search
Back to results

Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias (Move'n Fun)

Primary Purpose

Spinocerebellar Ataxia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
General training
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinocerebellar Ataxia focused on measuring Exergaming, Neurodegenerative diseases, Rare disease, Motor exercises, Training, Spinocerebellar ataxia

Eligibility Criteria

5 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced spinocerebellar disease
  • Advanced impairments in gait and stance, defined as Scale for Assessment and Rating of Ataxia (SARA) subscore gait ≥3 and stance ≥3, but still able to sit without support >10 seconds, as defined by SARA subscore sitting <3
  • Age between 5 and 30 years

Exclusion Criteria:

  • Any signs of inflammatory, vascular, malformation, or tumor cerebrospinal (CNS) disease
  • Visual loss, hearing disturbances, mental retardation and predominant non-ataxia movement disorders (e.g. predominant spasticity, chorea, parkinsonism)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    General training

    Arm Description

    Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).

    Outcomes

    Primary Outcome Measures

    Gait
    Item 1 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Stance
    Item 2 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Sitting
    Item 3 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Speech disturbance
    Item 4 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Finger chase
    Item 5 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Nose-finger Test
    Item 6 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Fast alternating hand movements
    Item 7 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Heel-shin slide
    Item 8 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

    Secondary Outcome Measures

    Goal attainment Score
    To capture translation of training effects into subjects' daily living and personally relevant activities
    Quantitative movement analysis
    Postural stability by quantitative movement analysis, using a motion capture system (Product name: VICON MX).

    Full Information

    First Posted
    August 12, 2016
    Last Updated
    August 17, 2016
    Sponsor
    University Hospital Tuebingen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02874911
    Brief Title
    Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias
    Acronym
    Move'n Fun
    Official Title
    Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital Tuebingen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Exergame training might offer a novel treatment approach even in largely nonambulatory subjects with multisystemic degenerative spinocerebellar ataxia.
    Detailed Description
    Effective treatments for patients with degenerative spinocerebellar ataxia are scarce. It has recently been shown that intensive coordinative training based on either physiotherapy or exergames (= whole-body controlled videogames; might improve degenerative ataxia, but its effectiveness is still disputed. This situation is even more complicated for degenerative ataxia subjects in advanced disease stages and with high multisystemic disease load. Here, underlying neurodegeneration has progressed to many irreversible states and includes many additional extra-cerebellar systems, making functional plasticity and therapeutic success much less likely. Moreover, intervention outcome assessment in subjects unable to walk freely is more delicate. Correspondingly, nonambulatory ataxia subjects in advanced disease stages are currently often excluded from treatment trials, thus leaving them without prospects of access to novel treatments. The investigators here hypothesized that exergame training might offer a novel treatment approach even in largely nonambulatory subjects with multisystemic degenerative spinocerebellar ataxia. Using a rater-blinded, intraindividual control study design, the investigators show that an individualized exergame training strategy, tailored to individuals' disease stage, improves postural control and ataxia-specific control functions even in advanced disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinocerebellar Ataxia
    Keywords
    Exergaming, Neurodegenerative diseases, Rare disease, Motor exercises, Training, Spinocerebellar ataxia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    General training
    Arm Type
    Experimental
    Arm Description
    Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).
    Intervention Type
    Other
    Intervention Name(s)
    General training
    Intervention Description
    Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).
    Primary Outcome Measure Information:
    Title
    Gait
    Description
    Item 1 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Title
    Stance
    Description
    Item 2 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Title
    Sitting
    Description
    Item 3 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Title
    Speech disturbance
    Description
    Item 4 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Title
    Finger chase
    Description
    Item 5 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Title
    Nose-finger Test
    Description
    Item 6 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Title
    Fast alternating hand movements
    Description
    Item 7 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Title
    Heel-shin slide
    Description
    Item 8 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8
    Time Frame
    Week 13
    Secondary Outcome Measure Information:
    Title
    Goal attainment Score
    Description
    To capture translation of training effects into subjects' daily living and personally relevant activities
    Time Frame
    Week 13
    Title
    Quantitative movement analysis
    Description
    Postural stability by quantitative movement analysis, using a motion capture system (Product name: VICON MX).
    Time Frame
    Week 13

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Advanced spinocerebellar disease Advanced impairments in gait and stance, defined as Scale for Assessment and Rating of Ataxia (SARA) subscore gait ≥3 and stance ≥3, but still able to sit without support >10 seconds, as defined by SARA subscore sitting <3 Age between 5 and 30 years Exclusion Criteria: Any signs of inflammatory, vascular, malformation, or tumor cerebrospinal (CNS) disease Visual loss, hearing disturbances, mental retardation and predominant non-ataxia movement disorders (e.g. predominant spasticity, chorea, parkinsonism)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Synofzik Matthis, PD Dr.
    Organizational Affiliation
    University Hospital Tübingen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28365204
    Citation
    Schatton C, Synofzik M, Fleszar Z, Giese MA, Schols L, Ilg W. Individualized exergame training improves postural control in advanced degenerative spinocerebellar ataxia: A rater-blinded, intra-individually controlled trial. Parkinsonism Relat Disord. 2017 Jun;39:80-84. doi: 10.1016/j.parkreldis.2017.03.016. Epub 2017 Mar 28.
    Results Reference
    derived

    Learn more about this trial

    Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias

    We'll reach out to this number within 24 hrs