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Parkinson DiseaseGAMEPAD_PDNCT02713971

Biofeedback Rehabilitation in Parkinson's Disease

A study testing Gamepad system and Conventional physiotherapy in people with Parkinson Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Gamepad system and Conventional physiotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteItaly
Study dates
Jan 2013to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione Don Gnocchi ONLUS

    Milan, 20148

Other trials in Italy

About this study

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

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.

Being tested
Gamepad system, Conventional physiotherapy
Keywords
Rehabilitation, Balance, Gait, Biofeedback
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamepad systemDevice

    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.

  • Conventional physiotherapyOther

    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.

Study groups in NCT02713971
Study groupRoleWhat they receive
GamepadExperimentalBiofeedback rehabilitation with Gamepad system.
Receives: Device: Gamepad system
ControlActive comparatorConventional physiotherapy.
Receives: Other: Conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 weeks

  2. 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.

    Measured: 7 weeks

Secondary outcomes (9)

  1. Follow-up score of Berg Balance Scale

    Score of Berga Balance Scale assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure.

    Measured: 11 weeks

  2. Follow-up 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.

    Measured: 11 weeks

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

    Score of UPDRS-III assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.

    Measured: 7 weeks and 11 weeks

  4. Scores of Timed Up and Go test

    Score of Timed Up and Go test assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.

    Timed Up and Go test is a mobility test evaluating the time taken by the subject to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down.

    Measured: 7 weeks and 11 weeks

  5. Scores of Activities-specific Balance Confidence scale (ABC)

    Score of ABC assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.

    Activities-specific Balance Confidence scale is a questionnaire through which the subject rates his/her perceived level of confidence while performing 16 daily living activities. Scores range from 0% (not confident) to 100 % (completely confident).

    Measured: 7 weeks and 11 weeks

  6. Scores of Freezing Of Gait Questionnaire (FOGQ)

    Score of FOGQ assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.

    Freezing Of Gait Questionnaire evaluates freezing severity with a 6-item interview. Each item is rated on a 5-point ordinal scale from 0 (absence of freezing) to 4 (severe freezing).

    Measured: 7 weeks and 11 weeks

  7. Scores of Parkinson's Disease Questionnaire-39 (PDQ-39(

    Score of PDQ-39 assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.

    Parkinson's Disease Questionnaire-39 is a 39-item, self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life over the last month. Scores are from 0 to 100, with 100 representing maximum level of problems.

    Measured: 7 weeks and 11 weeks

  8. Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)

    TSQ-WT consists in six areas (Benefit, Usability, Self-concept, Privacy and loss of control, Quality of life, and Wearing comfort) that evaluate the satisfaction of the subject with the wearable part of a system. Each area includes 5 statements rated by the user on a 5-pint Likert scale between 0 (strongly disagree with the statement) and 4 (strongly agree with the statement). In the present study, only Benefit, Usability and Wearing Comfort areas were administered. TSQ-WT was administered to the Gamepad Group only.

    Measured: 7 weeks

  9. Amplitude of body sway in antero-posterior (Sway AP) and medio-lateral (Sway ML) directions

    Sway AP and ML assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.

    Subjects were tested for 30 seconds during upright standing on a stabilometric force platform in four sensory conditions: eyes open, eyes closed, eyes open with foam pads under feet, and eyes closed with foam pads under feet. Center of Pressure (CoP) sway in AP and ML directions was computed as the standard deviation of the time-course of AP and ML CoP displacements recorded by the platform.

    Measured: 7 weeks and 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2016 (estimated)
  2. Study startJan 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02713971
Sponsor's protocol ID
GR-2009-1604984-GAMEPAD
Acronym
GAMEPAD_PD
Status last verified
Mar 2016
First submitted
8 Mar 2016
Last updated
21 Mar 2016
Results posted
No

Publications

  • 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.

    PubMed 30607261

  • 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.

    PubMed 27965005

Questions about this trial

What is this clinical trial studying?

A study testing Gamepad system and Conventional physiotherapy in people with Parkinson Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-treatment score of Berg Balance Scale (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02713971, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.

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