Hand Rehab Using AMADEO in PD Patients

Parkinson Disease Clinical Trial

— P-AMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045080
• Other study ID #: 41/19
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Rocco S Calabrò
• Phone: +3909060128166
• Email: salbro77[@]tiscali.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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
• OT Training
training

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi "Bonino-Pulejo"	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nine hole peg test	9HPT is used to measure finger dexterity in patients with various neurological diagnoses	1 month
Secondary	Bipolar surface electromyography	EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles.	1 month