A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson

NCT ID: NCT04117737

Last Updated: 2020-01-28

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2019-12-30

Brief Summary

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

The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.

Detailed Description

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

Conditions

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

Parkinson Disease Gait Disorders, Neurologic

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Outcomes assessor was blinded to outcomes values between sessions and to the adherence of participants to the intervention.

Study Groups

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

Intervention

Single-arm

Group Type EXPERIMENTAL

Virtual reality combined with anti-gravity treadmill

Intervention Type OTHER

The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.

The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.

Interventions

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

Virtual reality combined with anti-gravity treadmill

The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.

The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Having Parkinson's disease diagnosed by a neurological doctor.
* Having an alteration of the gait caused by the neurological disorder.
* Being able to have an independent and voluntary walk of 10 meters as minimum.
* Height more than 150 cm.

Exclusion Criteria

* Being blind.
* Medical contraindications for walking.
* Being amputee.
* Alcohol or drugs abuse.
* Other diseases that impedes the intervention.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad San Jorge

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pablo Herrero, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad San Jorge

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asociación de Parkinson de Aragón

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI18/386

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.