NCT02867969

Brief Summary

This is a piloting study using continuous motor training provided via whole body-controlled video games (exergames) to establish proof-of-concept evidence that such training leads to motor and neural changes in pre-manifest subjects with spinocerebellar ataxias (SCA).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

August 11, 2016

Last Update Submit

August 11, 2016

Conditions

Spinocerebellar Ataxia

Keywords

Spinocerebellar ataxiaExergamingNeurodegenerative diseasesRare diseaseMotor exercisesPremanifest stageTraining

Outcome Measures

Primary Outcomes (1)

  • Gait score

    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

    Day 43

Secondary Outcomes (5)

  • Brain networks captured

    Day 43

  • Quantitative movement parameters

    Day 43

  • Ataxia severity

    Day 43

  • Daily activity

    Day 43

  • Brain-derived neurotrophic factor

    Day 43

Study Arms (1)

Motor training

OTHER

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

Interventions

Motor trainingOTHER

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.

Also known as: Exergaming
Motor training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult persons (age 18-80 years) who (i) are a blood-related relative of an index subject with a known SCA 1,2,3 or 6 mutation and who (ii) have a score value of \<8 points on the Scale for the Assessment and Rating of Ataxia (SARA)
  • full capacity to consent to study participation after extensive information (fully Informed Consent)

You may not qualify if:

  • Cognitive deficits which prevent full comprehension of the study requirements and/or training requirements
  • Comorbid diseases that place severe constraints on a continous training with whole-body controlled exergames (e.g. severe visual or hearing deficits; severe paresis; severe movement disorders other than ataxia)
  • Comorbid neurologic disease other than ataxia (e.g. prior stroke or brain trauma)
  • Pregnant or breast-feeding persons
  • Lack of capacity for full informed consent according to established psychiatric criteria for full informed consent
  • cardiac pacemakers
  • artificial heart valves
  • metal prostheses
  • implanted magnetic metal parts (screws, plates and similar devices)
  • intrauterine devices (for instance, for contraceptive purposes)
  • shrapnel parts and other metal pieces
  • non-removable braces and metal dentures
  • non-removable acupuncture needles
  • insulin pumps and infusion ports
  • tattoos, eye shadow and other metal-containing make-up
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Spinocerebellar AtaxiasNeurodegenerative DiseasesRare Diseases

Interventions

Exergaming

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

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Matthis Synofzik, PD Dr.

CONTACT

+49-7071-2982060matthis.synofzik@uni-tuebingen.de

Winfried Ilg, Dr.

CONTACT

+49-7071-2989125winfried.ilg@uni-tuebingen.de

Study Design

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

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

August 16, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)