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Completed

NCT Number: NCT02688231

Task-oriented Upper Limb Training in MS

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Revalidatie en MS centrum, Overpelt, Limburg, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Task-oriented upper limb training

Other

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.

Control intervention

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2016
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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