Robotic Rehabilitation of Upper Limb in PD

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: Robotic Rehabilitation

• Registration Number: NCT03893786
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Status Verified: 2019-07
• Study Start: 2019-07-01
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Treatment	Robotic Rehabilitation	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.
Conventional Treatment	Robotic Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
UPDRS rating scale- Section III	2 months	To assess whether PD patients may got better results in the motor part of the UPDRS after the UL training
Nine hole peg test	2 months	To evaluate if the patients will get better dexterity after the robotic training

Secondary Outcome Measures

Name	Time	Method
Upper Limb Fugl-Mayer	2 months	to verify whether PD patients may present with an increase in muscle strenght after the treatment.

Trial Locations

Locations (1)

IRCCS Neurolesi; 🇮🇹 Messina, Sicily, Italy