Upper Limb Treatment With "Gloreha Aria" in the Hemiplegic Patients

Feasibility and Efficacy of the Upper Limb Treatment With "Gloreha Aria" in the Hemiplegic Patients: a Randomized Pilot Study

Stroke is one of the leading causes of death and disability and has been described as a worldwide epidemic (1). Stroke survivors are affected by impairments and limitations of cognitive, language, perceptual, sensory, and motor functions. After a stroke, patients can improve spontaneously within the first 3 months (2) and then more slowly in the following year. The first day, decreased oedema and partial reperfusion of the ischemic penumbra may possibly explain these phenomena, but the improvement of neurological deficit in the following weeks suggests plasticity phenomena and brain cortical reorganization (3). While most recovery is thought to be made in the first few weeks after stroke, patients may make improvements on functional tasks many months after having a stroke (4). Restoring arm and hand skill after a stroke remains challenging, even though stroke rehabilitation programs have proven partial efficacy Repetitive task training has been shown to be effective in some aspects of rehabilitation, such as improving walking distance and speed and improving upper limb function (5).

In this project, the investigators will use "Gloreha ARIA" (7) a new sensor-based therapy device designed for motor recovery of impaired upper limb Gloreha Aria offers specific programs that help patients to move arm, wrist and fingers. Therapists can customize therapy by focusing on a specific motor task.

Study Overview

• Status: Completed
• Conditions: Upper Extremity Injury; Hemiplegia and/or Hemiparesis Following Stroke
• Intervention / Treatment: Device: Gloreha Aria; Other: Usual care

Detailed Description

The hypothesis was that rehabilitation with this device could be not inferior in comparison with hands-on physiotherapy, in the reeducation of upper arm in the patient affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before.

The principle purpose of this study will be to evaluate:

1. The feasibility of this new device
2. Efficacy in improving arm function abilities in the rehabilitation of patients with stroke in the sub-acute phase.

Post-stroke patients admitted for inpatient rehabilitation to the Neurological Rehabilitation will be screened for enrolment and randomized in a controlled trial.

All the patients will be informed about the aim and experimental procedures before enrolment, thus written informed consent will be obtained from all of them. Patients included in the study will be randomly assigned to intervention or control group according to simple randomization technique (computerized random numbers).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Istituti Clinici Scientifici Maugeri IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• to exhibit first cerebral vascular disease with unilateral hemispherical lesion confirmed by CT scan or MRI;
• to be sub-acute patients (less than 30 days from the cerebral vascular event);
• being affected by upper limb paresis;

Exclusion Criteria:

1. unable to understand verbal instruction or motor commands;
2. unilateral neglect;
3. apraxia;
4. significant visual impairment;
5. unstable medical condition;
6. significant orthopedic limitation to the shoulder, elbow; wrist and hand;
7. upper arm peripherical nerve lesion;
8. neuromuscular or neurodegenerative diseases;
9. spasticity > 3 in according to the Modifies Ashworth Scale (3);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; The specific hand intervention consisted of 30 sessions, lasting 60 min/ day, for 6 days/week. All patients will be educated by physiotherapist to perform the movements for wrist, hand and arm in complete autonomy. In Treatment Group, the movements will be performed using Gloreha ARIA. Gloreha Aria is a sensor-based therapy device designed for motor recovery of impaired upper limb. Gloreha Aria is equipped with sensors that can detect any movements in space: the software processes and displays them on the screen.	Device: Gloreha Aria; Device offers specific programs that help patients to move arm, wrist and fingers
Active Comparator: Participants Usual Care (PUC); The specific hand intervention consisted of 30 sessions, lasting 60 min/ day, for 6 days/week. All patients will be educated by physiotherapist to perform the movements for wrist, hand and arm in complete autonomy.In Control Group, these activates will be performed without any device.	Other: Usual care; Conventional occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of FMA-UE (Fugl-Meyer assessment upper extremity).	Assessment of sensorimotor function.	From date of randomization (T0) until the to the end of the study (T1) after an intervention lasting over a period of about 6 weeks, assessed after 30 rehabilitation sessions, lasting 30 min/ day each and performed 5 days/week.

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Investigators: Principal Investigator: Fabio Vanoglio, PT, Istituti Clinici Scientifici Maugeri

Publications and helpful links

General Publications

• Chen R, Cohen LG, Hallett M. Nervous system reorganization following injury. Neuroscience. 2002;111(4):761-73. doi: 10.1016/s0306-4522(02)00025-8.
• Bennett DA, Krishnamurthi RV, Barker-Collo S, Forouzanfar MH, Naghavi M, Connor M, Lawes CM, Moran AE, Anderson LM, Roth GA, Mensah GA, Ezzati M, Murray CJ, Feigin VL; Global Burden of Diseases, Injuries, and Risk Factors 2010 Study Stroke Expert Group. The global burden of ischemic stroke: findings of the GBD 2010 study. Glob Heart. 2014 Mar;9(1):107-12. doi: 10.1016/j.gheart.2014.01.001.
• Maulden SA, Gassaway J, Horn SD, Smout RJ, DeJong G. Timing of initiation of rehabilitation after stroke. Arch Phys Med Rehabil. 2005 Dec;86(12 Suppl 2):S34-S40. doi: 10.1016/j.apmr.2005.08.119.
• Teasell RW, Murie Fernandez M, McIntyre A, Mehta S. Rethinking the continuum of stroke rehabilitation. Arch Phys Med Rehabil. 2014 Apr;95(4):595-6. doi: 10.1016/j.apmr.2013.11.014. Epub 2014 Feb 14.
• French B, Thomas LH, Coupe J, McMahon NE, Connell L, Harrison J, Sutton CJ, Tishkovskaya S, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2016 Nov 14;11(11):CD006073. doi: 10.1002/14651858.CD006073.pub3.

Helpful Links

• Brochure of Gloreha ARIA device

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Paralysis; Hemiplegia; Paresis; Arm Injuries
• Other Study ID Numbers: ICS Maugeri - CE 2208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No