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
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
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
NCT ID
NCT02874911
First Posted
August 12, 2016
Last Updated
August 17, 2016
Sponsor
University Hospital Tuebingen
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
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