Task-oriented Upper Limb Training in MS

NCT02688231 | Completed

• 1 other identifier: S58587
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Upper limb rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Motricity Index

  8 weeks

• Muscle fatigue indices

  8 weeks

• Tactile sensitivity in the fingers Semmens-Weinstein monofilaments

  8 weeks

• Rydel Seiffer Tuning fork

  8 weeks

• Symbol digit modalities test

  8 weeks

Study Arms (3)

High intensity group

EXPERIMENTAL

Other: Task-oriented upper limb training

Low intensity group

EXPERIMENTAL

Other: Task-oriented upper limb training

Control group - conventional treatment

ACTIVE COMPARATOR

Other: Control intervention

Interventions

Task-oriented upper limb training OTHER

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.

High intensity group; Low intensity group

Control intervention OTHER

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.

Control group - conventional treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (2)

Revalidatie en MS centrum

Overpelt, Limburg, 3900, Belgium

Location

Hasselt University

Diepenbeek, 3560, Belgium

Location

Related Publications (16)

• 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.

  PMID: 26747125 BACKGROUND

• 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.

  PMID: 26213990 BACKGROUND

• 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.

  PMID: 26202325 BACKGROUND

• 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.

  PMID: 25880033 BACKGROUND

• 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.

  PMID: 25662346 BACKGROUND

• 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.

  PMID: 25268997 BACKGROUND

• 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.

  PMID: 25190063 BACKGROUND

• 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.

  PMID: 24664300 BACKGROUND

• 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.

  PMID: 24631802 BACKGROUND

• 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.

  PMID: 24187309 BACKGROUND

• 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.

  PMID: 23627537 BACKGROUND

• 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.

  PMID: 23407701 BACKGROUND

• 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.

  PMID: 23036010 BACKGROUND

• 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.

  PMID: 22562952 BACKGROUND

• 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.

  PMID: 21261965 BACKGROUND

• 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.

  PMID: 31255988 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Feys, Prof. dr.

  REVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 23, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

BE (2)