Biofeedback Rehabilitation in Parkinson's Disease

NCT02713971 | Completed

• 1 other identifier: GR-2009-1604984-GAMEPAD
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Rehabilitation; Balance; Gait; Biofeedback

Outcome Measures

Primary Outcomes (2)

• Post-treatment score of Berg Balance Scale

  Score of Berg Balance Scale assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure. Berg Balance Scale rates balance from 0 (cannot perform) to 4 (normal performance) on 14 items exploring the ability to sit, stand, lean, turn and maintain the upright position on one leg. Maximum score (i.e. 56 points) indicates unimpaired balance.

  7 weeks

• Post-treatment score of 10-meter Walk Test

  Score of 10-meter Walk Test assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure. 10-meter Walk Test measures, with a stopwatch, the time (T) taken by the subject to walk between two lines at the distance of 10 meters. Walking speed is thus computed as 10/T (m/s). Both comfortable and fast gait speed can be measured. In the present study only comfortable gait speed was assessed.

  7 weeks

Secondary Outcomes (9)

• Follow-up score of Berg Balance Scale

  11 weeks

• Follow-up score of 10-meter Walk Test

  11 weeks

• Scores of Unified Parkinson's Disease Rating Scale - Motor examination (UPDRS-III)

  7 weeks and 11 weeks

• Scores of Timed Up and Go test

  7 weeks and 11 weeks

• Scores of Activities-specific Balance Confidence scale (ABC)

  7 weeks and 11 weeks

Study Arms (2)

Gamepad

EXPERIMENTAL

Biofeedback rehabilitation with Gamepad system.

Device: Gamepad system

Control

ACTIVE COMPARATOR

Conventional physiotherapy.

Other: Conventional physiotherapy

Interventions

Gamepad system DEVICE

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.

Gamepad

Conventional physiotherapy OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

Location

Related Publications (2)

• 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.

  PMID: 30607261 DERIVED

• 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.

  PMID: 27965005 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ilaria Carpinella, MSc

  Fondazione Don Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 21, 2016
• Study Start: January 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 21, 2016

Record last verified: 2016-03

Locations

IT (1)