Clinical trial NCT02688231: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Upper limb rehabilitation
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Nine Hole peg test
timeFrame: 8 weeks
measure: Manual Ability Measure-36
timeFrame: 8 weeks
measure: Isometric hand grip
timeFrame: 8 weeks
measure: Training tolerance
timeFrame: daily through study compeletion
measure: pinch grip strength
timeFrame: 8 weeks
Secondary outcomes:
measure: Motricity Index
timeFrame: 8 weeks
measure: Muscle fatigue indices
timeFrame: 8 weeks
measure: Tactile sensitivity in the fingers Semmens-Weinstein monofilaments
timeFrame: 8 weeks
measure: Rydel Seiffer Tuning fork
timeFrame: 8 weeks
measure: Symbol digit modalities test
timeFrame: 8 weeks
measure: Box and block test
timeFrame: 8 weeks
measure: Action Research Arm Test
timeFrame: 8 weeks
measure: Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)
timeFrame: 8 weeks
measure: Virtual Peg Insertion Test
timeFrame: 8 weeks
measure: Accelerometers (Actigraph)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Overpelt
country: Belgium
facility: Revalidatie en MS centrum
state: Limburg
city: Diepenbeek
country: Belgium
facility: Hasselt University
Study officials:
affiliation: REVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
name: Peter Feys, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.