Safety Study to Autonomic Rehabilitation o Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Introduction: The Parkinson is one of the most common degenerative diseases of the central nervous system , mainly characterized by resting tremor , rigidity, akinesia and postural instability , also featuring the autonomic modulation of heart rate , which can lead to reduced frequency variability heart . Some activities may modify the modulation , including rehabilitation using virtual reality. Method: The research is interventional type , quantity and prospective, where volunteers were chosen for inclusion and exclusion criteria and divided into two groups , Control and Parkinson's, where they underwent 24 sections with virtual reality physiotherapy three times a week . Analysis of the autonomic modulation of heart rate was performed before and after the rehabilitation program with the frequency meter Polar brand. Statistical analysis was performed in 5.2 Biostat program with Shapiro- Wilk test to verify the normality , followed by t test to compare the data.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Virtual Exercises in Patients With Parkinson's Disease.

NCT02023034

Parkinson Disease

COMPLETED NA

Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease

NCT04876352

Parkinson Disease

COMPLETED NA

Age Dependents Benefits of Virtual Reality Rehabilitation

NCT05922046

Parkinson Disease

COMPLETED NA

Virtual Reality in Parkinson Disease

NCT02807740

Parkinson Disease

COMPLETED NA

Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease

NCT02516644

Parkinson Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To verify that the baseline conditions were adequate for the start of the collection, the volunteer remained 15 minutes at rest in supine position . They were measured and recorded : blood pressure by auscultation , using a mercury sphygmomanometer and a stethoscope ; and heart rate at rest by a heart rate monitor , with all measures carried out by the same researcher . Then the volunteer remained in the same position and was initiated to collect data with the registration of iR -R by Polar heart rate monitor model RS800CX (Polar Electro Co.Ltda . Kempele , Finland ) for 15 min. During the registration time, the participants maintained spontaneous respiration , were told not to talk , not sleep and avoid sudden movements . Subsequently , the recorded iR - R were transferred via an interface to a computer compatible for Polar softwere , the data being further processed into .txt format.

For the analysis we used the Kubius HRV Analysis Version 2.0 software (Kuopio, Finland). From the choice of the most stable stretch of five minutes, HRV was analyzed in the time domain (TD) and the variables selected the RR interval, the square root square mean difference between normal adjacent iR-R expressed in milliseconds (RMSSD) and SDNN, in the frequency domain via LF, HF and LF / HF addition to the non-linear analysis with the contents SD1, SD2 and Shannon Entropy.

To carry out the treatment with virtual reality Xbox 360® video game was the (Microsoft) used, the KinectTM Sensor, the kinectTM Adventures !, games with 6 modes and different phases and kinectTM Sports: Ultimate collection with 8 sports and different phases and TV Philips® the mark of 42 inches. The selected games were only the balance category, attention and planning, which consists of ten games, but only eight were used, including Kinect Sports game - "Tennis", "golf", "Ski" and the Kinect Adventure - "space bubble", "rapids", "top of the reflexes," "Hall of ricochets" and "leaks".

Before the first virtual training session , the presentation of the goals of each of the games and an adaptation session was held , where the therapists were next to the volunteer performing verbal commands . During the Games volunteers remained in the standing position and barefoot .

The volunteers performed 24 sessions in pairs, supervised by researchers for three times a week , every other day , lasting an hour each session. The scheduling range of care was organized so that the GP volunteers were always trained in the ON period of medication.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

composed of healthy volunteers who underwent training with virtual reality. Exercises with game through virtual reality

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

exercise training with virtual reality in videogame

Parkinson's Group

composed of patients with Parkinson's disease and who underwent training with virtual reality. exercises with game through virtual reality

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

exercise training with virtual reality in videogame

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

exercise training with virtual reality in videogame

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* clinical diagnosis of Parkinson's Disease confirmed by medical evidence
* disease progression between three and ten years
* ranked between levels 2-3 in the modified Hoehn and Yahr
* with higher scores 24 or classified as illiterate score for the Mini-Mental State Examination.

Exclusion Criteria

* With breathing problems induced by exercise
* orthopedic diseases
* with visual and / or hearing impairment
* uncontrolled hypertension
* use of vasoactive drugs
* which have performed heart surgery

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes