Robotic Rehabilitation of Upper Limb in PD

NCT03893786 | Unknown

• 1 other identifier: 29/2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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

  2 months

• Nine hole peg test

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

  2 months

Secondary Outcomes (1)

• Upper Limb Fugl-Mayer

  2 months

Study Arms (2)

Robotic Treatment

EXPERIMENTAL

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

Conventional Treatment

ACTIVE COMPARATOR

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

Interventions

Robotic Rehabilitation DEVICE

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.

Conventional Treatment; Robotic Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic PD diagnosed according to the UK BRAIN BANK criteria
• Hoehn-Yahr stage 2- 3
• MMSE score ≥ 23

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi

Messina, Sicily, 98123, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: July 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

IT (1)