Parkinson DiseaseNCT04117737
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
A study testing Virtual reality combined with anti-gravity treadmill in people with Parkinson Disease and Gait Disorders, Neurologic, run by Universidad San Jorge at 1 site in Spain.
Trial summary
The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Virtual reality combined with anti-gravity treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2019to 30 Dec 2019
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having Parkinson's disease diagnosed by a neurological doctor.
- Having an alteration of the gait caused by the neurological disorder.
- Being able to have an independent and voluntary walk of 10 meters as minimum.
- Height more than 150 cm.
Who cannot join
- Being blind.
- Medical contraindications for walking.
- Being amputee.
- Alcohol or drugs abuse.
- Other diseases that impedes the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study
The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Virtual reality combined with anti-gravity treadmill
- Keywords
- Parkinson, Virtual reality, Anti-gravity treadmill, Rehabilitation, Gait disorders
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality combined with anti-gravity treadmillOther
The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.
The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Single-arm Receives: Other: Virtual reality combined with anti-gravity treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gait autonomy
Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface.
Measured: Baseline and 4-weeks
Secondary outcomes (3)
Changes in gait speed
Changes in gait speed will be measured by 10-Meter Walk Test (10MWT). The 10MWT consists of asking the subject to walk a 14m distance on flat area and measure the time spent from meter 2 to meter 12. Time will be measured by a digital chronometer. Gait speed will be calculated in meter per second.
Measured: Baseline and 4-weeks
Changes in balance and gait ability
Changes in balance and gait ability will be measured by Tinetti scale. The Tinetti test is a simple, reproducible way of assessing the risk of falling in the elderly. This scale is composed of two value, static and dynamic: the test grants a maximum of 16 points for static part (sitting) and 12 point for dynamic (walking) part. Higher is the score, better is the performance.
Measured: Baseline and 4-weeks
Changes in quality of life
Changes in quality of life will be measured by by 36-Item Short-Form Health Survey (SF-36). SF-36 assesses 8 physical and mental health domains: 1) Physical Functioning, 2) Social Functioning, 3) Role-Physical, 4) Bodily Pain, 5) Mental Health), 6) Role-Emotional, 7) Vitality, and 8) General Health. For each scale, item scores are coded, summed, and transformed, with final values expressed as a percentage, ranging from 0 (worst health) to 100 (best health).
Measured: Baseline and 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start30 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Dec 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Herrero, PhD, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117737
- Sponsor's protocol ID
- PI18/386
- Status last verified
- Dec 2019
- First submitted
- 3 Oct 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plan on sharing data from this study with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT04117737
- Acronym / sponsor ID
- PI18/386
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- Parkinson, Virtual reality, Anti-gravity treadmill, Rehabilitation, Gait disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 7 Oct 2019 (actual)
- 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 aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual reality combined with anti-gravity treadmillSingle-arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having Parkinson's disease diagnosed by a neurological doctor.
- Having an alteration of the gait caused by the neurological disorder.
- Being able to have an independent and voluntary walk of 10 meters as minimum.
- Height more than 150 cm.
Key exclusion criteria (5 listed)
- Being blind.
- Medical contraindications for walking.
- Being amputee.
- Alcohol or drugs abuse.
- Other diseases that impedes the intervention.
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 reality combined with anti-gravity treadmillThe system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system. The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life. | Other | Intervention |
Primary outcome
Changes in gait autonomy
Time frame: Baseline and 4-weeks
Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface.
3 secondary outcomes
Changes in gait speed
Time frame: Baseline and 4-weeks
Changes in balance and gait ability
Time frame: Baseline and 4-weeks
Changes in quality of life
Time frame: Baseline and 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 28 Jan 2020.
- Individual participant dataSharing planned: No. There are currently no plan on sharing data from this study with other researchers.
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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.
Pablo Herrero, PhD principal investigator
Universidad San Jorge
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 combined with anti-gravity treadmill in people with Parkinson Disease and Gait Disorders, Neurologic, run by Universidad San Jorge at 1 site in Spain.
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 5 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 28 Jan 2020. 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 Spain. 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?
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?
Changes in gait autonomy (time frame: Baseline and 4-weeks). 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 28 Jan 2020.