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

NCT ID: NCT01580787

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-04-30

Brief 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.

Detailed 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.

Conditions

Parkinson´s Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Training

The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.

Group Type: EXPERIMENTAL

Balance Training with Nintendo Wii Fit

Intervention Type: DEVICE

The participants of the study trained 10 balance games during 14 sessions.

Physical Therapy

The Control Group was trained by conventional Physical Therapy exercises.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Patients of the control group was trained with balance exercises.

Interventions

Balance Training with Nintendo Wii Fit

The participants of the study trained 10 balance games during 14 sessions.

Intervention Type: DEVICE

Physical Therapy

Patients of the control group was trained with balance exercises.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sao Camilo University Center

OTHER

Sponsor Role: lead

Responsible Party

Jose Eduardo Pompeu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José E Pompeu, PhD

Role: PRINCIPAL_INVESTIGATOR

Sao Camilo University Center

References

Pompeu JE, Mendes FA, Silva KG, Lobo AM, Oliveira Tde P, Zomignani AP, Piemonte ME. Effect of Nintendo Wii-based motor and cognitive training on activities of daily living in patients with Parkinson's disease: a randomised clinical trial. Physiotherapy. 2012 Sep;98(3):196-204. doi: 10.1016/j.physio.2012.06.004. Epub 2012 Jul 25.

Reference Type: DERIVED

PMID: 22898575 (View on PubMed)

Other Identifiers

saocamilo-sp

Identifier Type: -

Identifier Source: org_study_id