Multiple Sclerosis
Conditions
Keywords
Headset-based dexterity training, Multiple Sclerosis
Brief summary
The aim of the study is to investigate if a specifically developed home-based dexterity training intervention using a Virtual Reality (VR) Headset (Meta quest 2) improves impaired manual dexterity in persons with multiple sclerosis.
Detailed description
Subjects will be recruited during regular visits at the MS centre of the Luzerner Kantonsspital, Switzerland or at the Department of Neurology of the University Hospital Basel. Ethical approval will be obtained, and the trial will be registered in the clinicaltrials.gov database. Patients must sign informed consent prior to study entry (=Screening). If patients are eligible at screening as defined in the Inclusion- and Exclusion criteria, all primary and secondary outcome measurements will be performed at Baseline. Subjects will be randomized 1:1 in Group 1 (Training intervention) or Group 2 (Sham-Intervention) and instructed into the respective training. After 4 weeks of training, all primary and secondary outcome measurements will be repeated, and the study ends.
Interventions
DEVICEVR-based dexterity training in MS
Training of limited manual dexterity in people with multiple sclerosis through a specially developed home-based dexterity training programm using a virtual headset
OTHERmediation program
Sham Training is the comparator. The Sham group is performing a commercially available mediation programm TRIPP:
Sponsors
Christian Kamm
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Raters will not be involved in the screening and randomisation process and blinded with regard to the treatment group
Intervention model description
Prospective, randomized-controlled, home-based, multi-center, rater-blinded parallel-arm pilot study. Randomisation will be performed 1:1 to the Training-Intervention group (Group 1) or Sham group (Group 2) matched for EDSS within the last 6 month using the REDCap Randomisation Tool. The EDSS-groups are: 0-2.5 3-5.5 \> 5.5
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) according to the revised McDonald's criteria (Thompson et al. 2017) * Age between 18 and 75 years * Written informed consent signed by the subject must be obtained prior to study start * Patient must complain about MS related impaired manual dexterity negatively affecting ADL and/or QoL * Patients must have Arm function in multiple sclerosis questionnaire (AMSQ) score \>41
Exclusion criteria
* A relapse that started within 60 days prior to screening * Rapidly progressive disease * Any disease/condition that impaired manual dexterity besides MS * Any disease other than MS that could possibly explain the patient's signs and symptoms * Medical or psychiatric conditions that compromise the ability to comply with the protocol, or to complete the study * History of epilepsy or epileptic seizures * A history of drug abuse in the 12 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm Function Score in Multiple Sclerosis Questionnaire | 4 weeks | The Arm Function in Multiple Sclerosis Questionnaire (AMSQ) measures manual dexterity in patients with MS. It contains 31 questions on a unidimensional scale. One final sum score is obtained with higher scores indicating more dexterous difficulties. The minimum score is 31 (no limitation) and a maximum score of 186 (extreme limitation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for completing the Nine-hole-Peg-Test (9HPT) | 4 weeks | The Nine-hole-Peg-Test (9HPT) is reliable (ICC values 0.80-0.99), valid and sensitive in detecting impaired dexterity in patients with MS. Patients were seated at a table with a shallow container holding nine pegs and a plastic block with nine empty holes. All pegs had to be put one at a time into the holes and then removed again one at a time into the shallow container. The time to complete the task was recorded twice on both hands and mean values were taken for each hand. No minimum or maximum cutoff values were defined. Higher completion times indicate poorer performance. |
| Time for completion the Coin rotation task (CRT) | 4 Weeks | The Coin rotation task (CRT) has been validated in assessing manual dexterity in patients with MS . Patients had to rotate a 50 Swiss Rappen coin (corresponding to a dime or 2-cent Euro coin) as fast as possible between their thumb, index and middle finger. The time to perform 20 half turns was measured twice on both hands and mean values were taken for each hand. No minimum or maximum cutoff values were defined. Higher completion times indicate poorer performance. |
| The highest strength value resulting from the Handheld JAMAR dynamometer | 4 Weeks | The Handheld JAMAR dynamometer is a reliable (ICC values 0.85 - 0.98) and valid test to measures isometric grip strength of the hands in healthy subjects and in MS patients. It is performed in an upright seating position with 90° flexion of the elbow next to the body. The highest value (kilograms force) of two maximum voluntary grip strength movements was taken for each hand. No minimum or maximum cutoff values were defined. Higher values indicate better performance. |
| Value resulting from the Multiple Sclerosis Impact Scale 29 (MSIS 29) | 4 Weeks | The Multiple Sclerosis Impact Scale 29 (MSIS 29) is valid and reliable in measuring the impact of MS on ADL. It contains 29 items comprising to a physical (MSIS-29 physical) and psychological impact scale (MSIS-29 psychological). All items are scored from 'not at all' to 'extremely' on a five-point Likert scale. The physical subscale ranges from 20 to 100, and the psychological from 9 to 45. Higher values indicate more impact. |
| Scores of the Electronic Neurostatus-Expanded Disability Status Scale (eEDSS) (D'Souza M et al. 2020) | 4 Weeks | Comparing the subscores of the upper extremity |
Countries
Switzerland
Contacts
CONTACTChristian Kamm, Prof. Dr. med.
Outcome results
None listed