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Virtual games or stationary cycling

Researchers are comparing exercise approaches for tremor, arm function and thinking in Parkinson's.

Testing a treatment or activity · Study reference: RBR-7h6b8mg

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Results reported

Start (reported date)
2023-01-01
Study finished (reported date)
2024-06-30

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Are There Cognitive and Anxiety Improvements in People With Parkinson's Disease After Xbox Kinect Training Compared With No Intervention? A Non-Randomized Controlled Trial.
This paper mentions the study ID; the relationship needs review · 2026

Who can join?

Ages 50y to 85y · Ask the team who can join

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Sex eligibility reported by registry: -

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: 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
Full study name & original research details

Official study title

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

Short title used by the registry

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

Original description

Intervention: 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 assigned to three groups with an equal number of participants: a control group that will not receive a specific intervention (CG), and two other groups: an Immersive VR group with Oculus Quest 2 (QG) and a Stationary Cycling group (SCG). Randomization and allocation will be carried out using block randomization generated using software available on the website ""www.random.org"", with a block size of 4 or 6. This randomization will be carried out by a researcher not involved in the study procedures. This researcher will be instructed to keep the allocation in sealed, opaque envelopes, which will be opened individually only before the participant begins their training. A trained assessor will be blinded to the allocation of participants to the study groups. Only the physiotherapist responsible for conducting the training will be aware of how the participants were allocated. According to the sample size calculation, based on the study by Ridgel et al. (2015), there will be 36 participants distributed equally in the groups. Thus, the QG will have 12 participants, the SCG will have 12 participants and the CG will have 12 participants. The equipment selected for the virtual reality exposure therapy will be the Oculus Quest 2. This is a Head Mounted Display (HMD) that has an autonomous system and only needs 2 controls and a WIFI network to operate. It is a portable and more economical option than the most commonly used models, as it does not require a support computer to set up the gaming area. An analysis will be made of the most appropriate games for patients to use. Physiotherapi;E01.370.386.700.250;L01.224.160.875 Primary outcome: 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 outcome: 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, filled with 150 blocks. On a signal from the examiner, the patient will take one block at a time with the dominant hand, carry it to the partition and release it in the opposite compartment. A timer is stopped after 1 minute, the examiner counts the blocks before returning them to the original compartment, then the procedure is repeated with the opposite hand. The score is given by the number of blocks carried unilaterally from one compartment to the other in 1 minute. 3. upper extremity performance test for the elderly (TEMPA) which assesses unilateral, bilateral, and tasks that require shoulder and elbow movements along with hand movements. Each task is measured according to 3 criteria: duration of performance, functional classification, and task analysis. TEMPA is composed of 9 tasks representing daily activities, 5 of which are bilateral: 1) opening a jar and putting in a coffee spoon; 2) picking a lock and opening a pill container; 3) writing on an envelope and putting a stamp on it; 4) putting a handkerchief around your neck; 5) shuffling and dealing playing cards; and, 4 are unilateral; 1) picking up a jar and moving it; 2) picking up a jar and filling a glass; 3) handling coins; 4) picking up and moving small objects. It is expected that the mean scores of the participants will reach the minimum clinically important differences for each test;Assess cognition from the instruments: Trail Making Tests Parts A and B - Assess cognition through attention and working memory skills; REY's List - Assess memory; REY's Complex Figure: assesses visuospatial organization, planning and strategy development, and memory skills. It is expected that the mean scores of the participants will reach the minimum clinically important difference for each test;To evaluate the quality of life, the PDQ-39 questionnaire will be used, this assessment tool shows good content validity as a measure of health, functionality and well-being, besides being easily understood and contemplating important aspects of the disease, it has been indicated as the most appropriate instrument to assess the Quality of Life of patients with PD. The PDQ-39 is a specific scale for assessing the quality of life in PD and comprises 39 items that can be answered with five different response options: ""never""; ""once in a while""; ""sometimes""; ""often""; ""always"" or ""it is impossible for me"". The scores on each item range from 0 (never) to 4 (always or it is impossible for me). The PDQ-39 is divided into eight dimensions: Mobility (10 items); Activities of Daily Living (6 items), Emotional Well-Being (6 items), Stigma (4 items), Social Support (3 items), Cognition (4 items), Communication (3 items), and Body Discomfort (3 items). The total score for each individual is calculated according to the following formula: 100 x (sum of the patient's scores on the 39 questions / 4 x 39). The score for each dimension is obtained in the same way as the total score. The total score in the PDQ-39 ranges from 0 (no problem) to 100 (maximum problem level), i.e., a low score indicates better perception of quality of life (QoL) by the individual. The 39-item questionnaire developed has proven to be highly reliable both in terms of internal consistency and test-retest results. It is expected that the mean scores of the participants will reach the minimum clinically important differences for each test;To evaluate the torque during the maximum voluntary contraction (CVIM) the participants must remain seated comfortably and perform a warm-up consisting of 3 maximum contractions of 5s with a rest interval of 10s on a hand grip dynamometer (Grip Force Transducer, AD Instruments, Dunedin, New Zealand). Verbal instruction will be given to encourage them to exert maximum effort to grip the hand. It is expected that the mean scores of the participants will reach the minimum clinically important differences for each test;During the maximum force evaluation the surface electromyographic activity of the surface components of the biceps brachii, triceps brachii, brachioradialis, extensor and flexor digitorum longus, tensor and hypothenar eminence will be verified. The signal will be recorded bipolarly by means of four pairs of circular silver chloride (AgCL) electrodes, each measuring 20 mm in diameter and with a recording diameter of 10 mm and separated by an inter electrode distance. A portable surface electromyograph (Miotols, Porto Alegre, RS, Brazil; Octopus AMT-8, Bortec Biomedical Ltd, Calgary, AB, Canada) will be used to collect the electromyographic activity, with 14-bit resolution, <2LSB noise level and 110db common rejection. The electromyographic signals will be interfaced with the PowerLab 8/35 biological signal aggregator (AD Instruments, Dunedin, New Zealand) for further processing in LabChart Pro software (AD Instruments, Dunedin, New Zealand). The EMG signals will be amplified with a frequency bandwidth between 15 Hz and 5.0 kHz (90 dB; impedance = 100 MO, gain = 1000 to obtain the Root Mean Square (RMS) of the raw signal. It is hoped to compare the data before and after the intervention for later 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 recent research by the researchers ;To evaluate the H-reflex and M-wave (single and double stimulation) will be performed using a high voltage stimulator (Nicolet, Viking Quest EMG, Madison, USA) in order to determine: (1) the mechanical properties of the flexor muscles of the hand; and (2) central activation ratio (CAR), using the contraction interpolation technique (Duclay et al., 2015; Grosprêtre et al., 2017). The stimulation electrodes will be placed in the region of the medial epicondyle over the ulnar and median nerve (two self-adhesive 8 mm electrodes) and moved to the position that provides the greatest visible contraction of the entire wrist and finger flexor group. To determine the best representative curve of the H-reflex, M-wave and maximum stimulation intensity for each subject, a series of single square wave stimuli (duration 1 ms, maximum voltage 400 V) will be applied by progressively increasing the current until there is no further increase in the isometric evoked contraction response (mMAX). The contraction peak obtained will be taken as the maximum stimulation intensity. Paired stimuli (10 ms intervals between two 1 ms pulses) will be delivered under isometric conditions (Babault et al., 2003), such paired (double) pulses are delivered to the ulnar and median nerve before (double stimulus at rest), superimposed on a CVIM and after the CVIM (relaxation period). RAC will be quantified with the formula: RAC (%) = [maximum voluntary torque / (maximum voluntary torque 1 overlapping torque)] X 100, this methodology has been used for central fatigue assessment (Kent-braun, 1999; Pajoutan et al., 2017). The distributed stimulations in the resting muscles immediately after each CVIM are used to calculate the peak resting dual stimulus (i.e., the amplitude of the maximum dual stimulus)

