Clinical trial NCT01102309: Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients
Official title: Clinical and Social-economic Impact Assessment of Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Accident
Upper Extremity Paresis
Keywords: cerebrovascular accident
hemiparesis
recovery of function
rehabilitation
robotics
subacute therapy
training
Lead sponsor: Eremo Hospital, Arco
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2010-04-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study aims to test a robotic rehabilitation protocol which involves the use of a robotic device (NeReBot) as an alternative to the conventional rehabilitation treatment. NeReBot is a 3-degree-of-freedom robotic device, which can be programmed by the therapist to perform repetitive assistive movements (flexion and extension, adduction and abduction, pronation and supination, circular) of the upper limb (shoulder and elbow), combined with a visual and acoustic display. Acute and subacute stroke patients (≤20 days post-stroke) will be randomized into two groups with a procedure by a computer program: the experimental group (EG) and the control group (CG). Both groups will receive a total daily treatment time of 120 minutes for five days a week and for five weeks. The EG will perform the conventional functional rehabilitation (proprioceptive exercises, verticalization, gait training, paretic hand and wrist mobilization, without mobilizing the proximal paretic arm) and occupational therapy for 80 minutes a day, while the proximal paretic arm will be treated by NeReBot for 40 minutes a day. For the CG, NeReBot therapy is substituted by 40 minutes of conventional mobilization of the proximal paretic arm by the therapist.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Fugl-Meyer (FM-SEC and FM-WH)
timeFrame: 7 months
measure: Motor-Functional Independence Measure (m-FIM)
timeFrame: 7 months
measure: Frenchay Arm Test (FA-T)
timeFrame: 7 months
Secondary outcomes:
measure: Medical Research Council (MRC deltoid, biceps, triceps, wrist flexor, wrist extensor)
timeFrame: 7 months
measure: Modified Ashworth Scale (MAS)
timeFrame: 7 months
measure: Functional Independent Measure (FIM)
timeFrame: 7 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 7 months
measure: Upper-Motricity Index (upMI)
timeFrame: 7 months
measure: Trunk Control Test (TCT)
timeFrame: 7 months
measure: Short Form 12
timeFrame: 7 months
measure: Box and Block Test
timeFrame: 7 months
Other outcomes:
Locations:
city: Arco
country: Italy
facility: Eremo Hospital of Arco
state: TN
Study officials:
affiliation: Eremo Hospital, Arco
name: Mario Armani, MD
role: STUDY_DIRECTOR
affiliation: University of Padova
name: Stefano Masiero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova
name: Giulio Rosati, PhD
role: STUDY_CHAIR
affiliation: University of Padova
name: Aldo Rossi
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.