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Effects of training with Immersive Virtual Games compared to Stationary Cycling on tremor, upper limb function and cognition in people with Parkinson's Disease: randomized clinical trial

Effects of Immersive Virtual Reality training compared with Stationary Cycling on tremor, upper limb function and cognition in people with Parkinson's Disease: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7h6b8mg
Enrollment
Unknown
Registered
2023-12-11
Start date
2023-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Interventions

Virtual Reality Exposure Therapy, Cycle Ergometer and Control Group. Virtual Reality Exposure Therapy, Stationary Cycling and Control Group. Patients who meet the inclusion criteria will be randomly a
E01.370.386.700.250
L01.224.160.875

Sponsors

Faculdade de Ceilândia da Universidade de Brasília
Lead Sponsor
Associação de Centro de Treinamento de Educação Física Especial
Collaborator

Eligibility

Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: Individuals of both genders; diagnosed with PD by a neurologist according to the MDS-PD criteria and selected by a physical therapist for study eligibility; classified in stages I to III according to the Hoehn & Yahr classification; age between 50 and 85 years; presence of classic parkinsonian tremor type 1, according to the consensus statement of the Movement Disorders Society; Minimum score on the Mini Mental State Examination according to schooling median scores; normal or corrected visual and hearing acuity; Minimum schooling of 4 years of formal study; normal or corrected visual and hearing acuity; a minimum of 4 years of formal schooling

Exclusion criteria

Exclusion criteria: Individuals with other associated neurological diseases or conditions that prevent participation in the training; have previous experience with the Quest 2® system; be attending another specialized rehabilitation program; have a score higher than 5 on the Geriatric Depression Scale - GDS - 15 items; have undergone implantation of deep brain stimulation electrodes; present visible dyskinesia in upper limbs

Design outcomes

Primary

MeasureTime frame
To assess Tremor in people with Parkinson's Disease using the following instruments: 1. Unified Parkinson's Disease Rating Scale (UPDRS) - This is a clinical scale that assesses the signs and symptoms of the disease, as well as functional activities, by means of a clinical assessment and interview. It consists of 65 items, divided into 4 domains. Parts II (Motor Aspects of Daily Life Experiences) and III (Motor Assessment) will be used to assess tremor. Part II will include item 2.10, which addresses the presence of tremor and its impact on the patient's daily life, and Part III will include items 3.15, 3.16, 3.17 and 3.18, which address postural tremor, kinetic tremor, tremor amplitude and tremor persistence, respectively. The items are rated from 0 (normal) to 4 (greatest impairment). 2) StudyMyTremor® smartphone application which provides the peak frequency (Hz), amplitude (mm) and power (mw per kg of the mass of the tested hand) of the tremor. The participant will hold the smartphone over the palm of each hand while the UPDRS scale items described above are applied. The peak frequency, amplitude and power of the tremor measured by the app during the application of the UPDRS will then be recorded. Thus, it is expected to find a reduction of at least 50% in tremor in participants who are part of the intervention groups compared to the control group, verified by the aforementioned instruments, since previous studies have verified a reduction in tremor of up to 50% from stationary cycling

Secondary

MeasureTime frame
To assess muscle architecture, a portable ultrasound machine (M-Turbo®, Sonosite, Bothwell, WA, USA) will be used in B-mode with a 7.5 MHz linear transducer and a depth of 6 cm. The biceps and triceps brachii, flexors and extensors of the fingers, radial and ulnar flexors of the carpus will be assessed according to the anatomical reference described by ABE et al. (2014), as adapted from BLAZEVICH et al. (2006). To measure muscle thickness, a line will be drawn in the thickest area of each muscle, between the superficial and deep aponeurosis. The pennation angle variable refers to the angulation of the fibers in relation to the muscle's line of force action. The length of the fascicle will be considered as the total length of the muscle fiber, however, as the fascicles are too long to be measured from the origin to the insertion, i.e. the distance between the aponeuroses and the myotendinous junctions, the estimated length has been obtained using the formula by BLAZEVICH et al. (2006). As for echogenicity, this will be done using gray scale analysis, in which the affected muscles appear whiter, i.e. hyperechogenic, as a result of an increase in intramuscular fibrous and fatty tissue and areas of necrosis. It is hoped to compare the data before and after the intervention for further analysis and verification of changes in the muscular structure of this population in a descriptive way, since there is no previous data in the literature according to research carried out by the authors.;To verify Upper Limb Functionality by means of the following instruments: 1. Nine hole peg test (9HPT) that requires participants to quickly pick up 9 small pins from a compartment, insert them into a target plate with nine holes until it is filled, one at a time unilaterally, and then remove them and put them back in the initial compartment, the outcome variable is the total time to complete the task. 2. Box and block test (BBT) that consists of a box, divided into two spaces by a panel,

Countries

Brazil

Contacts

Public ContactEllen Ferreira da Silva

Faculdade de Ceilândia da Universidade de Brasília

cep.fce@gmail.com+556131078434

Outcome results

None listed

Source: REBEC (via WHO ICTRP)