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Robotic Rehabilitation of Upper Limb in PD

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Robotic Rehabilitation
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • IRCCS NeurolesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Treatment

Conventional Treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
Nine hole peg test
To evaluate if the patients will get better dexterity after the robotic training

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2019
Last Updated
July 30, 2019
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT03893786
Brief Title
Robotic Rehabilitation of Upper Limb in PD
Official Title
Upper Limb Rehabilitation Using Armeo Spring in Patients With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Robotic Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
UPDRS rating scale- Section III
Description
To assess whether PD patients may got better results in the motor part of the UPDRS after the UL training
Time Frame
2 months
Title
Nine hole peg test
Description
To evaluate if the patients will get better dexterity after the robotic training
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Upper Limb Fugl-Mayer
Description
to verify whether PD patients may present with an increase in muscle strenght after the treatment.
Time Frame
2 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
IRCCS Neurolesi
City
Messina
State/Province
Sicily
ZIP/Postal Code
98123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rossella Ciurleo, PhD
Phone
+390906018159
Email
rosella.ciurleo@irccsme.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Robotic Rehabilitation of Upper Limb in PD

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