Parkinson DiseaseNCT03774225
The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease
A study testing Virtual Reality with Manual and Verbal Guidance, Virtual Reality with No Manual and Verbal Guidance and Physical Therapy in people with Parkinson Disease, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo, Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in two groups: Experimental Group (EG), that performed the balance and gait training based on games from Microsoft Xbox Kinect System ®… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual Reality with Manual and Verbal Guidance, Virtual Reality with No Manual and Verbal Guidance and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Dec 2017to 20 Jul 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
- Active treatment with levodopa
- Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification
Who cannot join
- Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
- Severe respiratory and / or cardiovascular conditions
- Visual and / or auditory deficit that can not be corrected with orthotics;
- Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance;
- Previous experience with Microsoft XBOX Kinect® games;
- Be in rehab at another location concomitant with study training.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Brazil Parkinson Association
São Paulo, 04142-092
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
São Paulo, 05360-160
About this study
Official title: Effects Of Physiotherapy Intervention In A Motor Training With Virtual Reality On Motor, Cognitive, Balance And Gait Of Patients With Parkinson Disease: A Randomized Clinical Trial
A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo, Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in two groups: Experimental Group (EG), that performed the balance and gait training based on games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance (MVG) provided by a PT and a control group (CG) that performed an identical training with no MVG during the training.
Read the detailed description
It were recruited PPD in the "Brazil Parkinson Association" (BPA), a no-government association of PD care, where the assessments and intervention were performed from December 2017 to June 2018. The PPD were recruited by randomization from the BPA list of active patients and waiting list for PT intervention.
Outcome measures were obtained at up to three time points: before intervention, after 1 week and after 8 weeks of the end of intervention, the last time point was considered as a follow-up assessment. This study is in agreement with CONSORT guidelines for developing randomised trials . Primary measures was the functional balance evaluation by the Balance Evaluation Systems Test (BESTest) and Rapid Turn Test (RT Test), and gait performance assessed in the six-minute walk test and Gait test in 30 seconds. As secondary measures were used: Unified Parkinson's Disease Rate Scale (UPDRS), 5-Step Standing Passing Test (ST-DP5), International Falls Efficiency Scale (FES-I), Brazilian Version of the Freezing Scale March (FOGQ), Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Geriatric Depression Scale (GDS-15).
All patients performed 8 individual training sessions, under the supervision of a physiotherapist, twice a week for four weeks. Each session had 10 minutes of identical global exercises for both groups, consisting of stretching, muscle strengthening and axial mobility exercises, one serie per session. After these initial 10 minutes, both groups performed an additional 40 minutes of balance training using four XBOX games, four per session, under different conditions for MVG and NMVG.
While the Control Group will be trained by conventional Physical Therapy exercises.
- Conditions
- Parkinson Disease
- Being tested
- Virtual Reality with Manual and Verbal Guidance, Virtual Reality with No Manual and Verbal Guidance, Physical Therapy
- Keywords
- Virtual Reality, International Classification of Functioning, Disability and Health, Rehabilitation, Gait, Balance
- 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 Reality with Manual and Verbal GuidanceOther
Also called Experimental Group with Manual and Verbal Guidance (MVG)
Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.
Virtual Reality with No Manual and Verbal GuidanceOther
Also called Experimental Group with No Manual and Verbal Guidance (NMVG)
Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game.
Physical TherapyOther
Also called Control Group
Patients of the control group will be trained with balance exercises by a experient physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Manual and verbal guidance (MVG) | Experimental | The MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system® Receives: Other: Virtual Reality with Manual and Verbal Guidance; Other: Virtual Reality with No Manual and Verbal Guidance; Other: Physical Therapy |
| No manual and verbal guidance (NMVG) | Experimental | The NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern. Receives: Other: Virtual Reality with Manual and Verbal Guidance; Other: Virtual Reality with No Manual and Verbal Guidance; Other: Physical Therapy |
| Physical Therapy | Active comparator | The Control Group will be trained by conventional Physical Therapy exercises. Receives: Other: Virtual Reality with Manual and Verbal Guidance; Other: Virtual Reality with No Manual and Verbal Guidance; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional balance and gait with Best Test
A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability
Measured: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Change in Gait with 6 minut walk test
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
Measured: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Change in Functional balance with Rapid turn test
Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left).
