Robotic Rehabilitation of Upper Limb in PD

NCT ID: NCT03893786

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-04-01

Brief 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robotic Treatment

Fifteen patients with Parkinson's Disease will perform ten 45-minutes training sessions of the upper limb using the Armeo®Spring applied bilaterally, an electromedical device aimed at improving force and coordination in neurologically affected patients.

The device was built to sustain the forearm during the upper limb training and it is equipped with a VR screen with which the patient may interact during the playful and motivating rehab.

Group Type: EXPERIMENTAL

Robotic Rehabilitation

Intervention Type: DEVICE

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.

Conventional Treatment

Fifteen patients with Parkinson's Disease will undergo ten 45-minutes training sessions of the upper limb with a traditional approach, performing the same excercises of the experimental group, i.e. flexo-extension of the wrist, prono-supination of the forearm, etcc.

Group Type: ACTIVE_COMPARATOR

Robotic Rehabilitation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Rocco Salvatore Calabrò

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Neurolesi

Messina, Sicily, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Rossella Ciurleo, PhD

Role: primary

rosella.ciurleo@irccsme.it

+390906018159

Other Identifiers

29/2018

Identifier Type: -

Identifier Source: org_study_id