Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02493166
Other study ID # 2015-PFE-JRA01
Secondary ID
Status Completed
Phase N/A
First received July 2, 2015
Last updated June 13, 2016
Start date March 2016
Est. completion date June 2016

Study information

Verified date June 2016
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central nervous system, with more than 2.5 million people in the world. It is the most non-traumatic cause of disability in young and middle-aged adults.

Because the lesions are spread in the brains, there is a variety of symptoms. The most common symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of them after 15 years, have problems with movements in one or both upper extremities.

Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although they are less visible, they can have a major determining influence on social or work-related domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of information processing, impaired memory and limited executive functions.

When a combination, of motor and cognitive task, is asked, the execution of these tasks could be difficult with the foregoing in mind. For example problems during chatting while cooking, typing a report at a meeting or watching television while ironing.

The dual-task paradigm assumes that the attention should be divided between two simultaneous tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit the separate task versus simultaneously.

Research on dual tasking with persons with MS has already studied extensively, but not specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary research on the DTC. They combined the movements of the upper limb with a cognitive task. The research showed a difference between Persons with MS and the control group. At methodological level, there is lacking on the randomization of tasks. That is an important bias because of the learning effect of the tasks. They used only one task for the upper limb; this isn't enough to generalize the concept of motor interference in Persons with MS.

The study has two research questions:

- Have Persons with MS a greater DTC compared with a healthy control group? The motor task is executed with the upper limb.

- Is there a difference on DTC in persons with MS depending on the motor task?

This research is an observational case-control study in which individuals with MS will be compared to a healthy control group. They will be two moments of assessments. On the first day the general performance of the persons will be measured, by using clinical evaluation tests and questionnaires. On the second day they will be tests on the dual tasks, specific a comparison between single versus simultaneously performed tasks.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of MS according to McDonald's criteria

- 18+

- Have no other neurological or orthopedic disorder of the upper limb or spine. They should have the possibility to actively participate in the research.

- Nine hole peg test, in which the cut-off value is set at 0.5 PEG / sec

Exclusion Criteria:

- Patients are excluded with serious psychological problems.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
dual task cost (cognitive-motor interference)
comparing single versus dual task performance (on both motor and cognitive task)

Locations

Country Name City State
Belgium AZ Klina Brasschaat
Belgium Private practice physician De Barsy Brasschaat
Belgium Hasselt University Diepenbeek
Belgium UZ Antwerp Edegem

Sponsors (4)

Lead Sponsor Collaborator
Hasselt University AZ Klina, private practice physician De Barsy, UZA

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary single motor task cost comparing single versus dual task performance on motor task day 1 No
Primary Dual motor task cost Comparing single versus dual task performance on congnitive task day 2 No
Primary single cognitive task cost Comparing single versus dual task performance on congnitive task day 1 No
Primary Dual cognitive task cost Comparing single versus dual task performance on congnitive task day 2 No
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4