Biofeedback Rehabilitation in Parkinson's Disease (GAMEPAD_PD)

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Gamepad system; Other: Conventional physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02713971

GR-2009-1604984-GAMEPAD

Details and patient eligibility

About

Background: In this study, a new biofeedback system for balance and gait rehabilitation (Gamepad) was developed. The system, based on wearable inertial sensors, provides users with real-time visual and acoustic feedback about their movement during functional tasks. Gamepad was applied on subjects with Parkinson's disease (PD) in a pilot randomized controlled trial to investigate its feasibility and efficacy versus conventional physiotherapy. The investigators hypothesized that Gamepad system can be easily applied in clinical settings and that biofeedback training with Gamepad provides larger improvements of balance and gait in PD subjects, respect to conventional physiotherapy.

Methods: Forty-two PD patients underwent a 20-session training for balance and gait (45 minutes per session, 3 sessions per week). Participants were randomized into Gamepad Group (biofeedback rehabilitation with Gamepad system), and Control Group (conventional physiotherapy). Clinical and instrumental assessments were performed by a blind examiner pre-, post-intervention and at 1-month follow-up.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hoehn-Yahr stage 2 to 4.
• Ability to stand up more than 10 s and inability to stand on one foot more than 10 s.
• Ability to walk for at least 6 m even with an assistive device.
• Stable drug usage.

Exclusion criteria

• Mini-Mental State Examination < 24.
• Implanted deep brain stimulator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

42 participants in 2 patient groups

Gamepad

Experimental group

Description:

Biofeedback rehabilitation with Gamepad system.

Treatment:

Device: Gamepad system

Control

Active Comparator group

Description:

Conventional physiotherapy.

Treatment:

Other: Conventional physiotherapy