Leap Motion Controller on the Functionality of Upper Limbs in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease; Upper Extremity Dysfunction; Therapy-Related MDS
• Interventions: Other: Leap Motion Controller; Other: Conventional Physiotherapy

• Registration Number: NCT04796246
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Study Start: 2022-01-15
• Primary Completion: 2022-06-01
• Study Completion: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Leap Motion Controller	Leap Motion Controller	Intervention Group: which will receive treatment with Leap Motion Controller
Leap Motion Controller	Conventional Physiotherapy	Intervention Group: which will receive treatment with Leap Motion Controller
Conventional Physiotherapy	Leap Motion Controller	Control Group: who will receive treatment with conventional physiotherapy.
Conventional Physiotherapy	Conventional Physiotherapy	Control Group: who will receive treatment with conventional physiotherapy.

Primary Outcome Measures

Name	Time	Method
Test TEMPA (Test d'Évaluation des Membres Supérieurs de Personnes Agées)	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.

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Pre and Post Immediate intervention. 30 days after interventions.	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.

Trial Locations

Locations (1)

Philipe Souza Correa; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil