Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

App Based Dexterity Training in Multiple Sclerosis (AppDext)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369470
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Tim Vanbellingen, Luzerner Kantonsspital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: App Dexterity Behavioral: Theraband Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A New App Home Based Dexterity Training in Multiple Sclerosis: a Randomized Controlled Trial
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: App Dexterity Behavioral: App Dexterity
App based dexterity training by means of Finger Zirkus (see for more details: www.fingers-in-motion.de)
Active Comparator: Theraband 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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. AMSQ, Arm Function in Multiple Sclerosis Questionnaire (AMSQ) [ Time Frame: 4 weeks ]

    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)



Secondary Outcome Measures :
  1. Nine Hole Peg Test (9HPT) [ Time Frame: 4 weeks ]

    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.


  2. Multiple Sclerosis Impact Scale 29 (MSIS 29) [ Time Frame: 4 weeks ]

    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.


  3. Coin Rotation Task (Kamm et al. 2012) [ Time Frame: 4 weeks ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369470


Contacts
Layout table for location contacts
Contact: Tim Vanbellingen, PhD 0041 41 205 56 34 tim.vanbellingen@luks.ch
Contact: Christian Kamm, MD 0041 41 205 51 08 christian.kamm@luks.ch

Locations
Layout table for location information
Switzerland
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, 6000
Contact: Tim Vanbellingen, PhD    0041 41 205 56 34    tim.vanbellingen@dkf.unibe.ch   
Contact: Stephan Bohlhalter, MD    0041 41 205 51 17    stephan.bohlhalter@luks.ch   
Sponsors and Collaborators
Luzerner Kantonsspital
University Hospital Inselspital, Berne
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tim Vanbellingen, Head of department, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT03369470    
Other Study ID Numbers: 2017-00768
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases