Robotic Rehabilitation of Upper Limb in PD

Parkinson Disease Clinical Trial

Official title:

Upper Limb Rehabilitation Using Armeo Spring in Patients With Parkinson's Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03893786
• Other study ID #: 29/2018
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2019
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. Thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to improve motor function. The ARMEO-S® is a specific upper limb electromedical device mainly used to reduce spasticity and improve muscle force. To date robotic upper limb training has been applied only in patiebts with brain injury and spinal cord lesions.

Aim of the study is to evaluate the efficacy of ARMEO-S in improving upper limb agility in a sample of PD patients, as compared to traditional physiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Idiopathic PD diagnosed according to the UK BRAIN BANK criteria

• Hoehn-Yahr stage 2- 3

• MMSE score = 23

Exclusion Criteria:

• Severe Dyskinesia

• On-Off Motor fluctuations

• History of stereotaxic brain surgery for PD;

• Changes in dopamine therapy dose in any time within 3 months prior to baseline;

• Any other medical that may compromise the patient's participation in this study such as history of ostheoarthritis or neuropathies.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Robotic Rehabilitation
Fifteen patients with Parkinson's Disease will perform ten 45-minute training sessions of the upper limb bilaterally with the Armeo®Spring, an electromedicad device aimed at improving force and coordination in neurologically affected patients. The device was built to sustain the forearm during the upperlimb training and is equipped with a VR screen with which the patient may interact during the playful and motivating rehab.

Locations

Country	Name	City	State
Italy	IRCCS Neurolesi	Messina	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS rating scale- Section III	To assess whether PD patients may got better results in the motor part of the UPDRS after the UL training	2 months
Primary	Nine hole peg test	To evaluate if the patients will get better dexterity after the robotic training	2 months
Secondary	Upper Limb Fugl-Mayer	to verify whether PD patients may present with an increase in muscle strenght after the treatment.	2 months