VR-based Dexterity Training in MS

Christian Kamm

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Device: VR-based dexterity training in MS; Other: mediation program

Study type: Interventional

Funder types: Other

Identifiers

NCT07193602

LUKSKAMM003

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 a pathological 9-Hole-Peg-Test (9HPT) as defined by Oxford Grice et al. 2003.

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

A history of drug abuse in the 12 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental intervention = training intervention (Group1)

Experimental group

Description:

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.

Treatment:

Device: VR-based dexterity training in MS

Control inervention = Sham-Intervention (Group2)

Sham Comparator group

Description:

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.

Treatment:

Other: mediation program