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Clinical Trials/NCT03893786
NCT03893786
Unknown
Not Applicable

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

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country30 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
30
Locations
1
Primary Endpoint
UPDRS rating scale- Section III
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
April 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rocco Salvatore Calabrò

Professor

IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Outcomes

Primary Outcomes

UPDRS rating scale- Section III

Time Frame: 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

Time Frame: 2 months

To evaluate if the patients will get better dexterity after the robotic training

Secondary Outcomes

  • Upper Limb Fugl-Mayer(2 months)

Study Sites (1)

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