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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Virtual Reality with Manual and Verbal Guidance
* Other: Virtual Reality with No Manual and Verbal Guidance
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-blind, parallel-group, randomised trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual and verbal guidance (MVG)<br>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® | Other: Virtual Reality with Manual and Verbal Guidance<br>* Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.<br>* Other names: Experimental Group with Manual and Verbal Guidance (MVG);Other: Virtual Reality with No Manual and Verbal Guidance<br>* 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.<br>* Other names: Experimental Group with No Manual and Verbal Guidance (NMVG);Other: Physical Therapy<br>* Patients of the control group will be trained with balance exercises by a experient physiotherapist.<br>* Other names: Control Group;|
| Experimental: No manual and verbal guidance (NMVG)<br>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. | Other: Virtual Reality with Manual and Verbal Guidance<br>* Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.<br>* Other names: Experimental Group with Manual and Verbal Guidance (MVG);Other: Virtual Reality with No Manual and Verbal Guidance<br>* 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.<br>* Other names: Experimental Group with No Manual and Verbal Guidance (NMVG);Other: Physical Therapy<br>* Patients of the control group will be trained with balance exercises by a experient physiotherapist.<br>* Other names: Control Group;|
| Active Comparator: Physical Therapy<br>The Control Group will be trained by conventional Physical Therapy exercises. | Other: Virtual Reality with Manual and Verbal Guidance<br>* Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.<br>* Other names: Experimental Group with Manual and Verbal Guidance (MVG);Other: Virtual Reality with No Manual and Verbal Guidance<br>* 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.<br>* Other names: Experimental Group with No Manual and Verbal Guidance (NMVG);Other: Physical Therapy<br>* Patients of the control group will be trained with balance exercises by a experient physiotherapist.<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 
| 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 | 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) | 
| 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). | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 
| 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) | 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) | 
| Endurance with 6 minut walk test | a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, International Classification of Functioning, Disability and Health, Rehabilitation, Gait, Balance