Robotic Rehabilitation of Upper Limb in PD

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Robotic Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Treatment<br>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. | Device: Robotic Rehabilitation<br>* 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.<br>|
| Active Comparator: Conventional Treatment<br>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. | Device: Robotic Rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Nine hole peg test | To evaluate if the patients will get better dexterity after the robotic training | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Limb Fugl-Mayer | to verify whether PD patients may present with an increase in muscle strenght after the treatment. | 2 months |