Parkinson DiseaseNCT04796246
Leap Motion Controller on the Functionality of Upper Limbs in Parkinson's Disease
A study testing Conventional Physiotherapy in people with Parkinson Disease and Upper Extremity Dysfunction, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Is treatment with the Leap Motion Controller device effective for upper limb functionality in individuals with Parkinson's Disease? The present study presents two hypotheses: True hypothesis: There is an improvement in the functionality of MMSS after intervention with virtual reality? Null hypothesis: There is no… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Upper Extremity Dysfunction, Therapy-Related MDS
- What is being tested?
- Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2022to 1 Aug 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parkinson's disease diagnostic;
- Classified as I-III on the Hoehn \& Yahr motor staging scale;
- Are over 18 years old (above this, without age restriction).
- Residents in the city of Porto Alegre / RS.
- Have signed an informed consent form.
Who cannot join
- Do not show the understanding of the games on the first day of familiarization;
- Have a cerebral pacemaker implant;
- Have recent injuries or limitations that make the MMSS impossible.
- Do not perform / abstain from two appointments out of the 16 proposed in the intervention protocol, regardless of the group that will be allocated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leap Motion Controller on the Functionality Of Upper Limbs in Parkinson's Disease: A Randomized Clinical Trial
Is treatment with the Leap Motion Controller device effective for upper limb functionality in individuals with Parkinson's Disease?
The present study presents two hypotheses:
True hypothesis: There is an improvement in the functionality of MMSS after intervention with virtual reality? Null hypothesis: There is no improvement in the functionality of MMSS after intervention with virtual reality? The proposed work will be characterized as a Randomized Clinical Trial, with evaluators outside the experimental groups (single-blind). The sample will be probabilistic, from individuals diagnosed with Parkinson's disease.
Read the detailed description
STUDY METHODOLOGY
- RESEARCH DESIGN: The proposed work will be characterized as a Randomized Clinical Trial, with evaluators outside the experimental groups (single-blind). The sample will be probabilistic, from individuals diagnosed with Parkinson's disease.
- TYPE OF STUDY: Randomized Clinical Trial.
- AREA OF SCOPE: Major area: Health Sciences. Area: Physiotherapy and Occupational Therapy.
- LOCATION: The place where the entire study will be carried out will be in the home environment of each research participant.
- PARTICIPANTS: Participants will be recruited from an existing pre-existing list of research conducted on individuals with Parkinson's Disease from the UFCSPA. Individuals who: - are diagnosed with Parkinson's disease; - Classified as I-III on the Hoehn \& Yahr motor staging scale; - Are over 18 years old (above this, without age restriction). - Residents in the city of Porto Alegre / RS. - Have signed the informed consent form (Appendix A). Individuals who: - Do not show the understanding of the games on the first day of familiarization; - Have a cerebral pacemaker implant; - Have recent injuries or limitations that make the MMSS impossible. - Do not perform / abstain from two appointments out of the 16 proposed in the intervention protocol, regardless of the group that will be allocated. The study will consist of two groups: intervention group (IG), which will receive treatment with Leap Motion Controller; and the control group (CG), who will receive treatment with conventional physiotherapy.
- EVALUATION INSTRUMENTS: A participant identification form will be filled out, containing full name, date of birth, gender, address, telephone number, education, diagnosis, time of diagnosis, onset of symptoms (laterality), associated diseases, PD subtype and medicines. Individuals will be assessed for: the motor aspects of experiences and activities of daily living using the TEMPA test and the Unified Assessment Scale for Parkinson's Disease (MDS-UPDRS) part II; Motor Assessment and subtype of the disease, using the MDS-UPDRS scale III; motor staging of PD using the Hoehn \& Yahr scale; muscle strength and endurance, using the handgrip dynamometer (TEMPA test); manual dexterity, through the Box and Block test and the Nine Hole Peg test; cognitive issues through the Montreal Cognitive Assessment (MoCA); and quality of life, through the Questionnaire on Parkinson's Disease (PDQ-39).
- EXPECTED DURATION: The present research project contemplates different objectives, this being a study proposal to be developed during four years.
