Hand Rehab Using AMADEO in PD Patients

NCT04045080 | Recruiting DMC

• 1 other identifier: 41/19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Nine hole peg test

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

  1 month

Secondary Outcomes (1)

• Bipolar surface electromyography

  1 month

Study Arms (2)

AMADEO Training

EXPERIMENTAL

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; Other: Training

OT training

ACTIVE COMPARATOR

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

Interventions

AMADEO 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.

AMADEO Training

Training OTHER

training

AMADEO Training

OT Training OTHER

training

OT training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Rocco S Calabrò

  IRCCS Centro Neurolesi

  STUDY CHAIR

Central Study Contacts

Rocco S Calabrò

CONTACT

+3909060128166; salbro77@tiscali.it

Rossella Ciurleo

CONTACT

+3909060128109; rosella.ciurleo@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neurologist

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 5, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)