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

NCT04117737 | Completed

• 1 other identifier: PI18/386
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

Parkinson; Virtual reality; Anti-gravity treadmill; Rehabilitation; Gait disorders

Outcome Measures

Primary Outcomes (1)

• Changes in gait autonomy

  Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface.

  Baseline and 4-weeks

Secondary Outcomes (3)

• Changes in gait speed

  Baseline and 4-weeks

• Changes in balance and gait ability

  Baseline and 4-weeks

• Changes in quality of life

  Baseline and 4-weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Single-arm

Other: Virtual reality combined with anti-gravity treadmill

Interventions

Virtual reality combined with anti-gravity treadmill 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Being blind.
• Medical contraindications for walking.
• Being amputee.
• Alcohol or drugs abuse.
• Other diseases that impedes the intervention.

Sponsors & Collaborators

• Universidad San Jorge: lead

Study Sites (1)

Asociación de Parkinson de Aragón

Zaragoza, 50015, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pablo Herrero, PhD

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assessor was blinded to outcomes values between sessions and to the adherence of participants to the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: September 30, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 28, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)