Conditions reported: Parkinson Disease;C10.228.140.079.862

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
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 assigned to three groups with an equal number of participants: a control group that will not receive a specific intervention (CG), and two other groups: an Immersive VR group with Oculus Quest 2 (QG) and a Stationary Cycling group (SCG). Randomization and allocation will be carried out using block randomization generated using software available on the website ""www.random.org"", with a block size of 4 or 6. This randomization will be carried out by a researcher not involved in the study procedures. This researcher will be instructed to keep the allocation in sealed, opaque envelopes, which will be opened individually only before the participant begins their training. A trained assessor will be blinded to the allocation of participants to the study groups. Only the physiotherapist responsible for conducting the training will be aware of how the participants were allocated. According to the sample size calculation, based on the study by Ridgel et al. (2015), there will be 36 participants distributed equally in the groups. Thus, the QG will have 12 participants, the SCG will have 12 participants and the CG will have 12 participants. The equipment selected for the virtual reality exposure therapy will be the Oculus Quest 2. This is a Head Mounted Display (HMD) that has an autonomous system and only needs 2 controls and a WIFI network to operate. It is a portable and more economical option than the most commonly used models, as it does not require a support computer to set up the gaming area. An analysis will be made of the most appropriate games for patients to use. Physiotherapi;E01.370.386.700.250;L01.224.160.875
Phases
N/A
Sponsor
Faculdade de Ceilândia da Universidade de Brasília
Start date reported by registry
2023-01-01 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Ellen Ferreira da Silva · +556131078434 · cep.fce@gmail.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

Brazil

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.