NCT05922046Completed
Age Dependents Benefits of Virtual Reality Rehabilitation
Age Dependents Benefits of Virtual Reality Rehabilitation: Single Blind Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Nov 2024
Brief summary (registry, in English)
ntroduction: Parkinson\'s disease (PD) is characterized as a neurodegenerative disorder associated with progressive loss of dopamine in the basal ganglia region, resulting in classic motor symptoms such as bradykinesia, rigidity, postural instability and tremor. Such symptoms end up affecting the functionality of the upper limbs (MMS) in this population. In recent years, Virtual Reality (VR)-based therapy has been gaining popularity, but studies in the area are still lacking. Objective: To verify the benefits of virtual reality in individuals with PD above 65 years of age and in individuals below 65 years of age in the functionality of the upper limbs and to identify possible differences between them. Methodology: This is a randomized clinical trial, in which the evaluators will be separated into two experimental groups. Subjects with PD will be randomized into two groups: Group 65 years or over (GI1), and Group below 65 years of age (GI2). Both will receive treatment with virtual reality games in a non-immersive environment (flat screen) through the Leap Motion Controller (LMC) device. Both treatments will focus on large and fine upper limb tasks, in a protocol with 4 activities and duration of approximately 27 minutes, twice a week, for eight weeks. The two groups will be evaluated in three moments: before the intervention and immediately after 8 weeks. They will be analyzed manual dexterity through the Box and Block test and the Nine Hole Peg Test, Activities of Daily Living level through the TEMPA test and part II of the unified PD assessment (MDS-UPDRS II); motor assessment (part III) of the MDS-UPDRS ; cognition by Montreal Cognitive Assessment (MoCA); quality of life through the PD questionnaire (PDQ-39);. It is expected that this study will show that the treatment applied to the younger population presents better results when applied to the older population.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 8 Jun 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 22 Apr 2024
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Diseases
- Parkinson disease
- NCT number
- NCT05922046
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 1 Mar 2024 to the primary completion date, 22 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a cerebral pacemaker implant;
Other
- Do not show the understanding of the games on the first day of familiarization;
- 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.
Who the study is looking for
- 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.
- To identify subjects with manual dexterity deficits, a cut-off score of 21.1 seconds for the dominant limb and 22.3 seconds for the non-dominant limb was used for male subjects, and 19.9 seconds for the dominant limb and 21.4 seconds for the non-dominant limb was used for female subjects on the Nine-Hole Peg Test (9HPT)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidade Federal de Ciências da Saúde de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.