Task-oriented Upper Limb Training in MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Task-oriented upper limb training
Control intervention
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Upper limb rehabilitation
Eligibility Criteria
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
Sites / Locations
- Revalidatie en MS centrum
- Hasselt University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
High intensity group
Low intensity group
Control group - conventional treatment
Arm Description
Outcomes
Primary Outcome Measures
Nine Hole peg test
Manual dexterity
Manual Ability Measure-36
Questionnaire about perceived ADL performance
Isometric hand grip
Isometric hand grip
Training tolerance
Questionnaire of training tolerance and possible adverse effects
pinch grip strength
pinch grip strength
Secondary Outcome Measures
Motricity Index
General isometric muscle strength
Muscle fatigue indices
Indices calculated based on a 30 seconds sustained maximal isometric hand grip contraction
Tactile sensitivity in the fingers Semmens-Weinstein monofilaments
Tactile sensitivity in the thumb and index
Rydel Seiffer Tuning fork
Vibration in the upper limb
Symbol digit modalities test
Cognitive function, processing speed
Box and block test
Manual dexterity
Action Research Arm Test
Proximal and distal upper limb function
Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)
Proximal and distal upper limb function
Virtual Peg Insertion Test
manual dexterity
Accelerometers (Actigraph)
actual upper limb performance in daily life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02688231
Brief Title
Task-oriented Upper Limb Training in MS
Official Title
Intensity Dependent Clinical Effects of a Task-oriented Upper Limb Training in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Upper limb rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity group
Arm Type
Experimental
Arm Title
Low intensity group
Arm Type
Experimental
Arm Title
Control group - conventional treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Task-oriented upper limb training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control intervention
Intervention Description
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 Outcome Measure Information:
Title
Nine Hole peg test
Description
Manual dexterity
Time Frame
8 weeks
Title
Manual Ability Measure-36
Description
Questionnaire about perceived ADL performance
Time Frame
8 weeks
Title
Isometric hand grip
Description
Isometric hand grip
Time Frame
8 weeks
Title
Training tolerance
Description
Questionnaire of training tolerance and possible adverse effects
Time Frame
daily through study compeletion
Title
pinch grip strength
Description
pinch grip strength
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Motricity Index
Description
General isometric muscle strength
Time Frame
8 weeks
Title
Muscle fatigue indices
Description
Indices calculated based on a 30 seconds sustained maximal isometric hand grip contraction
Time Frame
8 weeks
Title
Tactile sensitivity in the fingers Semmens-Weinstein monofilaments
Description
Tactile sensitivity in the thumb and index
Time Frame
8 weeks
Title
Rydel Seiffer Tuning fork
Description
Vibration in the upper limb
Time Frame
8 weeks
Title
Symbol digit modalities test
Description
Cognitive function, processing speed
Time Frame
8 weeks
Title
Box and block test
Description
Manual dexterity
Time Frame
8 weeks
Title
Action Research Arm Test
Description
Proximal and distal upper limb function
Time Frame
8 weeks
Title
Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)
Description
Proximal and distal upper limb function
Time Frame
8 weeks
Title
Virtual Peg Insertion Test
Description
manual dexterity
Time Frame
8 weeks
Title
Accelerometers (Actigraph)
Description
actual upper limb performance in daily life
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feys, Prof. dr.
Organizational Affiliation
REVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Revalidatie en MS centrum
City
Overpelt
State/Province
Limburg
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Hasselt University
City
Diepenbeek
ZIP/Postal Code
3560
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26747125
Citation
Lamers I, Maris A, Severijns D, Dielkens W, Geurts S, Van Wijmeersch B, Feys P. Upper Limb Rehabilitation in People With Multiple Sclerosis: A Systematic Review. Neurorehabil Neural Repair. 2016 Sep;30(8):773-93. doi: 10.1177/1545968315624785. Epub 2016 Jan 7.
Results Reference
background
PubMed Identifier
26213990
Citation
Severijns D, Octavia JR, Kerkhofs L, Coninx K, Lamers I, Feys P. Investigation of Fatigability during Repetitive Robot-Mediated Arm Training in People with Multiple Sclerosis. PLoS One. 2015 Jul 27;10(7):e0133729. doi: 10.1371/journal.pone.0133729. eCollection 2015.
Results Reference
background
PubMed Identifier
26202325
Citation
Feys P, Coninx K, Kerkhofs L, De Weyer T, Truyens V, Maris A, Lamers I. Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS. J Neuroeng Rehabil. 2015 Jul 23;12:60. doi: 10.1186/s12984-015-0043-3.
Results Reference
background
PubMed Identifier
25880033
Citation
Alt Murphy M, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015 Mar 11;15:29. doi: 10.1186/s12883-015-0292-6.
