Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment

Parkinson´s Disease Clinical Trial

Official title:

Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580787
• Other study ID #: saocamilo-sp
• Status: Completed
• Phase: N/A
• First received: April 16, 2012
• Last updated: April 18, 2012
• Start date: August 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Sao Camilo University Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinson´s disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one.

The study was finished at december 2011.

Description:

The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinson´s disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session was composed of a 30 minute-global-exercise series including stretching, muscle strengthen and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures were: (1) Unified Parkinson´s Disease Rating Scale (UPDRS); (2) Berg Balance Scale (BBS); (3) Unipedal Stance Test (UST) and (4) Montreal Cognitive Assessment (MoCA). The statistical analysis was done by repeated measures ANOVA in order to assess the possible differences among the analyzed variables. Both groups showed improvement in the section II of UPDRS, BBS, UST and MoCA. Patients with Parkinson´s disease showed balance and cognitive improvement with positive repercussion on daily living activities after 14 sessions of balance training without additional advantages to the virtual training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with Parkinson´s disease

• both gender

• on stages 1 and 2,5 of Hoehn e Yahr

Exclusion Criteria:

• depression

• cognitive impairment

• deficits of visual acuity

• Score on Berg Balance Scale under 46

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson´s Disease

Intervention

Device:
• Balance Training with Nintendo Wii Fit
The participants of the study trained 10 balance games during 14 sessions.

Other:
• Physical Therapy
Patients of the control group was trained with balance exercises.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sao Camilo University Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UNIFIED PARKINSON'S DISEASE RATING SCALE	The scale assesses the functional status of patients with parksinon´s disease, including the independency of daily activities, mood, secondary effects of medications and motor complications.	08/2011 (up to 2 years)
Secondary	Berg Balance Scale	Berg Balance Scale assesses the functional balance of patients with Parkinson´s disease. It is a clinic assessment of patient that evaluates the performance of patient to stand up and sit down, turn on and step, among others situations.	08/2011 (up to 2 years)