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Task-oriented Upper Limb Training in MS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02688231
Enrollment
21
Registered
2016-02-23
Start date
2016-01-31
Completion date
2018-03-31
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Upper limb rehabilitation

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.

Interventions

OTHERTask-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.

OTHERControl 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.

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Training tolerancedaily through study compeletionQuestionnaire of training tolerance and possible adverse effects
pinch grip strength8 weekspinch grip strength
Nine Hole peg test8 weeksManual dexterity
Manual Ability Measure-368 weeksQuestionnaire about perceived ADL performance
Isometric hand grip8 weeksIsometric hand grip

Secondary

MeasureTime frameDescription
Box and block test8 weeksManual dexterity
Action Research Arm Test8 weeksProximal and distal upper limb function
Motricity Index8 weeksGeneral isometric muscle strength
Virtual Peg Insertion Test8 weeksmanual dexterity
Accelerometers (Actigraph)8 weeksactual upper limb performance in daily life
Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)8 weeksProximal and distal upper limb function
Muscle fatigue indices8 weeksIndices calculated based on a 30 seconds sustained maximal isometric hand grip contraction
Tactile sensitivity in the fingers Semmens-Weinstein monofilaments8 weeksTactile sensitivity in the thumb and index
Rydel Seiffer Tuning fork8 weeksVibration in the upper limb
Symbol digit modalities test8 weeksCognitive function, processing speed

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026