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

NCT03738813 | Completed

• 1 other identifier: ICS Maugeri - CE 2208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia and/or Hemiparesis Following Stroke; Upper Extremity Injury

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Participants Usual Care (PUC)

ACTIVE COMPARATOR

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

Interventions

Gloreha Aria DEVICE

Device offers specific programs that help patients to move arm, wrist and fingers

Treatment Group

Usual care OTHER

Conventional occupational therapy

Participants Usual Care (PUC)

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

Location

Related Publications (5)

• 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.

  PMID: 25432120 BACKGROUND

• 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.

  PMID: 16373138 BACKGROUND

• 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.

  PMID: 12031403 BACKGROUND

• 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.

  PMID: 24529594 BACKGROUND

• 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.

  PMID: 27841442 BACKGROUND

MeSH Terms

Conditions

Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Fabio Vanoglio, PT

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: November 13, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: September 7, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

IT (1)