NCT02874911

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 12, 2016

Last Update Submit

August 17, 2016

Conditions

Spinocerebellar Ataxia

Keywords

ExergamingNeurodegenerative diseasesRare diseaseMotor exercisesTrainingSpinocerebellar ataxia

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (2)

  • Goal attainment Score

    Week 13

  • Quantitative movement analysis

    Week 13

Study Arms (1)

General training

EXPERIMENTAL

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

Other: General training

Interventions

General trainingOTHER

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

General training

Eligibility Criteria

Age5 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28365204DERIVED

MeSH Terms

Conditions

Spinocerebellar AtaxiasNeurodegenerative DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Cerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinocerebellar DegenerationsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemAtaxiaDyskinesiasNeurologic ManifestationsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Synofzik Matthis, PD Dr.

    University Hospital Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 22, 2016

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

March 1, 2016

Last Updated

August 22, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share