Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Efficacy of Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235284
• Other study ID #: NintendoWii x Exercises
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2019
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• 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
• 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
• 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

Locations

Country	Name	City	State
Brazil	Complex Hospital Professor Edgard Santos, Federal University of Bahia	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	8 weeks
Secondary	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.	8 weeks
Secondary	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	8 weeks
Secondary	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.	8 weeks

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