Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial (SlowSCA)
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|ClinicalTrials.gov Identifier: NCT02867969|
Recruitment Status : Unknown
Verified August 2016 by University Hospital Tuebingen.
Recruitment status was: Recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Spinocerebellar Ataxia||Other: Motor training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||May 2017|
The motor training comprise of demanding coordinative exercises based on commercially available developed by Microsoft Game Console (XBOX Kinect™) exergames that specifically target ataxia dysfunctions.
Other: Motor training
The motor training will comprise of demanding coordinative exercises based on commercially available developed by Microsoft Game Console (XBOX Kinect™) exergames that specifically target ataxia dysfunctions.
Other Name: Exergaming
- Gait score [ Time Frame: Day 43 ]Decrease in a quantitative composite gait score consisting of body sway and gait variability in walking challenge conditions (mattress), assessed by VICON-based motion tracking
- Brain networks captured [ Time Frame: Day 43 ]Changes in brain networks captured by specific neuroimaging focussing on brain grey matter volume (VBM), brain fibre tracking (DTI) and functional connectivity of the cerebellum with other brain regions (resting-state connectivity)
- Quantitative movement parameters [ Time Frame: Day 43 ]Set of quantitative movement parameters for complex whole-body movements (gait, stand, fast sequences of goal-directed stepping movements) (VICON-based motion tracking).
- Ataxia severity [ Time Frame: Day 43 ]Clinical ataxia severity according to the Scale for the Assessment and Rating of Ataxia (SARA)
- Daily activity [ Time Frame: Day 43 ]Objectively measured level of daily activity in subjects' real-world settings (body-worn motions sensors; ActivePal®)
- Brain-derived neurotrophic factor [ Time Frame: Day 43 ]Increase of serum brain-derived neurotrophic factor (BDNF)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867969
|Contact: Matthis Synofzik, PD Dr.||+firstname.lastname@example.org|
|Contact: Winfried Ilg, Dr.||+email@example.com|