Parkinson DiseaseNCT04717271
Effects of Kinesthetic Stimuli During XBOX Kinect Training on People With Parkinson's Disease
A study testing Movement Guidance Group and No Movement Guidance Group in people with Parkinson Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
A single-blind, parallel-group, randomised trial will be conducted in Sao Paulo, Brazil. People with Parkinson's Disease (PD) will be recruited at "Brazil Parkinson Association" (BPA), a non-governmental association of PD care, and randomly allocated in two groups: the Movement Guidance Group (MVG) and NO-MVG Group. 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?
- Movement Guidance Group and No Movement Guidance Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2020to 16 Dec 2021
- 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
- Idiopathic Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
- Active treatment with levodopa
- Stages 1, 2, and 3 according to Hoehn and Yahr Classification
Who cannot join
- Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
- Score greater than or equal to 6 on the geriatric depression scale
- Severe respiratory and / or cardiovascular conditions
- Visual and / or auditory deficit that cannot be corrected with glasses or a hearing aid;
- 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
- And being in rehabilitation in another location concomitant to this training.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
São Paulo, São Paulo, 05360-160
About this study
Official title: Effects of Kinesthetic Stimuli Provided by the Physiotherapist During XBOX Kinect Training on the Functionality of People With Parkinson's Disease: A Blind Randomized Clinical Trail
A single-blind, parallel-group, randomised trial will be conducted in Sao Paulo, Brazil. People with Parkinson's Disease (PD) will be recruited at "Brazil Parkinson Association" (BPA), a non-governmental association of PD care, and randomly allocated in two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will perform XBOX Kinect training for balance and gait. However, the MVG will receive kinesthetic stimuli manually by the physiotherapist (PT) to improve the participant movements while the NO-MVG Group will not, the presence of the PT will be restrict to only guarantee the participant safety.
Read the detailed description
BACKGROUND: Despite evidences indicate the benefit of motor interventions based on video games in people with Parkinson's Disease (PD), practice guidelines for the therapeutic use in physiotherapy were still not established. Although visual and auditory stimuli provided by video games are pointed as one of the main advantages for their therapeutic use, the effects of kinesthetic stimuli offered through physical therapist manual intervention during this type of training in people with PD have not been investigated yet. The answer to this question is relevant to guide the physical therapist (PT) conduct during this kind of intervention.
PURPOSE: To compare the effects of motor training using video games with and without kinesthetic stimuli offered by physical therapist manual guidance during intervention on the functionality of people with PD.
METHODS: A blind randomized clinical trial in people with idiopathic PD, staging of 1 to 3 according to disability scale of Hoehn and Yahr, will be performed. Participants will be randomized into two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will receive 8 individual sessions, twice a week, for 4 weeks. Each session consist of 10 minutes of warm-up and 40 minutes of XBOX Kinect training for balance and gait. In the MVG Group, the PT will provide kinesthetic stimuli by assisting manually the participant movements. In the NO-MVG Group, the involvement of the PT will be restricted to ensure participant safety. The two groups will be evaluated before (BT) and after (AT) training and after 60 days (follow-up). A blind physiotherapist will conduct the assessments. Measurements are categorized according to the International Functioning Classification (ICF), those associated with the activity level were established as primary measures: Balance Evaluation Systems Test (BESTest); International Falls Effectiveness Scale (FES-I); 30-second Gait Test; Six Minute Walk Distance (6MWD); Five Times Sit to Stand Test (FTSTS) and Unified Parkinson's Disease Rate Scale (UPDRS) session II. Secondary measures were the evaluation of function using UPDRS session III; Rapid Turns Test (RTT); Montreal Cognitive Assessment (MOCA); Geriatric Depression Scale (GDS-15), and participation using the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).
STATISTICAL ANALYSIS: An ANOVA to repeated measures will be use, having as factors: group (MVG Group and NO-MVG Group) and evaluations (BT, AT and FU). Followed by post hoc Tukey Test to the significance factors. A significance of 5% will be considered.
- Conditions
- Parkinson Disease
- Being tested
- Movement Guidance Group, No Movement Guidance Group
- Keywords
- Parkinson's Disease, Physical Therapy Specialty, Virtual Reality, International Classification of Functioning, Disability and Health, Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement Guidance GroupOther
Also called MVG
Participants of the MVG will received kinesthetic stimuli by manual assistance of the physiotherapist, which has the intention of guiding and improving the quality of movement during XBOX Kinect training for balance and gait.
Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames.
No Movement Guidance GroupOther
Also called NO-MVG
Participants of the NO-MVG will not received kinesthetic stimuli by manual assistance of the physiotherapist during XBOX Kinect training for balance and gait.
They will perform the exercises without any manual correction. Although, the physiotherapist will be present during all session to ensure their safety.
Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames.
| Study group | Role | What they receive |
|---|---|---|
| Movement Guidance Group (MVG) | Experimental | In the MVG Group, the physiotherapist will provide kinesthetic stimuli by assisting manually the participant movements. Receives: Other: Movement Guidance Group |
| No Movement Guidance Group (NO-MVG) | Experimental | In the NO-MVG, the involvement of the physiotherapist will be restricted to guarantee the safety of the participant. Receives: Other: No Movement Guidance Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Evaluation Systems Test (BESTest)
Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
Measured: Change from baseline up to 3 months
International Falls Effectiveness Scale (FES-I)
It 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: Change from baseline up to 3 months
30-second Gait Test
Functional mobility test that assesses gait performance under the influence of a verbal fluency cognitive task (speaking as many words that start with a certain letter established by the evaluator), in which the individual must walk continuously for 30 seconds and, when multitasking, he or she is instructed to perform both without interruption (command = "perform both tasks at the same time, without stopping talking or walking"). The evaluator measures the distance that the subject was able to travel in a single task and in a double task.
Measured: Change from baseline up to 3 months
Six Minute Walk Distance
A gait assessment method that measures the maximum distance a person can walk in six minutes and measures maximal cardiorespiratory functions.
Measured: Change from baseline up to 3 months
Five Times Sit to Stand
A measure of functional mobility that assists in the identification of insufficient strength and muscle strength of the lower limbs, assessing balance and identifying people at risk of falls. In this task, the individual is instructed to sit and get up from a chair, without armrests, for 5 times without stopping as quickly as possible. The evaluator measures the time the subject performs this task.
Measured: Change from baseline up to 3 months
Unified Parkinson Disease Rating Scale - Session II
It is a gold standard scale used to assess and monitor PD progression. It consists of 42 items and divided into four segments: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications). a score from 0 to 4 is established, the lower the score the better the individual's condition. In Part II, the questions are conducted by the evaluator and the answers are based on the self-reported report by the evaluated person regarding his motor performance in daily life activities.
Measured: Change from baseline up to 3 months
Secondary outcomes (4)
Unified Parkinson Disease Rating Scale - Session III
In session III of the UPDRS, the motor function is assessed, unlike session II which the score from 0 to 4 is given according to the individual's perception of his or her own performance, in this part the score is given according to the clinical motor analysis of the therapist. The higher the score, the worse the state of motor performance.
Measured: Change from baseline up to 3 months
Rapid Turns Test
Measure of evaluation of the function related to the gait pattern, specifically to assess presence of episode of freezing of gait.
The subject turns in a complete circle (360 degrees) as fast as he or she can while being timed to finish it. The test is done to both sides (right and left).
Measured: Change from baseline up to 3 months
Geriatric Depression Scale
It is a test for detecting depressive symptoms in the elderly, with 15 questions in which the result of 5 or more points shows a sign of depression, with a score equal to or greater than 11 characterizing severe depression.
Measured: Change from baseline up to 3 months
Montreal Cognitive Assessment
The instrument assesses different cognitive domains such as visuospatial and executive functions, naming, memory, attention, language, abstraction and orientation. The total score of the scale is 30 points and scores greater than or equal to 26 indicate normal performance.
Measured: Change from baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start30 Nov 2020
- Primary completion31 Aug 2021
- Study completion16 Dec 2021
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
- A single-blind, parallel-group and randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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, PT, PhD, Study director, University of Sao PauloPâmela Y Igarasi Barbosa, PT, Principal investigator, University of Sao PauloAmarilis Falconi, PT, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717271
- Sponsor's protocol ID
- Pâmela
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2021
- Last updated
- 31 Jan 2023
- 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 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesthetic Stimuli Provided by the Physiotherapist During XBOX Kinect Training on the Functionality of People With Parkinson's Disease: A Blind Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT04717271
- Acronym / sponsor ID
- Pâmela
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Physical Therapy Specialty, Virtual Reality, International Classification of Functioning, Disability and Health, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 22 Jan 2021 (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 single-blind, parallel-group, randomised trial will be conducted in Sao Paulo, Brazil. People with Parkinson's Disease (PD) will be recruited at "Brazil Parkinson Association" (BPA), a non-governmental association of PD care, and randomly allocated in two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will perform XBOX Kinect training for balance and gait. However, the MVG will receive kinesthetic stimuli manually by the physiotherapist (PT) to improve the participant movements while the NO-MVG Group will not, the presence of the PT will be restrict to only guarantee the participant safety.
Detailed description
BACKGROUND: Despite evidences indicate the benefit of motor interventions based on video games in people with Parkinson's Disease (PD), practice guidelines for the therapeutic use in physiotherapy were still not established. Although visual and auditory stimuli provided by video games are pointed as one of the main advantages for their therapeutic use, the effects of kinesthetic stimuli offered through physical therapist manual intervention during this type of training in people with PD have not been investigated yet. The answer to this question is relevant to guide the physical therapist (PT) conduct during this kind of intervention.
PURPOSE: To compare the effects of motor training using video games with and without kinesthetic stimuli offered by physical therapist manual guidance during intervention on the functionality of people with PD.
