Clinical trial NCT02713971: Biofeedback Rehabilitation in Parkinson's Disease
Official title: Wearable Sensor-based Biofeedback Training for Balance and Gait in Parkinson's Disease: a Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Rehabilitation
Balance
Gait
Biofeedback
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-treatment score of Berg Balance Scale
timeFrame: 7 weeks
measure: Post-treatment score of 10-meter Walk Test
timeFrame: 7 weeks
Secondary outcomes:
measure: Follow-up score of Berg Balance Scale
timeFrame: 11 weeks
measure: Follow-up score of 10-meter Walk Test
timeFrame: 11 weeks
measure: Scores of Unified Parkinson's Disease Rating Scale - Motor examination (UPDRS-III)
timeFrame: 7 weeks and 11 weeks
measure: Scores of Timed Up and Go test
timeFrame: 7 weeks and 11 weeks
measure: Scores of Activities-specific Balance Confidence scale (ABC)
timeFrame: 7 weeks and 11 weeks
measure: Scores of Freezing Of Gait Questionnaire (FOGQ)
timeFrame: 7 weeks and 11 weeks
measure: Scores of Parkinson's Disease Questionnaire-39 (PDQ-39(
timeFrame: 7 weeks and 11 weeks
measure: Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)
timeFrame: 7 weeks
measure: Amplitude of body sway in antero-posterior (Sway AP) and medio-lateral (Sway ML) directions
timeFrame: 7 weeks and 11 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Gnocchi ONLUS
Study officials:
affiliation: Fondazione Don Gnocchi Onlus
name: Ilaria Carpinella, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowman T, Gervasoni E, Parelli R, Jonsdottir J, Ferrarin M, Cattaneo D, Carpinella I. Predictors of mobility domain of health-related quality of life after rehabilitation in Parkinson's disease: a pilot study. Arch Physiother. 2018 Dec 27;8:10. doi: 10.1186/s40945-018-0051-2. eCollection 2018.
citation: Carpinella I, Cattaneo D, Bonora G, Bowman T, Martina L, Montesano A, Ferrarin M. Wearable Sensor-Based Biofeedback Training for Balance and Gait in Parkinson Disease: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Apr;98(4):622-630.e3. doi: 10.1016/j.apmr.2016.11.003. Epub 2016 Dec 10.