Robotic Rehabilitation of Upper Limb in PD

Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo" (Other)
Overall Status
Unknown status
CT.gov ID
NCT03893786
Collaborator
(none)
30
1
2
9
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Robotic Rehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Upper Limb Rehabilitation Using Armeo Spring in Patients With Parkinson's Disease.
Actual Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: 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.

Active Comparator: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Nine hole peg test [2 months]

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

Secondary Outcome Measures

  1. Upper Limb Fugl-Mayer [2 months]

    to verify whether PD patients may present with an increase in muscle strenght after the treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Neurolesi Messina Sicily Italy 98123

Sponsors and Collaborators

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rocco Salvatore Calabrò, Professor, IRCCS Centro Neurolesi "Bonino-Pulejo"
ClinicalTrials.gov Identifier:
NCT03893786
Other Study ID Numbers:
  • 29/2018
First Posted:
Mar 28, 2019
Last Update Posted:
Aug 1, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2019