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

Spinocerebellar Ataxia Clinical Trial

— Move'n Fun  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874911
• Other study ID #: Move'n Fun
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: August 17, 2016
• Start date: September 2012
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 30 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Spinocerebellar Ataxia
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait	Item 1 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8	Week 13	No
Primary	Stance	Item 2 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8	Week 13	No
Primary	Sitting	Item 3 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8	Week 13	No
Primary	Speech disturbance	Item 4 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8	Week 13	No
Primary	Finger chase	Item 5 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8	Week 13	No
Primary	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	Week 13	No
Primary	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	Week 13	No
Primary	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	Week 13	No
Secondary	Goal attainment Score	To capture translation of training effects into subjects' daily living and personally relevant activities	Week 13	No
Secondary	Quantitative movement analysis	Postural stability by quantitative movement analysis, using a motion capture system (Product name: VICON MX).	Week 13	No