Clinical trial NCT03369470: App Based Dexterity Training in Multiple Sclerosis
Official title: A New App Home Based Dexterity Training in Multiple Sclerosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2017-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the most common cause of non-traumatic disability in young adults (Kamm et al. 2014; Vanbellingen \& Kamm, 2016). It is a heterogeneous disease, which is associated with long-term disability, leading to reduced quality of life (QoL). Disease-modifying pharmacological therapies (DMT) decrease activity and progression of the disease, and symptomatic pharmacological treatments reduce complaints to a certain extent, however MS patients often still suffer from various neurological deficits during the course of their disease (Kamm et al. 2014). Consequently, specific non-pharmacological therapies are needed in order to further reduce disability, eventually resulting in better QoL (Lamers et al. 2016; Vanbellingen \& Kamm, 2016).

Impaired dexterity is a frequently observed impairment, affecting up to 76% of patients with MS (Johannson et al. 2007). The different neurological deficits caused by MS, such as ataxia, spasticity, sensory-motor deficits, and apraxia may be alone or in combination, impair manual dexterity (Kamm et al. 2012; Heldner, Vanbellingen et al. 2014). MS patients experience impairments in the performance of several activities of daily living (ADL), such as grooming, cooking, etc. Sometimes these problems are even associated with loss of work, and lack of social integration (Chruzander et al. 2013).

The effectiveness of the app based exercises still needs to be proven. With respect to dexterity, a first new app has been developed called "Finger Zirkus", by a team of experts including an occupational therapist, graphic designer, and IT expert. The app is already available to be downloaded from google play store or apple store (see for more details: www.fingers-in-motion.de).


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for MS patients are as follows: males and females, age 18 to 75, diagnosis of MS (primary or secondary progressive, relapsing-remitting) following the McDonald criteria (Polman et al. 2011). In addition, patients must report difficulties in manual dexterity that impact ADL and/or have a pathological nine Hole Peg Test (9HPT) or Coin Rotation test (CRT) according to cut-off values (Mathiowetz et al. 1985; Heldner, Vanbellingen et al. 2014).

Exclusion Criteria:

* The exclusion criteria will be other conditions that may hand function or, impaired cognitive functioning (Mini Mental Status Examination score less than 24).

Primary outcomes:
measure: AMSQ, Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
timeFrame: 4 weeks
Secondary outcomes:
measure: Nine Hole Peg Test (9HPT)
timeFrame: 4 weeks
measure: Multiple Sclerosis Impact Scale 29 (MSIS 29)
timeFrame: 4 weeks
measure: Coin Rotation Task (Kamm et al. 2012)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
References:
citation: van Beek JJW, Lehnick D, Pastore-Wapp M, Wapp S, Kamm CP, Nef T, Vanbellingen T. Tablet app-based dexterity training in multiple sclerosis (TAD-MS): a randomized controlled trial. Disabil Rehabil Assist Technol. 2024 Apr;19(3):889-899. doi: 10.1080/17483107.2022.2131915. Epub 2022 Oct 29.