NCT07193602

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
23mo left

Started May 2026

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026May 2028

First Submitted

Initial submission to the registry

September 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

September 18, 2025

Last Update Submit

April 8, 2026

Conditions

Keywords

Headset-based dexterity trainingMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Arm Function Score in Multiple Sclerosis Questionnaire

    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).

    4 weeks

Secondary Outcomes (5)

  • Time for completing the Nine-hole-Peg-Test (9HPT)

    4 weeks

  • Time for completion the Coin rotation task (CRT)

    4 Weeks

  • The highest strength value resulting from the Handheld JAMAR dynamometer

    4 Weeks

  • Value resulting from the Multiple Sclerosis Impact Scale 29 (MSIS 29)

    4 Weeks

  • Scores of the Electronic Neurostatus-Expanded Disability Status Scale (eEDSS) (D'Souza M et al. 2020)

    4 Weeks

Study Arms (2)

Experimental intervention = training intervention (Group1)

EXPERIMENTAL

Eight training programs will be performed addressing different key movements of the hand/arm. All training programs will be performed in sitting position. Training will be performed for 4 weeks, 5 days/week. All 8 training programs will be performed on every training day which corresponds to approximately 20min training/day.

Device: VR-based dexterity training in MS

Control inervention = Sham-Intervention (Group2)

SHAM COMPARATOR

The Sham-Intervention will be the commercially available meditations App "Tripp®". During a period of four weeks, patients will perform the Sham intervention 3 times a week, each session being approximately 20 minutes.

Other: mediation program

Interventions

Training of limited manual dexterity in people with multiple sclerosis through a specially developed home-based dexterity training programm using a virtual headset

Experimental intervention = training intervention (Group1)

Sham Training is the comparator. The Sham group is performing a commercially available mediation programm TRIPP:

Control inervention = Sham-Intervention (Group2)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MS Centre, Neurology, University hospital Basel

Basel, Basel, 4031, Switzerland

Location

Lucerne Cantonal Hospital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (30)

  • 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: 19217254BACKGROUND
  • 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: 28873864BACKGROUND
  • 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: 32755640BACKGROUND
  • 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: 32515747BACKGROUND
  • 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: 30804879BACKGROUND
  • 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 of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.

    PMID: 29275977BACKGROUND
  • 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: 29798832BACKGROUND
  • 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: 26323749BACKGROUND
  • Steinheimer S, Wendel M, Vanbellingen T, Westers LT, Hodak J, Blatter V, Uitdehaag BMJ, Kamm CP. The Arm Function in Multiple Sclerosis Questionnaire was successfully translated to German. J Hand Ther. 2018 Jan-Mar;31(1):137-140.e1. doi: 10.1016/j.jht.2017.09.010. No abstract available.

    PMID: 29102479BACKGROUND
  • Riazi A, Hobart JC, Lamping DL, Fitzpatrick R, Thompson AJ. Multiple Sclerosis Impact Scale (MSIS-29): reliability and validity in hospital based samples. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):701-4. doi: 10.1136/jnnp.73.6.701.

    PMID: 12438473BACKGROUND
  • Peolsson A, Hedlund R, Oberg B. Intra- and inter-tester reliability and reference values for hand strength. J Rehabil Med. 2001 Jan;33(1):36-41. doi: 10.1080/165019701300006524.

    PMID: 11480468BACKGROUND
  • Paltamaa J, West H, Sarasoja T, Wikstrom J, Malkia E. Reliability of physical functioning measures in ambulatory subjects with MS. Physiother Res Int. 2005;10(2):93-109. doi: 10.1002/pri.30.

    PMID: 16146327BACKGROUND
  • Oxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.

    PMID: 14527120BACKGROUND
  • McGuigan C, Hutchinson M. The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):266-9.

    PMID: 14742602BACKGROUND
  • Marrie RA, Leung S, Tyry T, Cutter GR, Fox R, Salter A. Use of eHealth and mHealth technology by persons with multiple sclerosis. Mult Scler Relat Disord. 2019 Jan;27:13-19. doi: 10.1016/j.msard.2018.09.036. Epub 2018 Oct 2.

    PMID: 30296732BACKGROUND
  • Mokkink LB, Knol DL, van der Linden FH, Sonder JM, D'hooghe M, Uitdehaag BMJ. The Arm Function in Multiple Sclerosis Questionnaire (AMSQ): development and validation of a new tool using IRT methods. Disabil Rehabil. 2015 Dec;37(26):2445-2451. doi: 10.3109/09638288.2015.1027005. Epub 2015 Mar 24.

    PMID: 25801923BACKGROUND
  • Lamers 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.

    PMID: 24631802BACKGROUND
  • Kamm CP, Uitdehaag BM, Polman CH. Multiple sclerosis: current knowledge and future outlook. Eur Neurol. 2014;72(3-4):132-41. doi: 10.1159/000360528. Epub 2014 Jul 30.

