Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial (SlowSCA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)
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): NCT02867969
|Contact: Matthis Synofzik, PD Dr.||+firstname.lastname@example.org|
|Contact: Winfried Ilg, Dr.||+email@example.com|