Hand Rehab Using AMADEO in PD Patients

IRCCS Centro Neurolesi Bonino Pulejo40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

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. Moreover, even without muscular strength, active work can be done using EMG-based training. The Continuous Passive Motion (CPM Plus) therapy facilitates the implementation of automatic movement sequences even when the patient is unable to complete the entire range of motion on their own. It may be used in all phases of finger-hand rehabilitation and can be adapted to the needs of every patient. In patients with PD, it will be useful in improving bradykinesia and potentially distal hypostenia.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Nine hole peg test

9HPT is used to measure finger dexterity in patients with various neurological diagnoses

Time frame: 1 month

Secondary Outcomes

Bipolar surface electromyography

EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles.