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Trial record 31 of 122 for:    "spinocerebellar ataxia type 2" OR "Spinocerebellar Ataxias"

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

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ClinicalTrials.gov Identifier: NCT02874911
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Exergame training might offer a novel treatment approach even in largely nonambulatory subjects with multisystemic degenerative spinocerebellar ataxia.

Condition or disease Intervention/treatment Phase
Spinocerebellar Ataxia Other: General training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Experimental: General training
Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).
Other: General training
Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).




Primary Outcome Measures :
  1. Gait [ Time Frame: Week 13 ]
    Item 1 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

  2. Stance [ Time Frame: Week 13 ]
    Item 2 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

  3. Sitting [ Time Frame: Week 13 ]
    Item 3 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

  4. Speech disturbance [ Time Frame: Week 13 ]
    Item 4 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

  5. Finger chase [ Time Frame: Week 13 ]
    Item 5 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

  6. Nose-finger Test [ Time Frame: Week 13 ]
    Item 6 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

  7. Fast alternating hand movements [ Time Frame: Week 13 ]
    Item 7 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

  8. Heel-shin slide [ Time Frame: Week 13 ]
    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 :
  1. Goal attainment Score [ Time Frame: Week 13 ]
    To capture translation of training effects into subjects' daily living and personally relevant activities

  2. Quantitative movement analysis [ Time Frame: Week 13 ]
    Postural stability by quantitative movement analysis, using a motion capture system (Product name: VICON MX).



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Ages Eligible for Study:   5 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02874911


Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Synofzik Matthis, PD Dr. University Hospital Tübingen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02874911     History of Changes
Other Study ID Numbers: Move'n Fun
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital Tuebingen:
Exergaming
Neurodegenerative diseases
Rare disease
Motor exercises
Training
Spinocerebellar ataxia

Additional relevant MeSH terms:
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Ataxia
Cerebellar Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn