NCT03369470

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

3.7 years

First QC Date

December 6, 2017

Last Update Submit

August 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • AMSQ, Arm Function in Multiple Sclerosis Questionnaire (AMSQ)

    AMSQ is a patient recorded outcome measurement for manual dexterity in MS patients (Mokkink et al. 2015). The "Arm Function in Multiple Sclerosis Questionnaire" (AMSQ) measures manual dexterity in patients with MS. It contains 31 questions on a unidimensional scale that are formulated as 'during the past two weeks, to what extent has MS limited your ability to ......?'. Response categories are from one to six ('not at all', 'a little', 'moderately', 'quite a lot', 'extremely', and 'no longer able to'). One final sum score is obtained with higher scores indicating more dexterous difficulties.The Dutch version showed good validity, test-retest reliability (ICC 0.90; SEM 5.6) and inter-observer reliability (ICC 0.95; SEM 7.2)

    4 weeks

Secondary Outcomes (3)

  • Nine Hole Peg Test (9HPT)

    4 weeks

  • Multiple Sclerosis Impact Scale 29 (MSIS 29)

    4 weeks

  • Coin Rotation Task (Kamm et al. 2012)

    4 weeks

Study Arms (2)

App Dexterity

EXPERIMENTAL
Behavioral: App Dexterity

Theraband

ACTIVE COMPARATOR
Behavioral: Theraband

Interventions

App DexterityBEHAVIORAL

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

App Dexterity
TherabandBEHAVIORAL

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).

Theraband

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 12, 2017

Study Start

December 1, 2017

Primary Completion

August 1, 2021

Study Completion

August 30, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations