Back to resultsNintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercises
Nintendo Wii
Exercises and Nintendo Wii
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease ande Video Games
Eligibility Criteria
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.
Sites / Locations
- Complex Hospital Professor Edgard Santos, Federal University of Bahia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Exercises
Nintendo Wii
Exercises and Nintendo Wii
Arm Description
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;
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
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
Outcomes
Primary Outcome Measures
Berg Balance Scale
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%
Secondary Outcome Measures
Dynamic Gait Index - DGI
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.
Timed Up and Go - TUG
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
Parkinson's Disease Questionnaire (PDQ-39)
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.
Full Information
NCT ID
NCT03235284
First Posted
July 27, 2017
Last Updated
September 11, 2019
Sponsor
Federal University of Bahia
1. Study Identification
Unique Protocol Identification Number
NCT03235284
Brief Title
Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease
Official Title
Efficacy of Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo Wii alone or together. After this period the patients will be reassessed to verify the effects of the techniques.
Detailed Description
Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Equilibrium Scale, Evaluated by the Dynamic Gait Index and the Timed up and go and PDQ-39. Later patients will be randomized to receive 16 sessions of Kinesiotherapy or Nintendo Wii alone or together, twice a week, for 50 minutes at the Neurociencias Outpatient Clinic of Teacher Magalhães Neto - FUBA. After this period the patients will be reassessed to verify the effects of the techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease ande Video Games
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single Blind (Outcomes Assessor)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercises
Arm Type
Active Comparator
Arm Description
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;
Arm Title
Nintendo Wii
Arm Type
Active Comparator
Arm Description
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
Arm Title
Exercises and Nintendo Wii
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Nintendo Wii
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Exercises and Nintendo Wii
Intervention Description
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
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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%
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dynamic Gait Index - DGI
Description
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.
Time Frame
8 weeks
Title
Timed Up and Go - TUG
Description
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
Time Frame
8 weeks
Title
Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Complex Hospital Professor Edgard Santos, Federal University of Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40.110-060
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://dx.doi.org/10.4236/apd.2013.24018
Description
Related Info
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Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease
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