Task-oriented Upper Limb Training in MS

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Task-oriented upper limb training
* Other: Control intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity group<br> | Other: Task-oriented upper limb training<br>* 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.<br>|
| Experimental: Low intensity group<br> | Other: Task-oriented upper limb training<br>* 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.<br>|
| Active Comparator: Control group - conventional treatment<br> | Other: Control intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Upper limb rehabilitation