Parkinson DiseaseNCT02516644
Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease
A study testing Virtual Reality and Conventional Therapy in people with Parkinson Disease, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual Reality and Conventional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Dec 2018
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- idiopathic Parkinson Disease diagnosis
- age under 80 years
- severity of disease rated 2 or 3 at Hoehn \& Yahr scale
Who cannot join
- impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
- neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
- severe Levodopa dyskinesia
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ferrara University Hospital
Ferrara, 44124
Sofia Straudi, MD, PhD, 0532238720, s.straudi@ospfe.it
Sofia Straudi, MD, PhD
About this study
Official title: Feasibility and Effectiveness of Virtual Reality and the Use of Body Weight Support Treadmill Training in Parkinson's Disease: an Explorative Study
The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease
- Conditions
- Parkinson Disease
- Being tested
- Virtual Reality, Conventional Therapy
- Keywords
- Parkinson Disease, Mobility, Balance, Virtual Reality, treadmill training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
12 sessions of 1 hour (30 min of virtual reality and 30 min of aerobic exercise with treadmill training): three times a week over four weeks
Conventional TherapyBehavioural
12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Xbox Kinect + treadmill training Receives: Behavioral: Virtual Reality |
| Conventional Therapy | Active comparator | Specific conventional training for Parkinson's Disease Receives: Behavioral: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walking Test
The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary.
Measured: up to weeks 16
Secondary outcomes (6)
Berg Balance Scale
This is an assessment scale of ability to maintain balance, or statically or while performing functional movement, including 14 observable tasks common to everyday life measured on a 5 point ordinal scale.
Measured: weeks: 0,4, 16
Time Up and Go Test
Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch.
Measured: weeks: 0,4, 16
10 meter walk test
Assesses walking speed in meters per second over a short duration
Measured: weeks: 0,4, 16
Unified Parkinson's Disease Rating Scale
It is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease across the longitudinal disease course and provide a clinical endpoint in therapy trials.
Measured: weeks: 0,4, 16
Postural sway (Center of pressure (COP) trajectories)
Center of pressure (COP) trajectories
Measured: weeks: 0,4, 16
Metabolic measurements by Near infrared spectroscopy
Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks
Measured: weeks: 0,4, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Straudi, MD, Principal investigator, Ferrara Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516644
- Sponsor's protocol ID
- Parkinson_Xbox
- Status last verified
- Nov 2017
- First submitted
- 4 Aug 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Virtual Reality and the Use of Body Weight Support Treadmill Training in Parkinson's Disease: an Explorative Study
- ClinicalTrials.gov ID
- NCT02516644
- Acronym / sponsor ID
- Parkinson_Xbox
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Mobility, Balance, Virtual Reality, treadmill training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Aug 2015 (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 primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Behavioral: Virtual RealityXbox Kinect + treadmill training |
| Conventional Therapy | Active comparator | Behavioral: Conventional TherapySpecific conventional training for Parkinson's Disease |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- idiopathic Parkinson Disease diagnosis
- age under 80 years
- severity of disease rated 2 or 3 at Hoehn \& Yahr scale
Key exclusion criteria (4 listed)
- impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
- neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
- severe Levodopa dyskinesia
- pregnancy
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 |
|---|---|---|
| Virtual Reality12 sessions of 1 hour (30 min of virtual reality and 30 min of aerobic exercise with treadmill training): three times a week over four weeks | Behavioural | Virtual reality |
| Conventional Therapy12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks | Behavioural | Conventional Therapy |
Primary outcome
Six-Minute Walking Test
Time frame: up to weeks 16
The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary.
6 secondary outcomes
Berg Balance Scale
Time frame: weeks: 0,4, 16
Time Up and Go Test
Time frame: weeks: 0,4, 16
10 meter walk test
Time frame: weeks: 0,4, 16
Unified Parkinson's Disease Rating Scale
Time frame: weeks: 0,4, 16
Postural sway (Center of pressure (COP) trajectories)
Time frame: weeks: 0,4, 16
Metabolic measurements by Near infrared spectroscopy
Time frame: weeks: 0,4, 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Sofia Straudi, MD principal investigator
Ferrara Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Conventional Therapy in people with Parkinson Disease, run by University Hospital of Ferrara at 1 site in Italy.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Straudi, MD (+390532238720, s.straudi@ospfe.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walking Test (time frame: up to weeks 16). 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 20 Nov 2017.