- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03235284
Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease
Efficacy of Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bahia
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Salvador, Bahia, Brazil, 40.110-060
- Complex Hospital Professor Edgard Santos, Federal University of Bahia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 40 and 80 years,
- Stage 1 to 3 on the Hoehn and Yahr scale,
- Absence of visual or auditory impairment,
Exclusion Criteria:
- Presence of cognitive alterations according to MEEM: illiterate 19 points; 1 to 3 years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points
- Presence of other neurodegenerative diseases,
- Uncontrolled osteomioarticular or chronic diseases
- Participation in other rehabilitation programs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercises
A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All
treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.
The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;
|
A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All
treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.
The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training
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Active Comparator: Nintendo Wii
Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game |
Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game |
Experimental: Exercises and Nintendo Wii
In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols
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In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale
Time Frame: 8 weeks
|
It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score. It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100% |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic Gait Index - DGI
Time Frame: 8 weeks
|
It is a scale that allows a functional assessment of the balance of the performance.
Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs .
The maximum score is 24 points, and a score of 19 points or less predicts risk of falls.
The scale has no gaps, only cutoff points.
The higher the value, the better the gait performance.
For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.
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8 weeks
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Timed Up and Go - TUG
Time Frame: 8 weeks
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The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again. The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed. TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility |
8 weeks
|
Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: 8 weeks
|
39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's. It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life. |
8 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NintendoWii x Exercises
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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