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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gamified virtual reality treadmill gait training with tDCS
Gamified virtual reality treadmill gait training
Treadmill gait training
Sponsored by
Universitat de Lleida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Virtual Reality, Gamification, tDCS, Treadmill gait training, Dual Task

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut de Recerca Biomèdica de LleidaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Gamified virtual reality environtment + tDCS + treadmill gait training

Gamified virtual reality environtment + treadmill gait training

Treadmill gait training

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Stride lenght
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).
Speed
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).
Step cadence
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).
Stride Length during Dual Task
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).
Speed during Dual Task
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).
Step cadence during Dual Task
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).
Stride Length Variation Coeficient
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
Stride Length Variation Coeficient during Dual Task
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
Step Cadence Variation Coeficient
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
Step Cadence Variation Coeficient during Dual Task
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

Secondary Outcome Measures

Total Cognitive Performance
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.
Unified Parkinson's Disease Rating Scale (UPDRS)
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.
Hoehn & Yahr
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.
Parkinson's Disease Questionnaire 39
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.
MiniBest Test
14-item test to assess dynamic balance. Lower scores mean a worse balance condition.
Montreal Cognitive Assessment
30-question test to assess cognitive function. Lower scored mean a worse cognitive status.

Full Information

First Posted
January 20, 2022
Last Updated
November 2, 2022
Sponsor
Universitat de Lleida
Collaborators
University of Turku, University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05243394
Brief Title
Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease
Official Title
Evaluating the Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat de Lleida
Collaborators
University of Turku, University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Virtual Reality, Gamification, tDCS, Treadmill gait training, Dual Task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 groups of 22 participants will each follow a different treatment option.
Masking
Outcomes Assessor
Masking Description
The outcome measuring assessors will not know from which group any of the participants comes from, and will have no interaction with any of the interventions applied.
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gamified virtual reality environtment + tDCS + treadmill gait training
Arm Type
Experimental
Arm 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.
Arm Title
Gamified virtual reality environtment + treadmill gait training
Arm Type
Experimental
Arm 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.
Arm Title
Treadmill gait training
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Gamified virtual reality treadmill gait training with tDCS
Intervention Description
Progressive treadmill gait training in a gamified virtual reality environment with tDCS
Intervention Type
Other
Intervention Name(s)
Gamified virtual reality treadmill gait training
Intervention Description
Progressive treadmill gait training in a gamified virtual reality environment
Intervention Type
Other
Intervention Name(s)
Treadmill gait training
Intervention Description
Progressive treadmill gait training
Primary Outcome Measure Information:
Title
Stride lenght
Description
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).
Time Frame
14 weeks
Title
Speed
Description
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).
Time Frame
14 weeks
Title
Step cadence
Description
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).
Time Frame
14 weeks
Title
Stride Length during Dual Task
Description
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).
Time Frame
14 weeks
Title
Speed during Dual Task
Description
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).
Time Frame
14 weeks
Title
Step cadence during Dual Task
Description
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).
Time Frame
14 weeks
Title
Stride Length Variation Coeficient
Description
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
Time Frame
14 weeks
Title
Stride Length Variation Coeficient during Dual Task
Description
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
Time Frame
14 weeks
Title
Step Cadence Variation Coeficient
Description
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
Time Frame
14 weeks
Title
Step Cadence Variation Coeficient during Dual Task
Description
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
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Total Cognitive Performance
Description
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.
Time Frame
14 weeks
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
14 weeks
Title
Hoehn & Yahr
Description
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.
Time Frame
14 weeks
Title
Parkinson's Disease Questionnaire 39
Description
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.
Time Frame
14 weeks
Title
MiniBest Test
Description
14-item test to assess dynamic balance. Lower scores mean a worse balance condition.
Time Frame
14 weeks
Title
Montreal Cognitive Assessment
Description
30-question test to assess cognitive function. Lower scored mean a worse cognitive status.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Fernández-Lago
Phone
973702282
Email
helena.fernandez@udl.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Bosch-Barceló
Phone
645091315
Email
pere.bosch@udl.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Fernández-Lago
Organizational Affiliation
Universitat de Lleida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Recerca Biomèdica de Lleida
City
Lleida
ZIP/Postal Code
25006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Fernández-Lago
Phone
973702282
Email
helena.fernandez@udl.cat
First Name & Middle Initial & Last Name & Degree
Pere Bosch-Barceló
Phone
645091315
Email
pere.bosch@udl.cat

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18058946
Citation
Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.
Results Reference
background
PubMed Identifier
18808920
Citation
Shahed J, Jankovic J. Motor symptoms in Parkinson's disease. Handb Clin Neurol. 2007;83:329-42. doi: 10.1016/S0072-9752(07)83013-2. No abstract available.
Results Reference
background
PubMed Identifier
26940123
Citation
Mehrholz J, Kugler J, Storch A, Pohl M, Hirsch K, Elsner B. Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Oct;52(5):704-713. Epub 2016 Mar 4.
Results Reference
background
PubMed Identifier
28000926
Citation
Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.
Results Reference
background
PubMed Identifier
32925106
Citation
Schootemeijer S, van der Kolk NM, Ellis T, Mirelman A, Nieuwboer A, Nieuwhof F, Schwarzschild MA, de Vries NM, Bloem BR. Barriers and Motivators to Engage in Exercise for Persons with Parkinson's Disease. J Parkinsons Dis. 2020;10(4):1293-1299. doi: 10.3233/JPD-202247.
Results Reference
background
PubMed Identifier
26297812
Citation
Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20.
Results Reference
background
PubMed Identifier
23388087
Citation
Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, Dockx K, Nieuwboer A, Hausdorff JM. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013 Feb 6;13:15. doi: 10.1186/1471-2377-13-15.
Results Reference
background

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

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