Parkinson DiseasePhase 2/3NCT01120392
Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease
A Phase 2/3 study testing treatment with Nintendo wii. and Physical therapy conventional. in people with Parkinson Disease, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life and motor performance in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- treatment with Nintendo wii. and Physical therapy conventional.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Oct 2011
- Phase
- Phase 2/3
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease
- Both the sex with age between 50 and 80 years
- To be in it I serve as apprentice of 1 the 3,0 in the scale of Hoehn Yahr
Who cannot join
- Cognitive impairment
- Poorly controlled arterial hypertension
- Poorly controlled Cardiopathy
Trial locations and contacts
1 site in 1 country.
About this study
Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life and motor performance in patients with Parkinson's disease.
Read the detailed description
The aim of this study is to assess if the treatment of rehabilitation with Nintendo wii is higher to the conventional in the quality of life and motor performance in patients with Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- treatment with Nintendo wii., Physical therapy conventional.
- Keywords
- Parkinson's disease, Physical therapy, Virtual Reality, Quality of life, Motor performance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with Nintendo wii.Other
Participants Will receive treatment with Nintendo Wii over one months. These Patients Will Be subjected to mobilization of stem and stretching. Then Will Be Submitted to Nintendo wii games. Will Be Submitted This group three times a week to a treatment protocol with boxing exercises with wii sports and wii fit
Physical therapy conventional.Other
Conventional exercises used with the same goals for the group with wii
| Study group | Role | What they receive |
|---|---|---|
| Treatment group - Nintendo wii. | Experimental | Not described Receives: Other: treatment with Nintendo wii. |
| conventional - Physical Therapy | Active comparator | Not described Receives: Other: Physical therapy conventional. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Parkinson's disease questionnaire (PDQ-39)
Measured: 4 weeks (Baseline and after four weeks)
Motor performance
the Unified Parkinson's Disease Rating Scale (UPDRS.)
Measured: 4 weeks (Baseline and after four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ailton de Souza Melo, Federal University of Bahia
- Investigators
- Ailton Melo, PhD, Principal investigator, UFBA- DINEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120392
- Sponsor's protocol ID
- DNEP
- Status last verified
- Dec 2011
- First submitted
- 10 May 2010
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01120392
- Acronym / sponsor ID
- DNEP
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Physical therapy, Virtual Reality, Quality of life, Motor performance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 May 2010 (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.
Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life and motor performance in patients with Parkinson's disease.
Detailed description
The aim of this study is to assess if the treatment of rehabilitation with Nintendo wii is higher to the conventional in the quality of life and motor performance in patients 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 |
|---|---|---|
| Treatment group - Nintendo wii. | Experimental | Other: treatment with Nintendo wii. |
| conventional - Physical Therapy | Active comparator | Other: Physical therapy conventional. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Parkinson's disease
- Both the sex with age between 50 and 80 years
- To be in it I serve as apprentice of 1 the 3,0 in the scale of Hoehn Yahr
Key exclusion criteria (3 listed)
- Cognitive impairment
- Poorly controlled arterial hypertension
- Poorly controlled Cardiopathy
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 |
|---|---|---|
| treatment with Nintendo wii.Participants Will receive treatment with Nintendo Wii over one months. These Patients Will Be subjected to mobilization of stem and stretching. Then Will Be Submitted to Nintendo wii games. Will Be Submitted This group three times a week to a treatment protocol with boxing exercises with wii sports and wii fit | Other | Treatment group - Nintendo wii. |
| Physical therapy conventional.Conventional exercises used with the same goals for the group with wii | Other | conventional - Physical Therapy |
Primary outcome
Quality of life
Time frame: 4 weeks (Baseline and after four weeks)
Parkinson's disease questionnaire (PDQ-39)
Motor performance
Time frame: 4 weeks (Baseline and after four weeks)
the Unified Parkinson's Disease Rating Scale (UPDRS.)
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 7 Dec 2011.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
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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.
Ailton Melo, PhD principal investigator
UFBA- DINEP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing treatment with Nintendo wii. and Physical therapy conventional. in people with Parkinson Disease, run by Federal University of Bahia at 1 site in Brazil.
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 3 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 7 Dec 2011. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of life (time frame: 4 weeks (Baseline and after four weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01120392, which also lists 2 linked publications.
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 7 Dec 2011.