METHODS: A blind randomized clinical trial in people with idiopathic PD, staging of 1 to 3 according to disability scale of Hoehn and Yahr, will be performed. Participants will be randomized into two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will receive 8 individual sessions, twice a week, for 4 weeks. Each session consist of 10 minutes of warm-up and 40 minutes of XBOX Kinect training for balance and gait. In the MVG Group, the PT will provide kinesthetic stimuli by assisting manually the participant movements. In the NO-MVG Group, the involvement of the PT will be restricted to ensure participant safety. The two groups will be evaluated before (BT) and after (AT) training and after 60 days (follow-up). A blind physiotherapist will conduct the assessments. Measurements are categorized according to the International Functioning Classification (ICF), those associated with the activity level were established as primary measures: Balance Evaluation Systems Test (BESTest); International Falls Effectiveness Scale (FES-I); 30-second Gait Test; Six Minute Walk Distance (6MWD); Five Times Sit to Stand Test (FTSTS) and Unified Parkinson's Disease Rate Scale (UPDRS) session II. Secondary measures were the evaluation of function using UPDRS session III; Rapid Turns Test (RTT); Montreal Cognitive Assessment (MOCA); Geriatric Depression Scale (GDS-15), and participation using the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).
STATISTICAL ANALYSIS: An ANOVA to repeated measures will be use, having as factors: group (MVG Group and NO-MVG Group) and evaluations (BT, AT and FU). Followed by post hoc Tukey Test to the significance factors. A significance of 5% will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A single-blind, parallel-group and randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Movement Guidance Group (MVG) | Experimental | Other: Movement Guidance GroupIn the MVG Group, the physiotherapist will provide kinesthetic stimuli by assisting manually the participant movements. |
| No Movement Guidance Group (NO-MVG) | Experimental | Other: No Movement Guidance GroupIn the NO-MVG, the involvement of the physiotherapist will be restricted to guarantee the safety of the participant. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
- Active treatment with levodopa
- Stages 1, 2, and 3 according to Hoehn and Yahr Classification
Key exclusion criteria (7 listed)
- Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
- Score greater than or equal to 6 on the geriatric depression scale
- Severe respiratory and / or cardiovascular conditions
- Visual and / or auditory deficit that cannot be corrected with glasses or a hearing aid;
- Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance
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 |
|---|---|---|
| Movement Guidance GroupAlso: MVGParticipants of the MVG will received kinesthetic stimuli by manual assistance of the physiotherapist, which has the intention of guiding and improving the quality of movement during XBOX Kinect training for balance and gait. Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames. | Other | Movement Guidance Group (MVG) |
| No Movement Guidance GroupAlso: NO-MVGParticipants of the NO-MVG will not received kinesthetic stimuli by manual assistance of the physiotherapist during XBOX Kinect training for balance and gait. They will perform the exercises without any manual correction. Although, the physiotherapist will be present during all session to ensure their safety. Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames. | Other | No Movement Guidance Group (NO-MVG) |
Primary outcome
Balance Evaluation Systems Test (BESTest)
Time frame: Change from baseline up to 3 months
Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
International Falls Effectiveness Scale (FES-I)
Time frame: Change from baseline up to 3 months
It 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).
30-second Gait Test
Time frame: Change from baseline up to 3 months
Functional mobility test that assesses gait performance under the influence of a verbal fluency cognitive task (speaking as many words that start with a certain letter established by the evaluator), in which the individual must walk continuously for 30 seconds and, when multitasking, he or she is instructed to perform both without interruption (command = "perform both tasks at the same time, without stopping talking or walking"). The evaluator measures the distance that the subject was able to travel in a single task and in a double task.
Six Minute Walk Distance
Time frame: Change from baseline up to 3 months
A gait assessment method that measures the maximum distance a person can walk in six minutes and measures maximal cardiorespiratory functions.
Five Times Sit to Stand
Time frame: Change from baseline up to 3 months
A measure of functional mobility that assists in the identification of insufficient strength and muscle strength of the lower limbs, assessing balance and identifying people at risk of falls. In this task, the individual is instructed to sit and get up from a chair, without armrests, for 5 times without stopping as quickly as possible. The evaluator measures the time the subject performs this task.
Unified Parkinson Disease Rating Scale - Session II
Time frame: Change from baseline up to 3 months
It is a gold standard scale used to assess and monitor PD progression. It consists of 42 items and divided into four segments: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications). a score from 0 to 4 is established, the lower the score the better the individual's condition. In Part II, the questions are conducted by the evaluator and the answers are based on the self-reported report by the evaluated person regarding his motor performance in daily life activities.
4 secondary outcomes
Unified Parkinson Disease Rating Scale - Session III
Time frame: Change from baseline up to 3 months
Rapid Turns Test
Time frame: Change from baseline up to 3 months
Geriatric Depression Scale
Time frame: Change from baseline up to 3 months
Montreal Cognitive Assessment
Time frame: Change from baseline up to 3 months
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 31 Jan 2023.
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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, PT, PhD study director
University of Sao Paulo
Pâmela Y Igarasi Barbosa, PT principal investigator
University of Sao Paulo
Amarilis Falconi, PT principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement Guidance Group and No Movement Guidance Group in people with Parkinson Disease, run by University of Sao Paulo General Hospital 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 7 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 31 Jan 2023. 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.
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?
Balance Evaluation Systems Test (BESTest) (time frame: Change from baseline up to 3 months). The study lists 6 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 31 Jan 2023.