Results Reference
background
PubMed Identifier
25662346
Citation
Bertoni R, Lamers I, Chen CC, Feys P, Cattaneo D. Unilateral and bilateral upper limb dysfunction at body functions, activity and participation levels in people with multiple sclerosis. Mult Scler. 2015 Oct;21(12):1566-74. doi: 10.1177/1352458514567553. Epub 2015 Feb 6.
Results Reference
background
PubMed Identifier
25268997
Citation
Severijns D, Lamers I, Kerkhofs L, Feys P. Hand grip fatigability in persons with multiple sclerosis according to hand dominance and disease progression. J Rehabil Med. 2015 Feb;47(2):154-60. doi: 10.2340/16501977-1897.
Results Reference
background
PubMed Identifier
25190063
Citation
Lamers I, Cattaneo D, Chen CC, Bertoni R, Van Wijmeersch B, Feys P. Associations of upper limb disability measures on different levels of the International Classification of Functioning, Disability and Health in people with multiple sclerosis. Phys Ther. 2015 Jan;95(1):65-75. doi: 10.2522/ptj.20130588. Epub 2014 Sep 4.
Results Reference
background
PubMed Identifier
24664300
Citation
Lamers I, Feys P. Assessing upper limb function in multiple sclerosis. Mult Scler. 2014 Jun;20(7):775-84. doi: 10.1177/1352458514525677. Epub 2014 Mar 24.
Results Reference
background
PubMed Identifier
24631802
Citation
Lamers I, Kelchtermans S, Baert I, Feys P. Upper limb assessment in multiple sclerosis: a systematic review of outcome measures and their psychometric properties. Arch Phys Med Rehabil. 2014 Jun;95(6):1184-200. doi: 10.1016/j.apmr.2014.02.023. Epub 2014 Mar 13.
Results Reference
background
PubMed Identifier
24187309
Citation
Lambercy O, Fluet MC, Lamers I, Kerkhofs L, Feys P, Gassert R. Assessment of upper limb motor function in patients with multiple sclerosis using the Virtual Peg Insertion Test: a pilot study. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650494. doi: 10.1109/ICORR.2013.6650494.
Results Reference
background
PubMed Identifier
23627537
Citation
Lamers I, Timmermans AA, Kerkhofs L, Severijns D, Van Wijmeersch B, Feys P. Self-reported use of the upper limbs related to clinical tests in persons with multiple sclerosis. Disabil Rehabil. 2013;35(23):2016-20. doi: 10.3109/09638288.2013.771703. Epub 2013 Apr 29.
Results Reference
background
PubMed Identifier
23407701
Citation
Lamers I, Kerkhofs L, Raats J, Kos D, Van Wijmeersch B, Feys P. Perceived and actual arm performance in multiple sclerosis: relationship with clinical tests according to hand dominance. Mult Scler. 2013 Sep;19(10):1341-8. doi: 10.1177/1352458513475832. Epub 2013 Feb 13.
Results Reference
background
PubMed Identifier
23036010
Citation
van den Hoogen W, Feys P, Lamers I, Coninx K, Notelaers S, Kerkhofs L, Ijsselsteijn W. Visualizing the third dimension in virtual training environments for neurologically impaired persons: beneficial or disruptive? J Neuroeng Rehabil. 2012 Oct 5;9:73. doi: 10.1186/1743-0003-9-73.
Results Reference
background
PubMed Identifier
22562952
Citation
Broekmans T, Gijbels D, Eijnde BO, Alders G, Lamers I, Roelants M, Feys P. The relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis. Mult Scler. 2013 Jan;19(1):112-9. doi: 10.1177/1352458512444497. Epub 2012 May 4.
Results Reference
background
PubMed Identifier
21261965
Citation
Gijbels D, Lamers I, Kerkhofs L, Alders G, Knippenberg E, Feys P. The Armeo Spring as training tool to improve upper limb functionality in multiple sclerosis: a pilot study. J Neuroeng Rehabil. 2011 Jan 24;8:5. doi: 10.1186/1743-0003-8-5.
Results Reference
background
PubMed Identifier
31255988
Citation
Lamers I, Raats J, Spaas J, Meuleman M, Kerkhofs L, Schouteden S, Feys P. Intensity-dependent clinical effects of an individualized technology-supported task-oriented upper limb training program in Multiple Sclerosis: A pilot randomized controlled trial. Mult Scler Relat Disord. 2019 Sep;34:119-127. doi: 10.1016/j.msard.2019.06.014. Epub 2019 Jun 17.
Results Reference
derived
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Task-oriented Upper Limb Training in MS
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