Task-oriented Upper Limb Training in MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688231
• Other study ID #: S58587
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Task-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.
• Control 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.

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek
Belgium	Revalidatie en MS centrum	Overpelt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

References & Publications (15)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nine Hole peg test	Manual dexterity	8 weeks
Primary	Manual Ability Measure-36	Questionnaire about perceived ADL performance	8 weeks
Primary	Isometric hand grip	Isometric hand grip	8 weeks
Primary	Training tolerance	Questionnaire of training tolerance and possible adverse effects	daily through study compeletion
Primary	pinch grip strength	pinch grip strength	8 weeks
Secondary	Motricity Index	General isometric muscle strength	8 weeks
Secondary	Muscle fatigue indices	Indices calculated based on a 30 seconds sustained maximal isometric hand grip contraction	8 weeks
Secondary	Tactile sensitivity in the fingers Semmens-Weinstein monofilaments	Tactile sensitivity in the thumb and index	8 weeks
Secondary	Rydel Seiffer Tuning fork	Vibration in the upper limb	8 weeks
Secondary	Symbol digit modalities test	Cognitive function, processing speed	8 weeks
Secondary	Box and block test	Manual dexterity	8 weeks
Secondary	Action Research Arm Test	Proximal and distal upper limb function	8 weeks
Secondary	Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)	Proximal and distal upper limb function	8 weeks
Secondary	Virtual Peg Insertion Test	manual dexterity	8 weeks
Secondary	Accelerometers (Actigraph)	actual upper limb performance in daily life	8 weeks