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

November 2, 2022 updated by: Helena Fernández-Lago, Universitat de Lleida

Evaluating the Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease: Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Lleida, Spain, 25006
        • Recruiting
        • Institut de Recerca Biomèdica de Lleida
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gamified virtual reality environtment + tDCS + treadmill gait training
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.
Other: Gamified virtual reality treadmill gait training with tDCS
Progressive treadmill gait training in a gamified virtual reality environment with tDCS
EXPERIMENTAL: Gamified virtual reality environtment + treadmill gait training
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.
Other: Gamified virtual reality treadmill gait training
Progressive treadmill gait training in a gamified virtual reality environment
ACTIVE_COMPARATOR: Treadmill gait training
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.
Other: Treadmill gait training
Progressive treadmill gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride lenght
Time Frame: 14 weeks
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters (m).
14 weeks
Speed
Time Frame: 14 weeks
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters per second (m/s).
14 weeks
Step cadence
Time Frame: 14 weeks
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in Hertz (Hz).
14 weeks
Stride Length during Dual Task
Time Frame: 14 weeks
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters (m).
14 weeks
Speed during Dual Task
Time Frame: 14 weeks
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters per second (m/s).
14 weeks
Step cadence during Dual Task
Time Frame: 14 weeks
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in Hertz (Hz).
14 weeks
Stride Length Variation Coeficient
Time Frame: 14 weeks
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following: (Standard deviation/mean Stride Length)100
14 weeks
Stride Length Variation Coeficient during Dual Task
Time Frame: 14 weeks
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Stride Length)100
14 weeks
Step Cadence Variation Coeficient
Time Frame: 14 weeks
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following: (Standard deviation/mean Step Cadence)100
14 weeks
Step Cadence Variation Coeficient during Dual Task
Time Frame: 14 weeks
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Step Cadence)100
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cognitive Performance
Time Frame: 14 weeks
A battery of executive function tests will be applied, which in combination will allow for a total cognitive performance calculation. The used tests to calculate the Total Cognitive Performance are: Trail Making Test, Digit Span Backwards, Word Fluency Phonemic and Semantic, Wisconsin Card Sorting Test, Corsi Block Test, and Tower of London Test. These test scores will be converted to z-test scores and integrated with a formula to obtain the Total Cognitive Performance score.
14 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: 14 weeks
The UPDRS is made up of 42 items grouped into four subscales: Section I-mentation, behavior and mood; Section II-activities of daily living (scored for "on" and "off"); Section III-motor exam; and Section IV-complications. Items from Sections I to III are scored on a 4-point scale. Section IV contains dichotomous items and items scored on a 4-point scale for duration or severity. Higher scores indicate more severe impairment.
14 weeks
Hoehn & Yahr
Time Frame: 14 weeks
Assess symptom progression in Parkinson's Disease based on a 5-stage scale, in which stage 1 is the most autonomous and stage 5 implies bedridden or wheelchair-bound patients unless assisted.
14 weeks
Parkinson's Disease Questionnaire 39
Time Frame: 14 weeks
Patient-reported 39 item questionnaire to assess Parkinson's Disease related quality of life and health status across 8 dimensions of daily living. Higher scores indicate worse quality of life.
14 weeks
MiniBest Test
Time Frame: 14 weeks
14-item test to assess dynamic balance. Lower scores mean a worse balance condition.
14 weeks
Montreal Cognitive Assessment
Time Frame: 14 weeks
30-question test to assess cognitive function. Lower scored mean a worse cognitive status.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Lleida

Collaborators

University of Maryland, Baltimore
University of Turku

Investigators

  • Principal Investigator: Helena Fernández-Lago, Universitat de Lleida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2023

Primary Completion (ANTICIPATED)

March 1, 2024

Study Completion (ANTICIPATED)

September 1, 2024

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (ACTUAL)

February 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI20/00403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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