VR-based dexterity training in MS
DeviceTraining of limited manual dexterity in people with multiple sclerosis through a specially developed home-based dexterity training programm using a virtual headset
NCT Number: NCT07193602
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
MS Centre, Neurology, University hospital Basel, Basel, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Training of limited manual dexterity in people with multiple sclerosis through a specially developed home-based dexterity training programm using a virtual headset
Sham Training is the comparator. The Sham group is performing a commercially available mediation programm TRIPP:
Time frame: 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).
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 Weeks
Comparing the subscores of the upper extremity
Contact information is provided by the study sponsor or research team.
Christian Kamm
Other
Home-based Virtual Reality (VR) Headset-based Dexterity Training in Multiple Sclerosis: a Randomized-controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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