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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Centro Neurolesi Bonino-Pulejo
RECRUITING
Messina
Contact Information
Primary
Rocco S Calabrò
salbro77@tiscali.it
+3909060128166
Backup
Rossella Ciurleo
rosella.ciurleo@irccsme.it
+3909060128109
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2024-06-01
Participants
Target number of participants: 40
Treatments
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.
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.
Sponsors
Leads: IRCCS Centro Neurolesi Bonino Pulejo

This content was sourced from clinicaltrials.gov