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The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Virtual Reality with Manual and Verbal Guidance
Virtual Reality with No Manual and Verbal Guidance
Physical Therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Virtual Reality, International Classification of Functioning, Disability and Health, Rehabilitation, Gait, Balance

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
  • Active treatment with levodopa
  • Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification

Exclusion Criteria:

  • Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
  • Severe respiratory and / or cardiovascular conditions
  • Visual and / or auditory deficit that can not be corrected with orthotics;
  • Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance;
  • Previous experience with Microsoft XBOX Kinect® games;
  • Be in rehab at another location concomitant with study training.

Sites / Locations

  • Brazil Parkinson Association
  • Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Manual and verbal guidance (MVG)

No manual and verbal guidance (NMVG)

Physical Therapy

Arm Description

The MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system®

The NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern.

The Control Group will be trained by conventional Physical Therapy exercises.

Outcomes

Primary Outcome Measures

Change in Functional balance and gait with Best Test
A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability
Change in Gait with 6 minut walk test
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
Change in Functional balance with Rapid turn test
Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left).

Secondary Outcome Measures

Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale
It's a scale composed of four parts: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications)
Risk of falls with FES-I scale
presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry)
Endurance with 6 minut walk test
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions

Full Information

First Posted
September 5, 2018
Last Updated
February 14, 2019
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03774225
Brief Title
The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease
Official Title
Effects Of Physiotherapy Intervention In A Motor Training With Virtual Reality On Motor, Cognitive, Balance And Gait Of Patients With Parkinson Disease: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
July 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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

5. Study Description

Brief Summary
A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo, Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in two groups: Experimental Group (EG), that performed the balance and gait training based on games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance (MVG) provided by a PT and a control group (CG) that performed an identical training with no MVG during the training.
Detailed Description
It were recruited PPD in the "Brazil Parkinson Association" (BPA), a no-government association of PD care, where the assessments and intervention were performed from December 2017 to June 2018. The PPD were recruited by randomization from the BPA list of active patients and waiting list for PT intervention. Outcome measures were obtained at up to three time points: before intervention, after 1 week and after 8 weeks of the end of intervention, the last time point was considered as a follow-up assessment. This study is in agreement with CONSORT guidelines for developing randomised trials . Primary measures was the functional balance evaluation by the Balance Evaluation Systems Test (BESTest) and Rapid Turn Test (RT Test), and gait performance assessed in the six-minute walk test and Gait test in 30 seconds. As secondary measures were used: Unified Parkinson's Disease Rate Scale (UPDRS), 5-Step Standing Passing Test (ST-DP5), International Falls Efficiency Scale (FES-I), Brazilian Version of the Freezing Scale March (FOGQ), Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Geriatric Depression Scale (GDS-15). All patients performed 8 individual training sessions, under the supervision of a physiotherapist, twice a week for four weeks. Each session had 10 minutes of identical global exercises for both groups, consisting of stretching, muscle strengthening and axial mobility exercises, one serie per session. After these initial 10 minutes, both groups performed an additional 40 minutes of balance training using four XBOX games, four per session, under different conditions for MVG and NMVG. While the Control Group will be trained by conventional Physical Therapy exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Virtual Reality, International Classification of Functioning, Disability and Health, Rehabilitation, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-blind, parallel-group, randomised trial
Masking
Investigator
Masking Description
The assessments where conducting by a blind examiner (investigator) in different days of the training. The examinator wasn't know which group the participant would be performing
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual and verbal guidance (MVG)
Arm Type
Experimental
Arm Description
The MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system®
Arm Title
No manual and verbal guidance (NMVG)
Arm Type
Experimental
Arm Description
The NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
The Control Group will be trained by conventional Physical Therapy exercises.
Intervention Type
Other
Intervention Name(s)
Virtual Reality with Manual and Verbal Guidance
Other Intervention Name(s)
Experimental Group with Manual and Verbal Guidance (MVG)
Intervention Description
Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.
Intervention Type
Other
Intervention Name(s)
Virtual Reality with No Manual and Verbal Guidance
Other Intervention Name(s)
Experimental Group with No Manual and Verbal Guidance (NMVG)
Intervention Description
Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Control Group
Intervention Description
Patients of the control group will be trained with balance exercises by a experient physiotherapist.
Primary Outcome Measure Information:
Title
Change in Functional balance and gait with Best Test
Description
A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability
Time Frame
1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Title
Change in Gait with 6 minut walk test
Description
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
Time Frame
1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Title
Change in Functional balance with Rapid turn test
Description
Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left).
Time Frame
1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Secondary Outcome Measure Information:
Title
Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale
Description
It's a scale composed of four parts: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications)
Time Frame
1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Title
Risk of falls with FES-I scale
Description
presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry)
Time Frame
1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
Title
Endurance with 6 minut walk test
Description
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
Time Frame
1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria Active treatment with levodopa Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification Exclusion Criteria: Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment Severe respiratory and / or cardiovascular conditions Visual and / or auditory deficit that can not be corrected with orthotics; Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance; Previous experience with Microsoft XBOX Kinect® games; Be in rehab at another location concomitant with study training.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisa P Piemonte
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazil Parkinson Association
City
São Paulo
ZIP/Postal Code
04142-092
Country
Brazil
Facility Name
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

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The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease

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