NCT02900508

Brief Summary

The purpose of this study was to investigate the effects of virtual reality-base training for cerebellar ataxia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

September 6, 2016

Last Update Submit

September 8, 2016

Conditions

Cerebellar Ataxia

Outcome Measures

Primary Outcomes (3)

  • Scale for the Assessment and Rating of Ataxia

    Change from baseline at 4 weeks

  • Alternate nose to finger test

    Change from baseline at 4 weeks

  • Alternate heel on shin test

    Change from baseline at 4 weeks

Secondary Outcomes (3)

  • Nine-hole peg test

    Change from baseline at 4 weeks

  • Walking speed

    Change from baseline at 4 weeks

  • Step width

    Change from baseline at 4 weeks

Study Arms (2)

Exergaming training

EXPERIMENTAL

Participants in the exergaming training group received a 4-week exergaming intervention.

Other: Exergaming training

Control training

ACTIVE COMPARATOR

Participants in the control training group received a 4-week conventional training.

Other: Physical therapy intervention

Interventions

Exergaming trainingOTHER
Exergaming training
Physical therapy interventionOTHER
Control training

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of SCA 1, 2, 3 and 6 by a neurologist
  • ability to walk independently with or without any walking aids
  • age ≥ 20
  • a score of ≥ 24 on the mini-mental state examination

You may not qualify if:

  • histories of other neurological, cardiovascular, or orthopedic diseases affecting motor performance and balance
  • uncontrolled chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebellar Ataxia

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 14, 2016

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

September 14, 2016

Record last verified: 2016-09