Hand Rehab Using AMADEO in PD Patients (P-AMA)

The Use of AMADEO in Hand Rehabilitation in Patients With Parkinson Disease

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 Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: AMADEO; Other: Training; Other: OT Training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rossella Ciurleo; Phone Number: +3909060128109; Email: rosella.ciurleo@irccsme.it
• Study Contact Backup: Name: Rocco S Calabrò; Phone Number: +3909060128166; Email: salbro77@tiscali.it

Study Locations

• Italy
  • Messina, Italy, 98124
    • Recruiting
    • IRCCS Centro Neurolesi "Bonino-Pulejo"
    • Contact: Rossella Ciurleo; Email: rossella.ciurleo@irccsme.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMADEO Training; Twenty PD patients with hand bradykinesia will be treated with the AMADEO® system. They will undergo 15 training sessions, 5 a week for 3 weeks, each session lasting about 60 minutes. During each session, both the hands will be treated using the endeffector in its active and active-assisted modality.	Device: AMADEO; 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.; Other: Training; training
Active Comparator: OT training; Twenty control subjects (PD patients) will be treated with traditional rehabilitation focused on fine hand-finger movement skills. The patients in this group will undergo the same amount of treatment. Both the groups will be trained with conventional physiotherapy concerning postural, balance and gait.	Other: OT Training; training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine hole peg test	9HPT is used to measure finger dexterity in patients with various neurological diagnoses	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bipolar surface electromyography	EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles.	1 month

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Investigators: Study Chair: Rocco S Calabrò, IRCCS Centro Neurolesi

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 41/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No