Multiple SclerosisNCT02688231
Task-oriented Upper Limb Training in MS
A study testing Task-oriented upper limb training in people with Multiple Sclerosis, run by Hasselt University at 2 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Task-oriented upper limb training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Hasselt University
Diepenbeek, 3560
Revalidatie en MS centrum
Overpelt, Limburg, 3900
About this study
Official title: Intensity Dependent Clinical Effects of a Task-oriented Upper Limb Training in Multiple Sclerosis
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
- Being tested
- Task-oriented upper limb training, Control intervention
- Keywords
- Multiple Sclerosis, Upper limb rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented upper limb trainingOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity group | Experimental | Not described Receives: Other: Task-oriented upper limb training |
| Low intensity group | Experimental | Not described Receives: Other: Task-oriented upper limb training |
| Control group - conventional treatment | Active comparator | Not described Receives: Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine Hole peg test
Manual dexterity
Measured: 8 weeks
Manual Ability Measure-36
Questionnaire about perceived ADL performance
Measured: 8 weeks
Isometric hand grip
Isometric hand grip
Measured: 8 weeks
Training tolerance
Questionnaire of training tolerance and possible adverse effects
Measured: daily through study compeletion
pinch grip strength
pinch grip strength
Measured: 8 weeks
Secondary outcomes (10)
Motricity Index
General isometric muscle strength
Measured: 8 weeks
Muscle fatigue indices
Indices calculated based on a 30 seconds sustained maximal isometric hand grip contraction
Measured: 8 weeks
Tactile sensitivity in the fingers Semmens-Weinstein monofilaments
Tactile sensitivity in the thumb and index
Measured: 8 weeks
Rydel Seiffer Tuning fork
Vibration in the upper limb
Measured: 8 weeks
Symbol digit modalities test
Cognitive function, processing speed
Measured: 8 weeks
Box and block test
Manual dexterity
Measured: 8 weeks
Action Research Arm Test
Proximal and distal upper limb function
Measured: 8 weeks
Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)
Proximal and distal upper limb function
Measured: 8 weeks
Virtual Peg Insertion Test
manual dexterity
Measured: 8 weeks
Accelerometers (Actigraph)
actual upper limb performance in daily life
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, Prof. dr., Principal investigator, REVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688231
- Sponsor's protocol ID
- S58587
- Status last verified
- May 2019
- First submitted
- 9 Feb 2016
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26747125Severijns 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.
PubMed 26213990Feys 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.
PubMed 26202325Alt 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.
PubMed 25880033Bertoni 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.
PubMed 25662346Severijns 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.
PubMed 25268997Lamers 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.
PubMed 25190063Lamers 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.
PubMed 24664300Lamers 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.
PubMed 24631802Lambercy 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.
PubMed 24187309Lamers 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.
PubMed 23627537Lamers 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.
PubMed 23407701van 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.
PubMed 23036010Broekmans 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.
PubMed 22562952Gijbels 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.
PubMed 21261965
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity Dependent Clinical Effects of a Task-oriented Upper Limb Training in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02688231
- Acronym / sponsor ID
- S58587
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Upper limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-oriented upper limb trainingParticipants 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. | Other | High intensity group, Low intensity group |
| Control interventionThe 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. | Other | Control group - conventional treatment |
Primary outcome
Nine Hole peg test
Time frame: 8 weeks
Manual dexterity
Manual Ability Measure-36
Time frame: 8 weeks
Questionnaire about perceived ADL performance
Isometric hand grip
Time frame: 8 weeks
Isometric hand grip
Training tolerance
Time frame: daily through study compeletion
Questionnaire of training tolerance and possible adverse effects
pinch grip strength
Time frame: 8 weeks
pinch grip strength
10 secondary outcomes
Motricity Index
Time frame: 8 weeks
Muscle fatigue indices
Time frame: 8 weeks
Tactile sensitivity in the fingers Semmens-Weinstein monofilaments
Time frame: 8 weeks
Rydel Seiffer Tuning fork
Time frame: 8 weeks
Symbol digit modalities test
Time frame: 8 weeks
Box and block test
Time frame: 8 weeks
Action Research Arm Test
Time frame: 8 weeks
Test d'Évaluation des Membres Supérieurs des Personnes Âgées (TEMPA)
Time frame: 8 weeks
Virtual Peg Insertion Test
Time frame: 8 weeks
Accelerometers (Actigraph)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Background: PubMed 26747125Lamers 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.
- Background: PubMed 26213990Severijns 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.
- Background: PubMed 26202325Feys 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.
- Background: PubMed 25880033Alt 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.
- Background: PubMed 25662346Bertoni 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.
- Background: PubMed 25268997Severijns 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.
- Background: PubMed 25190063Lamers 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.
- Background: PubMed 24664300Lamers 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.
- Background: PubMed 24631802Lamers 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.
- Background: PubMed 24187309Lambercy 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.
- Background: PubMed 23627537Lamers 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.
- Background: PubMed 23407701Lamers 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Feys, Prof. dr. principal investigator
REVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented upper limb training in people with Multiple Sclerosis, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole peg test (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688231, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.