Parkinson Disease
Conditions
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.
Interventions
DEVICEAMADEO
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.
OTHERTraining
training
OTHEROT Training
training
Sponsors
IRCCS Centro Neurolesi Bonino Pulejo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nine hole peg test | 1 month | 9HPT is used to measure finger dexterity in patients with various neurological diagnoses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bipolar surface electromyography | 1 month | EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles. |
Countries
Italy
Contacts
Primary ContactRocco S Calabrò
Backup ContactRossella Ciurleo
Outcome results
None listed