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

Eremo Hospital, Arco

Status: Completed

Conditions: Cerebrovascular Accident; Upper Extremity Paresis; Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01102309

FIN-TN-2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

Group assigned to robot plus conventional therapy

Treatment:

Other: Conventional therapy

Device: Robot therapy (NeReBot)

Control Group (CG)

Active Comparator group

Description:

Group assigned to conventional therapy only

Treatment:

Other: Conventional therapy