Clinical trial NCT02874911: Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias
Official title: Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinocerebellar Ataxia
Keywords: Exergaming
Neurodegenerative diseases
Rare disease
Motor exercises
Training
Spinocerebellar ataxia
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Gait
timeFrame: Week 13
measure: Stance
timeFrame: Week 13
measure: Sitting
timeFrame: Week 13
measure: Speech disturbance
timeFrame: Week 13
measure: Finger chase
timeFrame: Week 13
measure: Nose-finger Test
timeFrame: Week 13
measure: Fast alternating hand movements
timeFrame: Week 13
measure: Heel-shin slide
timeFrame: Week 13
Secondary outcomes:
measure: Goal attainment Score
timeFrame: Week 13
measure: Quantitative movement analysis
timeFrame: Week 13
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Tübingen
name: Synofzik Matthis, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.