Task-oriented Upper Limb Training in MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Task-oriented upper limb training; Other: Control intervention

• Registration Number: NCT02688231
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low intensity group	Task-oriented upper limb training	-
Control group - conventional treatment	Control intervention	-
High intensity group	Task-oriented upper limb training	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Revalidatie en MS centrum; 🇧🇪 Overpelt, Limburg, Belgium

Hasselt University; 🇧🇪 Diepenbeek, Belgium