App Based Dexterity Training in Multiple Sclerosis

NCT ID: NCT03369470

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-08-30

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

App Dexterity

Group Type: EXPERIMENTAL

App Dexterity

Intervention Type: BEHAVIORAL

App based dexterity training by means of Finger Zirkus (see for more details: www.fingers-in-motion.de)

Theraband

Group Type: ACTIVE_COMPARATOR

Theraband

Intervention Type: BEHAVIORAL

Active control being five traditional hand strengthening (Thera-band) exercises, which we published in our previous RCT, being feasible and effective in improving dexterity (for more details see for Kamm et al. 2015).

Interventions

App Dexterity

App based dexterity training by means of Finger Zirkus (see for more details: www.fingers-in-motion.de)

Intervention Type: BEHAVIORAL

Theraband

Active control being five traditional hand strengthening (Thera-band) exercises, which we published in our previous RCT, being feasible and effective in improving dexterity (for more details see for Kamm et al. 2015).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Tim Vanbellingen

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Luzerner Kantonsspital

Lucerne, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 36308305 (View on PubMed)

Other Identifiers

2017-00768

Identifier Type: -

Identifier Source: org_study_id