Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients

NCT01102309 | Completed

• 1 other identifier: FIN-TN-2007
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine if robot aided rehabilitation therapy can be equivalent to or more effective than conventional rehabilitation therapy at promoting functional recovery of the paretic upper limb in acute and subacute stroke patients.

Conditions

Stroke; Cerebrovascular Accident; Upper Extremity Paresis

Keywords

cerebrovascular accident; hemiparesis; recovery of function; rehabilitation; robotics; subacute therapy; training

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer (FM-SEC and FM-WH)

  Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the test includes items related to movements of the shoulder, elbow, forearm (proximal arm), and wrist and hand (distal arm). The total scores range between 0 and 66. We considered the shoulder/elbow and coordination subsections (FM-SEC = 42/66 items) and the wrist/hand subsection (FM-WH = 24/66 items).

  7 months

• Motor-Functional Independence Measure (m-FIM)

  Motor-Functional Independent Measure (m-FIM) is a test to measure improvements in basic motor ADL, outcomes and the degree of self-care. The motor-FIM is a subsection of Functional Indipendence Measure that is an ordinal scale that assesses severity of motor disability, composed of 13-item motor subscale (including self-care, sphincter control, mobility, locomotion) with a scoring ranges between 13 and 91; each item envisages 7 levels of performance independence (7 is total independence, 1 is total dependence or unassessable).

  7 months

• Frenchay Arm Test (FA-T)

  Franchey Arm Test (FA-T) evaluates five activities of daily living: lifting and replacing of a glass, drawing a line with the use of a ruler, combing the hair, lifting and replacing of a cylinder \[5 cm long\], removing of a sprung clothes peg from a dowel and replacing it; 0 = worst score; 5 = best score).It reflects both hand and arm functions.

  7 months

Secondary Outcomes (8)

• Medical Research Council (MRC deltoid, biceps, triceps, wrist flexor, wrist extensor)

  7 months

• Modified Ashworth Scale (MAS)

  7 months

• Functional Independent Measure (FIM)

  7 months

• Fatigue Severity Scale (FSS)

  7 months

• Upper-Motricity Index (upMI)

  7 months

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

Group assigned to robot plus conventional therapy

Device: Robot therapy (NeReBot); Other: Conventional therapy

Control Group (CG)

ACTIVE COMPARATOR

Group assigned to conventional therapy only

Other: Conventional therapy

Interventions

Robot therapy (NeReBot) DEVICE

Rehabilitation therapy of the affected arm with NeRebot for five weeks, five times weekly for 40 minutes, plus 80 minutes of conventional therapy

Experimental Group (EG)

Conventional therapy OTHER

Conventional rehabilitation therapy of the affected arm for five weeks, five times weekly for 120 minutes

Control Group (CG); Experimental Group (EG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• recent unilateral single stroke (ischemic or hemorrhagic) verified by brain CT or MRI;
• sufficient cognitive and language skills to understand the instructions of the operator (assessed by Modified Mini-Mental State Examination \> 21);
• patients with upper limb paralysis (Motor Power score between 8 and 12);
• written informed consent signed by the patient (or an authorized representative).

You may not qualify if:

• cardiovascular instability (severe uncontrolled hypertension, severe coronary artery disease, etc.) or orthopedic, or neurological conditions;
• presence of multiple cerebrovascular lesions (usually the result of many ischemic episodes in the past);
• early appearance of marked spasticity (≥ 3 according to Ashworth Scale);
• joint pain or limited joint range of motion (ROM) of the upper limb that results in the inability to complete the protocol;
• severe neuropsychologic impairment (global aphasia, severe attention deficit or neglect), affecting the patient's ability to follow instructions;

Sponsors & Collaborators

• Eremo Hospital, Arco: lead
• University of Padova: collaborator

Study Sites (1)

Eremo Hospital of Arco

Arco, TN, I-38062, Italy

Location

Related Publications (2)

• Masiero S, Armani M, Rosati G. Upper-limb robot-assisted therapy in rehabilitation of acute stroke patients: focused review and results of new randomized controlled trial. J Rehabil Res Dev. 2011;48(4):355-66. doi: 10.1682/jrrd.2010.04.0063.

  PMID: 21674388 RESULT

• Masiero S, Armani M, Ferlini G, Rosati G, Rossi A. Randomized trial of a robotic assistive device for the upper extremity during early inpatient stroke rehabilitation. Neurorehabil Neural Repair. 2014 May;28(4):377-86. doi: 10.1177/1545968313513073. Epub 2013 Dec 6.

  PMID: 24316679 DERIVED

Related Links

• Website of the rehabilitation robotics research group in Padua, Italy
• Description of the robotic device employed in the clinical trial

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario Armani, MD

  Eremo Hospital, Arco

  STUDY DIRECTOR

• Stefano Masiero, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

• Giulio Rosati, PhD

  University of Padova

  STUDY CHAIR

• Aldo Rossi

  University of Padova

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 13, 2010
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

IT (1)