Hand Rehab Using AMADEO in PD Patients

Last updated: March 18, 2024
Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

AMADEO

Training

OT Training

Clinical Study ID

NCT04045080
41/19
  • Ages 45-80
  • All Genders

Study Summary

Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Idiopathic PD diagnosed according to the Gelb's criteria;

  • Hoehn-Yahr stage 1- 3

  • "On" state

  • MMSE score ≥ 24

  • Willing and able to give written informed consent;

  • Willing and able to comply with the study procedures.

Exclusion Criteria

  • A specific kind of fluctuation: Sudden on-off fluctuations

  • History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;

  • History of stereotaxic brain surgery for PD;

  • Mini-mental examination (MMSE) score less than 24 at screening;

  • Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;

  • Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline;

  • Presence of severe dyskinesia prior to baseline;

  • Any other medical or psychiatric condition that may compromise the patient's participation in this study;

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: AMADEO
Phase:
Study Start date:
September 01, 2019
Estimated Completion Date:
June 01, 2024

Connect with a study center

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

    Messina, 98124
    Italy

    Active - Recruiting

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