Clinical trial NCT04796246: Leap Motion Controller on the Functionality of Upper Limbs in Parkinson's Disease
Official title: Leap Motion Controller on the Functionality Of Upper Limbs in Parkinson's Disease: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Upper Extremity Dysfunction
Therapy-Related MDS
Keywords: Parkinson Disease
Upper Extremity Disfunction
Therapy-Related MDS
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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

1. 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.
2. TYPE OF STUDY: Randomized Clinical Trial.
3. AREA OF SCOPE: Major area: Health Sciences. Area: Physiotherapy and Occupational Therapy.
4. LOCATION: The place where the entire study will be carried out will be in the home environment of each research participant.
5. 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.
6. 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).
7. EXPECTED DURATION: The present research project contemplates different objectives, this being a study proposal to be developed during four years.
8. 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.
9. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Test TEMPA (Test d'Évaluation des Membres Supérieurs de Personnes Agées)
timeFrame: Pre and Post Immediate intervention. 30 days after interventions.
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Pre and Post Immediate intervention. 30 days after interventions.
Other outcomes:
measure: Hoehn & Yahr Scale
timeFrame: Pre and Post Immediate intervention. 30 days after interventions.
measure: Box and Block Test
timeFrame: Pre and Post Immediate intervention. 30 days after interventions.
measure: Nine Hole Peg Test
timeFrame: Pre and Post Immediate intervention. 30 days after interventions.
measure: Montreal Cognitive Assessement - MoCA
timeFrame: Pre and Post Immediate intervention. 30 days after interventions.
measure: Parkinson's Disease Questionnaire - PDQ-39
timeFrame: Pre and Post Immediate intervention. 30 days after interventions.
Locations:
city: Porto Alegre
country: Brazil
facility: Philipe Souza Correa
state: RIO Grande DO SUL
Study officials:
References: