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Multiple SclerosisAppDextNCT03369470

App Based Dexterity Training in Multiple Sclerosis

A study testing App Dexterity and Theraband in people with Multiple Sclerosis, run by Luzerner Kantonsspital at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
App Dexterity and Theraband
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
1 Dec 2017to 30 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Luzerner Kantonsspital

    Lucerne, 6000

Other trials in Switzerland

About this study

Official title: A New App Home Based Dexterity Training in Multiple Sclerosis: a Randomized Controlled Trial

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).

Being tested
App Dexterity, Theraband
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App DexterityBehavioural

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

  • TherabandBehavioural

    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).

Study groups in NCT03369470
Study groupRoleWhat they receive
App DexterityExperimentalNot described
Receives: Behavioral: App Dexterity
TherabandActive comparatorNot described
Receives: Behavioral: Theraband

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 4 weeks

Secondary outcomes (3)

  1. Nine Hole Peg Test (9HPT)

    9HPT is a reliable, valid and sensitive in detecting impaired dexterity in patients with MS (Lamers et al. 2014).

    The Nine Hole Peg Test (9HPT) is reliable (ICC values 0.80-0.99), valid and sensitive in detecting impaired dexterity in patients with MS. Patients were seated at a table with a shallow container holding nine pegs and a plastic block with nine empty holes. All pegs had to be put one at a time into the holes and then removed again one at a time into the shallow container. The time to complete the task was recorded twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was chosen.

    Measured: 4 weeks

  2. Multiple Sclerosis Impact Scale 29 (MSIS 29)

    is a health-rated quality of life questionnaire (HRQoL) assessing the impact of MS on physical and psychological functions (Hobart et al. 2001).

    The Multiple Sclerosis Impact Scale (MSIS-29) is valid and reliable (ICC 0.80 - 0.87) in measuring the impact of MS on ADL.It contains 29 items comprising to a physical (MSIS-29 physical) and psychological impact scale (MSIS-29 psychological). All items are scored from 'not at all' to 'extremely' on a five-point Likert scale.

    Measured: 4 weeks

  3. Coin Rotation Task (Kamm et al. 2012)

    is a measure for dexterity. The Coin Rotation Task (CRT) has been validated in assessing manual dexterity in patients with MS. Patients had to rotate a 50 Swiss Rappen coin (corresponding to a dime or 2-cent Euro coin) as fast as possible between their thumb, index and middle finger. The time to perform 20 half turns was measured twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was taken.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2017
  2. Study start1 Dec 2017
  3. Primary completion1 Aug 2021
  4. Study completion30 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03369470
Sponsor's protocol ID
2017-00768
Other IDs
2017
Acronym
AppDext
Status last verified
Aug 2021
First submitted
6 Dec 2017
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36308305

Questions about this trial

What is this clinical trial studying?

A study testing App Dexterity and Theraband in people with Multiple Sclerosis, run by Luzerner Kantonsspital at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AMSQ, Arm Function in Multiple Sclerosis Questionnaire (AMSQ) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03369470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.

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