Robotic Rehabilitation of Upper Limb in PD

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Unknown

Conditions: Parkinson Disease

Treatments: Device: Robotic Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03893786

29/2018

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Robotic Treatment

Experimental group

Description:

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.

Treatment:

Device: Robotic Rehabilitation

Conventional Treatment

Active Comparator group

Description:

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.

Treatment:

Device: Robotic Rehabilitation