    PMID: 25095894BACKGROUND
  • Kamm CP, Mattle HP, Muri RM, Heldner MR, Blatter V, Bartlome S, Luthy J, Imboden D, Pedrazzini G, Bohlhalter S, Hilfiker R, Vanbellingen T. Home-based training to improve manual dexterity in patients with multiple sclerosis: A randomized controlled trial. Mult Scler. 2015 Oct;21(12):1546-56. doi: 10.1177/1352458514565959. Epub 2015 Jan 26.

    PMID: 25623246BACKGROUND
  • Kamm CP, Blattler R, Kueng R, Vanbellingen T. Feasibility and usability of a new home-based immersive virtual reality headset-based dexterity training in multiple sclerosis. Mult Scler Relat Disord. 2023 Mar;71:104525. doi: 10.1016/j.msard.2023.104525. Epub 2023 Jan 20.

    PMID: 36738693BACKGROUND
  • Kamm CP, Kueng R, Blattler R. Development of a new immersive virtual reality (VR) headset-based dexterity training for patients with multiple sclerosis: Clinical and technical aspects. Technol Health Care. 2024;32(2):1067-1078. doi: 10.3233/THC-230541.

    PMID: 37545286BACKGROUND
  • Kalkers NF, Galan I, Kerbrat A, Tacchino A, Kamm CP, O'Connell K, McGuigan C, Edan G, Montalban X, Uitdehaag BM, Mokkink LB. Differential item functioning of the Arm function in Multiple Sclerosis Questionnaire (AMSQ) by language, a study in six countries. Mult Scler. 2021 Jan;27(1):90-96. doi: 10.1177/1352458519895450. Epub 2019 Dec 17.

    PMID: 31845614BACKGROUND
  • Jonsdottir J, Perini G, Ascolese A, Bowman T, Montesano A, Lawo M, Bertoni R. Unilateral arm rehabilitation for persons with multiple sclerosis using serious games in a virtual reality approach: Bilateral treatment effect? Mult Scler Relat Disord. 2019 Oct;35:76-82. doi: 10.1016/j.msard.2019.07.010. Epub 2019 Jul 20.

    PMID: 31352180BACKGROUND
  • Johansson S, Ytterberg C, Claesson IM, Lindberg J, Hillert J, Andersson M, Widen Holmqvist L, von Koch L. High concurrent presence of disability in multiple sclerosis. Associations with perceived health. J Neurol. 2007 Jun;254(6):767-73. doi: 10.1007/s00415-006-0431-5. Epub 2007 Apr 2.

    PMID: 17401746BACKGROUND
  • Hollywood RA, Poyade M, Paul L, Webster A. Proof of Concept for the Use of Immersive Virtual Reality in Upper Limb Rehabilitation of Multiple Sclerosis Patients. Adv Exp Med Biol. 2022;1356:73-93. doi: 10.1007/978-3-030-87779-8_4.

    PMID: 35146618BACKGROUND
  • Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain. 2001 May;124(Pt 5):962-73. doi: 10.1093/brain/124.5.962.

    PMID: 11335698BACKGROUND
  • Heldner MR, Vanbellingen T, Bohlhalter S, Mattle HP, Muri RM, Kamm CP. Coin rotation task: a valid test for manual dexterity in multiple sclerosis. Phys Ther. 2014 Nov;94(11):1644-51. doi: 10.2522/ptj.20130252. Epub 2014 Jun 19.

    PMID: 24947199BACKGROUND
  • Goodkin DE, Hertsgaard D, Seminary J. Upper extremity function in multiple sclerosis: improving assessment sensitivity with box-and-block and nine-hole peg tests. Arch Phys Med Rehabil. 1988 Oct;69(10):850-4.

    PMID: 3178453BACKGROUND
  • D'Souza M, Heikkila A, Lorscheider J, Haller V, Kravalis K, Gysin S, Fuertes NAC, Fricker E, Lam E, Higgins P, Tomic D, Papadopoulou A, Kappos L. Electronic Neurostatus-EDSS increases the quality of expanded disability status scale assessments: Experience from two phase 3 clinical trials. Mult Scler. 2020 Jul;26(8):993-996. doi: 10.1177/1352458519845108. Epub 2019 May 7.

    PMID: 31060429BACKGROUND
  • Bertoni R, Mestanza Mattos FG, Porta M, Arippa F, Cocco E, Pau M, Cattaneo D. Effects of immersive virtual reality on upper limb function in subjects with multiple sclerosis: A cross-over study. Mult Scler Relat Disord. 2022 Sep;65:104004. doi: 10.1016/j.msard.2022.104004. Epub 2022 Jun 30.

    PMID: 35797804BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Christian Kamm, Prof. Dr. med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Raters will not be involved in the screening and randomisation process and blinded with regard to the treatment group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

September 18, 2025

First Posted

September 26, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations