Skip to main content
OpenTrials
Completed

NCT Number: NCT02680522

Safety Study to Autonomic Rehabilitation o Parkinson's Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade da Amazônia

Belém, Pará, 66060902, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

exercise training with virtual reality in videogame

Primary outcomes

  1. Heart Rate Variability

    Time frame: evaluation before the beginning of the rehabilitation protocol and after 24 sessions (3 months)

    Data collection 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.

    For the analysis we used the Kubius HRV Analysis Version 2.0 software (Kuopio, Finland). 50 volunteers evaluation with Parkinson's disease and 50 healthy volunteers to investigate the improvement of autonomic modulation. all volunteers will be evaluated after three months of the end of the rehabilitation protocol in order to investigate whether the protocol improved the autonomic modulation in patients with Parkinson 's disease .

Sponsors and collaborators

Lead sponsor

Universidade Metodista de Piracicaba

Other

Registry information

Official study title

Study of Modulation Autonomic Heart Rate of Individuals With Parkinson's Disease and Healty Individuals Subject to a Training With Virtual Reality

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2016
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.