Cerebellar AtaxiaNCT02900508
Virtual Reality-based Training in Cerebellar Ataxia
A study testing Exergaming training and Physical therapy intervention in people with Cerebellar Ataxia, run by National Yang Ming Chiao Tung University.
Trial summary
The purpose of this study was to investigate the effects of virtual reality-base training for cerebellar ataxia. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- Exergaming training and Physical therapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- histories of other neurological, cardiovascular, or orthopedic diseases affecting motor performance and balance
- uncontrolled chronic diseases
About this study
The purpose of this study was to investigate the effects of virtual reality-base training for cerebellar ataxia.
- Conditions
- Cerebellar Ataxia
- Being tested
- Exergaming training, Physical therapy intervention
- Medical subject headings
- Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming trainingOther
Physical therapy interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Exergaming training | Experimental | Participants in the exergaming training group received a 4-week exergaming intervention. Receives: Other: Exergaming training |
| Control training | Active comparator | Participants in the control training group received a 4-week conventional training. Receives: Other: Physical therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment and Rating of Ataxia
Measured: Change from baseline at 4 weeks
Alternate nose to finger test
Measured: Change from baseline at 4 weeks
Alternate heel on shin test
Measured: Change from baseline at 4 weeks
Secondary outcomes (3)
Nine-hole peg test
Measured: Change from baseline at 4 weeks
Walking speed
Measured: Change from baseline at 4 weeks
Step width
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900508
- Sponsor's protocol ID
- 201410010A
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-based Training in Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT02900508
- Acronym / sponsor ID
- 201410010A
- Conditions
- Cerebellar Ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the effects of virtual reality-base training for cerebellar ataxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming training | Experimental | Other: Exergaming trainingParticipants in the exergaming training group received a 4-week exergaming intervention. |
| Control training | Active comparator | Other: Physical therapy interventionParticipants in the control training group received a 4-week conventional training. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- histories of other neurological, cardiovascular, or orthopedic diseases affecting motor performance and balance
- uncontrolled chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergaming training | Other | Exergaming training |
| Physical therapy intervention | Other | Control training |
Primary outcome
Scale for the Assessment and Rating of Ataxia
Time frame: Change from baseline at 4 weeks
Alternate nose to finger test
Time frame: Change from baseline at 4 weeks
Alternate heel on shin test
Time frame: Change from baseline at 4 weeks
3 secondary outcomes
Nine-hole peg test
Time frame: Change from baseline at 4 weeks
Walking speed
Time frame: Change from baseline at 4 weeks
Step width
Time frame: Change from baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
Related trials for Cerebellar Ataxia
Active, not recruitingObservational study
Natural History of Spinocerebellar Ataxia Type 7 (SCA7)
Spinocerebellar Ataxia
Not yet recruiting
Cerebellar DBS in SCA1 and SCA3 Study
Spinocerebellar Ataxia Genotype Type 1, Spinocerebellar Ataxia Genotype Type 3
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
An Open-Label Study of CTI-1601 in Subjects With Friedreich's Ataxia
Friedreich Ataxia
RecruitingObservational study
Rare Disease Registry Database for Movement Disorders in Southern Anhui Province
Motor Neuron Diseases, Spinocerebellar Ataxias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming training and Physical therapy intervention in people with Cerebellar Ataxia, run by National Yang Ming Chiao Tung University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for the Assessment and Rating of Ataxia (time frame: Change from baseline at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.