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

NCT04796246 | Completed

• 1 other identifier: 24443019.7.0000.5345
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Upper Extremity Dysfunction; Therapy-Related MDS

Keywords

Parkinson Disease; Upper Extremity Disfunction; Therapy-Related MDS

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre and Post Immediate intervention. 30 days after interventions.

Secondary Outcomes (1)

• Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  Pre and Post Immediate intervention. 30 days after interventions.

Other Outcomes (5)

• Hoehn & Yahr Scale

  Pre and Post Immediate intervention. 30 days after interventions.

• Box and Block Test

  Pre and Post Immediate intervention. 30 days after interventions.

• Nine Hole Peg Test

  Pre and Post Immediate intervention. 30 days after interventions.

Study Arms (2)

Leap Motion Controller

EXPERIMENTAL

Intervention Group: which will receive treatment with Leap Motion Controller

Other: Leap Motion Controller; Other: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Control Group: who will receive treatment with conventional physiotherapy.

Other: Leap Motion Controller; Other: Conventional Physiotherapy

Interventions

Leap Motion Controller OTHER

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 Physiotherapy; Leap Motion Controller

Conventional Physiotherapy OTHER

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.

Conventional Physiotherapy; Leap Motion Controller

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Philipe Souza Correa

Porto Alegre, Rio Grande do Sul, 55, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Ph.D, Fernanda Cechetti

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: March 12, 2021
• Study Start: January 15, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

BR (1)