- PROCEDURES: The formation of each of the groups will be done through the generation of a random sequence through the tool available at http://www.randomize.com. Therefore, individuals will be divided into two groups: Intervention Group and Control Group. Subsequently, the initial assessment will be made,TEMPA, MDS-UPDRS-II e III, motor staging of the disease (H\&Y), Box and Block Test, Nine Hole Peg Test), MoCA and PDQ-39.The IG will carry out a 2-month intervention protocol, with 16 40-minute interventions, twice a week. The CG will perform a conventional physiotherapy protocol for the same period as the IG. Therefore, all groups will receive the same evaluation procedures that will be performed before the intervention (PRE), after the intervention (POST) and, finally, 30 days after the intervention (follow-up). The researchers responsible for the intervention will not be aware of the evaluations carried out and the evaluators will not be aware of the group to which the participant will belong. Both groups will be able to follow their routine activities (physical and / or physical therapy) and all procedures will be performed in the home environment of each research participant.
- ETHICAL AND LEGAL PROCEDURES The study project in question will be submitted to the Research Ethics Committee of the Federal University of Health Sciences of Porto Alegre (UFCSPA) and will only be applied after due approval. All participants will be informed about the procedures, objectives, justifications, potential risks and benefits of their participation in the study. The research will not present risks to the participant, but if there is any discomfort during any activity, the treatment will be stopped immediately and the necessary measures taken. In addition, all participants must sign the informed consent form and receive a copy of it. The use of any type of image will not identify the participant and will only be used with written consent. The data in the medical record (name, telephone and address) will be used for screening in the identification and contact of individuals and stored in a database that will be accessed only by researchers.
- Being tested
- Leap Motion Controller, Conventional Physiotherapy
- Keywords
- Parkinson Disease, Upper Extremity Disfunction, Therapy-Related MDS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leap Motion ControllerOther
Training with the Leap Motion Controller instrument will be carried out first for 5 minutes, for a presentation and interaction of the virtual immersion with it, in the initial meeting. After the second meeting, the attendance protocol will be 16 sessions, this time being distributed as: first game lasting 7 minutes, second and third games lasting 6 minutes each and the last game lasting 8 minutes, totaling 27 minutes of intervention. Between games it was adopted about 2 minutes of rest.
Conventional PhysiotherapyOther
The conventional physiotherapy intervention will be based on the same activities developed (MMSS movements) of the IG: - First, attach pins with magnets with moving disc and after 1 minute and 25 seconds remove flower petals from inside a tube. The movements performed will be fine motricity, related to the tweezers handling (thumb and forefinger), alternating hands after 2 minutes and 30 minutes of play; - Hitting your hands on suddenly raised rulers, performing bilateral flexion / extension movements of the wrist simultaneously and alternating hands after 2 minutes and 30 minutes of play.
| Study group | Role | What they receive |
|---|---|---|
| Leap Motion Controller | Experimental | Intervention Group: which will receive treatment with Leap Motion Controller Receives: Other: Leap Motion Controller; Other: Conventional Physiotherapy |
| Conventional Physiotherapy | Active comparator | Control Group: who will receive treatment with conventional physiotherapy. Receives: Other: Leap Motion Controller; Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test TEMPA (Test d'Évaluation des Membres Supérieurs de Personnes Agées)
It is an instrument that serves to assess the degree of disability of the MMSS. It presents a manual on how to manage it, the necessary measures to make the box and where to dispose of each specific material of the tasks. The materials required for administering the test are as follows: 100 gram coffee pot, 1000 milliliter water jar, coffee spoon, cup, water glass, medicine bottle and 10 placebo capsules, white envelopes, seal, pencil , card game, coins (R $ 1, R $ 0.25, R $ 0.50, R $ 0.10), small glass jar (7 cm (cm) in diameter and 5 cm in height), small objects (toothpick, nut, safety pin, 2.5 cm diameter button and nail), piece of non-slip material and sheets for recording scores (MICHAELSEN et al., 2008). The test consists of performing bilateral and unilateral tasks, of the upper limbs.
Measured: Pre and Post Immediate intervention. 30 days after interventions.
Secondary outcomes (1)
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The updated MDS-UPDRS scale comprises four parts: Part I, the impact of non-motor aspects of daily life, part II, motor aspects of daily life, part III, motor assessment and part IV that corresponds to motor complications. However, only part II - motor aspects of daily life will be applied, which is designed to be a self-administered questionnaire, but can be reviewed by the researcher to ensure its clear and complete completion. And part III - motor evaluation, in which it has instructions for the evaluator to provide or demonstrate to the individual and is completed by the evaluator. A higher score corresponds to a corresponding worse state.
