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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Cerebrovascular Accident Upper Extremity Paresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group (EG)

Group assigned to robot plus conventional therapy

Group Type EXPERIMENTAL

Robot therapy (NeReBot)

Intervention Type DEVICE

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

Conventional therapy

Intervention Type OTHER

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

Control Group (CG)

Group assigned to conventional therapy only

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

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

Interventions

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Robot therapy (NeReBot)

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

Intervention Type DEVICE

Conventional therapy

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

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No