Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease

Universitat de Lleida

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: Treadmill gait training; Other: Gamified virtual reality treadmill gait training with tDCS; Other: Gamified virtual reality treadmill gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT05243394

PI20/00403

Details and patient eligibility

About

The study aims to compare the effects of treadmill gait training in a gamified virtual reality environment with tDCS versus treadmill gait training in a gamified virtual reality environment versus treadmill training in people with Parkinson's Disease.

Full description

Treadmill gait training has been stablished as a solid gait rehabilitation option for people with Parkinson's Disease. However, gait training by itself fails to address the cognitive aspect needed for safe walking, which could be affected by situations in which concurrent tasks must be managed simultaneously to gait. It also lacks motivational aspects key to keep people with Parkinson's Disease adhered to treatment. Virtual reality and gamification are posed as useful tools to address both these issues, turning training into a more engaging activity and allowing complicated gait situations to be trained in a safe environment. Transcranial direct current stimulation (tDCS) could be combined with these mentioned treatment options, which could reinforce the learning of motor and cognitive skills during training.

The aim of this study is to evaluate the effects of the inclusion of a gamified virtual reality environment to a treadmill gait training program with tDCS in PD compared to the same training protocol with virtual reality and without it

Enrollment: 66 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Parkinson's Disease
• Stage II - III in the Hoehn and Yahr Scale during ON state
• Ability to walk for 10 minutes independently without stop

Exclusion criteria

• Significant cognitive decline based on mini mental status examination (MMSE <23)
• Severe auditory or visual deficits
• Other neurological/psychiatric conditions
• Any kind of cardiovascular complications that contraindicates physical activity
• Clinical history of any brain surgery or deep brain stimulation device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups

Gamified virtual reality environtment + tDCS + treadmill gait training

Experimental group

Description:

The first group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. They will be immersed in a gamified virtual reality environment in which they will interact with the in-game ambient by having their feet represented on the screen and move as their own on the treadmill. They will also receive tDCS for the first 20 minutes of each session.

Treatment:

Other: Gamified virtual reality treadmill gait training with tDCS

Gamified virtual reality environtment + treadmill gait training

Experimental group

Description:

The second group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last. They will be immersed in a gamified virtual reality environment in which they will interact with the in-game ambient by having their feet represented on the screen and move as their own on the treadmill.

Treatment:

Other: Gamified virtual reality treadmill gait training

Treadmill gait training

Active Comparator group

Description:

The third group will follow an 18-session gait training protocol for 6 weeks. Duration of the sessions will progressively increase from 20 to 45 minutes from first session to last.

Treatment:

Other: Treadmill gait training