Measured: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Secondary outcomes (3)
Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale
It's a scale composed of four parts: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications)
Measured: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Risk of falls with FES-I scale
presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry)
Measured: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Endurance with 6 minut walk test
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
Measured: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Dec 2017
- Primary completion30 Apr 2018
- Study completion20 Jul 2019 (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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Model description
- Prospective, single-blind, parallel-group, randomised trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Elisa P Piemonte, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774225
- Sponsor's protocol ID
- Pâmela e Amarílis
- Status last verified
- Jul 2018
- First submitted
- 5 Sep 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Physiotherapy Intervention In A Motor Training With Virtual Reality On Motor, Cognitive, Balance And Gait Of Patients With Parkinson Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03774225
- Acronym / sponsor ID
- Pâmela e Amarílis
- Conditions
- Parkinson Disease
- Keywords
- Virtual Reality, International Classification of Functioning, Disability and Health, Rehabilitation, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 20 Jul 2019 (estimated)
- First posted
- 12 Dec 2018 (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.
A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo, Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in two groups: Experimental Group (EG), that performed the balance and gait training based on games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance (MVG) provided by a PT and a control group (CG) that performed an identical training with no MVG during the training.
Detailed description
It were recruited PPD in the "Brazil Parkinson Association" (BPA), a no-government association of PD care, where the assessments and intervention were performed from December 2017 to June 2018. The PPD were recruited by randomization from the BPA list of active patients and waiting list for PT intervention.
Outcome measures were obtained at up to three time points: before intervention, after 1 week and after 8 weeks of the end of intervention, the last time point was considered as a follow-up assessment. This study is in agreement with CONSORT guidelines for developing randomised trials . Primary measures was the functional balance evaluation by the Balance Evaluation Systems Test (BESTest) and Rapid Turn Test (RT Test), and gait performance assessed in the six-minute walk test and Gait test in 30 seconds. As secondary measures were used: Unified Parkinson's Disease Rate Scale (UPDRS), 5-Step Standing Passing Test (ST-DP5), International Falls Efficiency Scale (FES-I), Brazilian Version of the Freezing Scale March (FOGQ), Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Geriatric Depression Scale (GDS-15).
All patients performed 8 individual training sessions, under the supervision of a physiotherapist, twice a week for four weeks. Each session had 10 minutes of identical global exercises for both groups, consisting of stretching, muscle strengthening and axial mobility exercises, one serie per session. After these initial 10 minutes, both groups performed an additional 40 minutes of balance training using four XBOX games, four per session, under different conditions for MVG and NMVG.
While the Control Group will be trained by conventional Physical Therapy exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Prospective, single-blind, parallel-group, randomised trial
| Arm | Type | Receives |
|---|---|---|
| Manual and verbal guidance (MVG) | Experimental | Other: Virtual Reality with Manual and Verbal Guidance, Other: Virtual Reality with No Manual and Verbal Guidance, Other: Physical TherapyThe MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system® |
| No manual and verbal guidance (NMVG) | Experimental | Other: Virtual Reality with Manual and Verbal Guidance, Other: Virtual Reality with No Manual and Verbal Guidance, Other: Physical TherapyThe NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern. |
| Physical Therapy | Active comparator | Other: Virtual Reality with Manual and Verbal Guidance, Other: Virtual Reality with No Manual and Verbal Guidance, Other: Physical TherapyThe Control Group will be trained by conventional Physical Therapy exercises. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
- Active treatment with levodopa
- Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification
Key exclusion criteria (6 listed)
- Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
- Severe respiratory and / or cardiovascular conditions
- Visual and / or auditory deficit that can not be corrected with orthotics;
- Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance;
- Previous experience with Microsoft XBOX Kinect® games;
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 with Manual and Verbal GuidanceAlso: Experimental Group with Manual and Verbal Guidance (MVG)Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist. | Other | Manual and verbal guidance (MVG), No manual and verbal guidance (NMVG), Physical Therapy |
| Virtual Reality with No Manual and Verbal GuidanceAlso: Experimental Group with No Manual and Verbal Guidance (NMVG)Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game. | Other | Manual and verbal guidance (MVG), No manual and verbal guidance (NMVG), Physical Therapy |
| Physical TherapyAlso: Control GroupPatients of the control group will be trained with balance exercises by a experient physiotherapist. | Other | Manual and verbal guidance (MVG), No manual and verbal guidance (NMVG), Physical Therapy |
Primary outcome
Change in Functional balance and gait with Best Test
Time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability
Change in Gait with 6 minut walk test
Time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
Change in Functional balance with Rapid turn test
Time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left).
3 secondary outcomes
Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale
Time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Risk of falls with FES-I scale
Time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Endurance with 6 minut walk test
Time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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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.
Maria Elisa P Piemonte principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality with Manual and Verbal Guidance, Virtual Reality with No Manual and Verbal Guidance and Physical Therapy in people with Parkinson Disease, run by University of Sao Paulo General Hospital at 2 sites 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 6 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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?
Change in Functional balance and gait with Best Test (time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)). 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 18 Feb 2019.