Measured: Pre and Post Immediate intervention. 30 days after interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start15 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Aug 2023
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
- Crossover
- Model description
- The proposed work will be characterized as a Randomized Clinical Trial, with evaluators outside the experimental groups (single-blind). The sample will be probabilistic, from individuals diagnosed with Parkinson's disease.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Cechetti, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796246
- Sponsor's protocol ID
- 24443019.7.0000.5345
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leap Motion Controller on the Functionality Of Upper Limbs in Parkinson's Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04796246
- Acronym / sponsor ID
- 24443019.7.0000.5345
- Keywords
- Parkinson Disease, Upper Extremity Disfunction, Therapy-Related MDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 12 Mar 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.
Is treatment with the Leap Motion Controller device effective for upper limb functionality in individuals with Parkinson's Disease?
The present study presents two hypotheses:
True hypothesis: There is an improvement in the functionality of MMSS after intervention with virtual reality? Null hypothesis: There is no improvement in the functionality of MMSS after intervention with virtual reality? The proposed work will be characterized as a Randomized Clinical Trial, with evaluators outside the experimental groups (single-blind). The sample will be probabilistic, from individuals diagnosed with Parkinson's disease.
Detailed description
STUDY METHODOLOGY
- RESEARCH DESIGN: The proposed work will be characterized as a Randomized Clinical Trial, with evaluators outside the experimental groups (single-blind). The sample will be probabilistic, from individuals diagnosed with Parkinson's disease.
- TYPE OF STUDY: Randomized Clinical Trial.
- AREA OF SCOPE: Major area: Health Sciences. Area: Physiotherapy and Occupational Therapy.
- LOCATION: The place where the entire study will be carried out will be in the home environment of each research participant.
- PARTICIPANTS: Participants will be recruited from an existing pre-existing list of research conducted on individuals with Parkinson's Disease from the UFCSPA. Individuals who: - are diagnosed with Parkinson's disease; - Classified as I-III on the Hoehn \& Yahr motor staging scale; - Are over 18 years old (above this, without age restriction). - Residents in the city of Porto Alegre / RS. - Have signed the informed consent form (Appendix A). Individuals who: - Do not show the understanding of the games on the first day of familiarization; - Have a cerebral pacemaker implant; - Have recent injuries or limitations that make the MMSS impossible. - Do not perform / abstain from two appointments out of the 16 proposed in the intervention protocol, regardless of the group that will be allocated. The study will consist of two groups: intervention group (IG), which will receive treatment with Leap Motion Controller; and the control group (CG), who will receive treatment with conventional physiotherapy.
- EVALUATION INSTRUMENTS: A participant identification form will be filled out, containing full name, date of birth, gender, address, telephone number, education, diagnosis, time of diagnosis, onset of symptoms (laterality), associated diseases, PD subtype and medicines. Individuals will be assessed for: the motor aspects of experiences and activities of daily living using the TEMPA test and the Unified Assessment Scale for Parkinson's Disease (MDS-UPDRS) part II; Motor Assessment and subtype of the disease, using the MDS-UPDRS scale III; motor staging of PD using the Hoehn \& Yahr scale; muscle strength and endurance, using the handgrip dynamometer (TEMPA test); manual dexterity, through the Box and Block test and the Nine Hole Peg test; cognitive issues through the Montreal Cognitive Assessment (MoCA); and quality of life, through the Questionnaire on Parkinson's Disease (PDQ-39).
- EXPECTED DURATION: The present research project contemplates different objectives, this being a study proposal to be developed during four years.
- PROCEDURES: The formation of each of the groups will be done through the generation of a random sequence through the tool available at http://www.randomize.com. Therefore, individuals will be divided into two groups: Intervention Group and Control Group. Subsequently, the initial assessment will be made,TEMPA, MDS-UPDRS-II e III, motor staging of the disease (H\&Y), Box and Block Test, Nine Hole Peg Test), MoCA and PDQ-39.The IG will carry out a 2-month intervention protocol, with 16 40-minute interventions, twice a week. The CG will perform a conventional physiotherapy protocol for the same period as the IG. Therefore, all groups will receive the same evaluation procedures that will be performed before the intervention (PRE), after the intervention (POST) and, finally, 30 days after the intervention (follow-up). The researchers responsible for the intervention will not be aware of the evaluations carried out and the evaluators will not be aware of the group to which the participant will belong. Both groups will be able to follow their routine activities (physical and / or physical therapy) and all procedures will be performed in the home environment of each research participant.
