VR-based Dexterity Training in MS

Official title

Home-based Virtual Reality (VR) Headset-based Dexterity Training in Multiple Sclerosis: a Randomized-controlled Trial

Overview

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

• Device VR-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
• Other mediation program
  Sham Training is the comparator. The Sham group is performing a commercially available mediation programm TRIPP:

Primary outcome measures

• Arm Function Score in Multiple Sclerosis Questionnaire [Time frame: 4 weeks]

Secondary outcome measures (5)

• Time for completing the Nine-hole-Peg-Test (9HPT) [Time frame: 4 weeks]
• Time for completion the Coin rotation task (CRT) [Time frame: 4 Weeks]
• The highest strength value resulting from the Handheld JAMAR dynamometer [Time frame: 4 Weeks]
• Value resulting from the Multiple Sclerosis Impact Scale 29 (MSIS 29) [Time frame: 4 Weeks]
• Scores of the Electronic Neurostatus-Expanded Disability Status Scale (eEDSS) (D'Souza M et al. 2020) [Time frame: 4 Weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Switzerland · 2 centers

• MS Centre, Neurology, University hospital Basel — Basel
• Lucerne Cantonal Hospital — Lucerne

Publications

• Yancosek KE, Howell D. A narrative review of dexterity assessments. J Hand Ther. 2009 Jul-Sep;22(3):258-69; quiz 270. doi: 10.1016/j.jht.2008.11.004. Epub 2009 Feb 12. PMID 19217254
• Winberg C, Kylberg M, Pettersson C, Harnett T, Hedvall PO, Mattsson T, Mansson Lexell E. The Use of Apps for Health in Persons with Multiple Sclerosis, Parkinson's Disease and Stroke - Barriers and Facilitators. Stud Health Technol Inform. 2017;242:638-641. PMID 28873864
• Vanbellingen T, van Beek J, Nyffeler T, Urwyler P, Nef T, Bohlhalter S. Tablet app-based dexterity-training in patients with Parkinson's disease: Pilot feasibility study. Ann Phys Rehabil Med. 2021 Jul;64(4):101419. doi: 10.1016/j.rehab.2020.06.004. Epub 2020 Oct 6. No abstract available. PMID 32755640
• van Beek JJW, van Wegen EEH, Rietberg MB, Nyffeler T, Bohlhalter S, Kamm CP, Nef T, Vanbellingen T. Feasibility of a Home-Based Tablet App for Dexterity Training in Multiple Sclerosis: Usability Study. JMIR Mhealth Uhealth. 2020 Jun 9;8(6):e18204. doi: 10.2196/18204. PMID 32515747
• van Beek JJW, van Wegen EEH, Bol CD, Rietberg MB, Kamm CP, Vanbellingen T. Tablet App Based Dexterity Training in Multiple Sclerosis (TAD-MS): Research Protocol of a Randomized Controlled Trial. Front Neurol. 2019 Feb 11;10:61. doi: 10.3389/fneur.2019.00061. eCollection 2019. PMID 30804879
• Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions PMID 29275977
• Thirumalai M, Rimmer JH, Johnson G, Wilroy J, Young HJ, Mehta T, Lai B. TEAMS (Tele-Exercise and Multiple Sclerosis), a Tailored Telerehabilitation mHealth App: Participant-Centered Development and Usability Study. JMIR Mhealth Uhealth. 2018 May 24;6(5):e10181. doi: 10.2196/10181. PMID 29798832
• Tacchino A, Pedulla L, Bonzano L, Vassallo C, Battaglia MA, Mancardi G, Bove M, Brichetto G. A New App for At-Home Cognitive Training: Description and Pilot Testing on Patients with Multiple Sclerosis. JMIR Mhealth Uhealth. 2015 Aug 31;3(3):e85. doi: 10.2196/mhealth.4269. PMID 26323749

Identifiers

NCT: NCT07193602 · LUKSKAMM003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