NCT02713971

Biofeedback Rehabilitation in Parkinson's Disease

Wearable Sensor-based Biofeedback Training for Balance and Gait in Parkinson's Disease: a Pilot Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Gamepad system	Patients executed a set of tailored exercises including the control of weight-shift and body posture during static (e.g. upright sitting and standing), quasi-dynamic (e.g. sit-to-stand and gait initiation) and dynamic tasks (e.g. getting on a step, straight-line walking, walking with turns and over obstacles). Participants executed the tasks using Gamepad system which provided patients with visual and auditory feedback about their performances and assigned a score at the end of each exercise. The physiotherapist progressively adjusted training complexity by changing the reference values, including more difficult taks, changing the perceptive context, and/or including a dual-task.
OTHER	Conventional physiotherapy	A set of tailored exercises was defined by the clinical staff following current guidelines for physiotherapy in Parkinson's disease. In particular, stretching, joint mobilization, and balance and gait exercises were provided to participants, without any instrumentation producing biofeedback or external cues.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2016-03-21
• Last updated: 2016-03-21

Locations

1 site across 1 country: Italy