- ETHICAL AND LEGAL PROCEDURES The study project in question will be submitted to the Research Ethics Committee of the Federal University of Health Sciences of Porto Alegre (UFCSPA) and will only be applied after due approval. All participants will be informed about the procedures, objectives, justifications, potential risks and benefits of their participation in the study. The research will not present risks to the participant, but if there is any discomfort during any activity, the treatment will be stopped immediately and the necessary measures taken. In addition, all participants must sign the informed consent form and receive a copy of it. The use of any type of image will not identify the participant and will only be used with written consent. The data in the medical record (name, telephone and address) will be used for screening in the identification and contact of individuals and stored in a database that will be accessed only by researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed work will be characterized as a Randomized Clinical Trial, with evaluators outside the experimental groups (single-blind). The sample will be probabilistic, from individuals diagnosed with Parkinson's disease.
| Arm | Type | Receives |
|---|---|---|
| Leap Motion Controller | Experimental | Other: Leap Motion Controller, Other: Conventional PhysiotherapyIntervention Group: which will receive treatment with Leap Motion Controller |
| Conventional Physiotherapy | Active comparator | Other: Leap Motion Controller, Other: Conventional PhysiotherapyControl Group: who will receive treatment with conventional physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease diagnostic;
- Classified as I-III on the Hoehn \& Yahr motor staging scale;
- Are over 18 years old (above this, without age restriction).
- Residents in the city of Porto Alegre / RS.
- Have signed an informed consent form.
Key exclusion criteria (4 listed)
- Do not show the understanding of the games on the first day of familiarization;
- Have a cerebral pacemaker implant;
- Have recent injuries or limitations that make the MMSS impossible.
- Do not perform / abstain from two appointments out of the 16 proposed in the intervention protocol, regardless of the group that will be allocated.
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 |
|---|---|---|
| Leap Motion ControllerTraining with the Leap Motion Controller instrument will be carried out first for 5 minutes, for a presentation and interaction of the virtual immersion with it, in the initial meeting. After the second meeting, the attendance protocol will be 16 sessions, this time being distributed as: first game lasting 7 minutes, second and third games lasting 6 minutes each and the last game lasting 8 minutes, totaling 27 minutes of intervention. Between games it was adopted about 2 minutes of rest. | Other | Conventional Physiotherapy, Leap Motion Controller |
| Conventional PhysiotherapyThe conventional physiotherapy intervention will be based on the same activities developed (MMSS movements) of the IG: - First, attach pins with magnets with moving disc and after 1 minute and 25 seconds remove flower petals from inside a tube. The movements performed will be fine motricity, related to the tweezers handling (thumb and forefinger), alternating hands after 2 minutes and 30 minutes of play; - Hitting your hands on suddenly raised rulers, performing bilateral flexion / extension movements of the wrist simultaneously and alternating hands after 2 minutes and 30 minutes of play. | Other | Conventional Physiotherapy, Leap Motion Controller |
Primary outcome
Test TEMPA (Test d'Évaluation des Membres Supérieurs de Personnes Agées)
Time frame: Pre and Post Immediate intervention. 30 days after interventions.
It is an instrument that serves to assess the degree of disability of the MMSS. It presents a manual on how to manage it, the necessary measures to make the box and where to dispose of each specific material of the tasks. The materials required for administering the test are as follows: 100 gram coffee pot, 1000 milliliter water jar, coffee spoon, cup, water glass, medicine bottle and 10 placebo capsules, white envelopes, seal, pencil , card game, coins (R $ 1, R $ 0.25, R $ 0.50, R $ 0.10), small glass jar (7 cm (cm) in diameter and 5 cm in height), small objects (toothpick, nut, safety pin, 2.5 cm diameter button and nail), piece of non-slip material and sheets for recording scores (MICHAELSEN et al., 2008). The test consists of performing bilateral and unilateral tasks, of the upper limbs.
1 secondary outcome
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Pre and Post Immediate intervention. 30 days after interventions.
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 18 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy in people with Parkinson Disease and Upper Extremity Dysfunction, run by Federal University of Health Science of Porto Alegre 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 5 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: finished, as of the sponsor's last update on 18 Sep 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?
Test TEMPA (Test d'Évaluation des Membres Supérieurs de Personnes Agées) (time frame: Pre and Post Immediate intervention. 30 days after interventions.). 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 Sep 2023.