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

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: OT Training; Device: AMADEO; Other: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04045080

41/19

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

AMADEO Training

Experimental group

Description:

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.

Treatment:

Other: Training

Device: AMADEO

OT training

Active Comparator group

Description:

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.

Treatment:

Other: OT Training