Hand Rehab Using AMADEO in PD Patients

NCT ID: NCT04045080

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2024-06-01

Brief 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

AMADEO

Intervention Type: DEVICE

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.

Training

Intervention Type: OTHER

training

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.

Group Type: ACTIVE_COMPARATOR

OT Training

Intervention Type: OTHER

training

Interventions

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.

Intervention Type: DEVICE

Training

training

Intervention Type: OTHER

OT Training

training

Intervention Type: OTHER

Eligibility 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;

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Rocco Salvatore Calabrò

Medical Director, Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rocco S Calabrò

Role: STUDY_CHAIR

IRCCS Centro Neurolesi

Locations

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Rocco S Calabrò

Role: CONTACT

salbro77@tiscali.it

+3909060128166

Rossella Ciurleo

Role: CONTACT

rosella.ciurleo@irccsme.it

+3909060128109

Facility Contacts

Rossella Ciurleo

Role: primary

rossella.ciurleo@irccsme.it

Other Identifiers

41/19

Identifier Type: -

Identifier Source: org_study_id