Hand Rehab Using AMADEO in PD Patients

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: OT Training; Device: AMADEO; Other: Training

• Registration Number: NCT04045080
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Study Start: 2019-09-01
• Primary Completion: 2019-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMADEO Training	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.
OT 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.
AMADEO Training	AMADEO	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.

Primary Outcome Measures

Name	Time	Method
Nine hole peg test	1 month	9HPT is used to measure finger dexterity in patients with various neurological diagnoses

Secondary Outcome Measures

Name	Time	Method
Bipolar surface electromyography	1 month	EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles.

Trial Locations

Locations (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"; 🇮🇹 Messina, Italy