerance and possible adverse effects
daily through study compeletion
pinch grip strength
Time Frame: 8 weeks
pinch grip strength
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motricity Index
Time Frame: 8 weeks
General isometric muscle strength
8 weeks
Muscle fatigue indices
Time Frame: 8 weeks
Indices calculated based on a 30 seconds sustained maximal isometric hand grip contraction
8 weeks
Tactile sensitivity in the fingers Semmens-Weinstein monofilaments
Time Frame: 8 weeks
Tactile sensitivity in the thumb and index
8 weeks
Rydel Seiffer Tuning fork
Time Frame: 8 weeks
Vibration in the upper limb
8 weeks
Symbol digit modalities test
Time Frame: 8 weeks
Cognitive function, processing speed
8 weeks
Box and block test
Time Frame: 8 weeks
Manual dexterity
8 weeks
Action Research Arm Test
Time Frame: 8 weeks
Proximal and distal upper limb function
8 weeks
Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)
Time Frame: 8 weeks
Proximal and distal upper limb function
8 weeks
Virtual Peg Insertion Test
Time Frame: 8 weeks
manual dexterity
8 weeks
Accelerometers (Actigraph)
Time Frame: 8 weeks
actual upper limb performance in daily life
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S58587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Task-oriented upper limb training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe