Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01102309
Other study ID # FIN-TN-2007
Secondary ID
Status Completed
Phase N/A
First received April 8, 2010
Last updated June 23, 2011
Start date October 2008
Est. completion date June 2011

Study information

Verified date June 2011
Source Eremo Hospital, Arco
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of HealthItaly: Autonomous Province of Trento
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Eremo Hospital of Arco Arco TN

Sponsors (2)

Lead Sponsor Collaborator
Eremo Hospital, Arco University of Padua

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Medical Research Council (MRC deltoid, biceps, triceps, wrist flexor, wrist extensor) Medical Research Council (MRC) is an ordinal scale for measuring strength of muscle force (range, 0 [no muscle contraction] to 5 [normal strength] for each muscle) in isolated or group muscle groups. We use this scale to rate the strength of the paretic arm during 5 actions: shoulder abduction (MRC deltoid), elbow flexion (MRC biceps), elbow extension (MRC triceps) wrist flexion (MRC wrist flexors) and extension (MRC wrist extension). 7 months No
Secondary Modified Ashworth Scale (MAS) Modified Ashworth scale (MAS) to test for hypertonia in several upper-limb joints (score, 0 - 5). A higher score on the modified Ashworth scale indicates higher tone, so a lower score indicates lower abnormal tone. The modified Ashworth scale (0 - 5) assesses the muscle tone of the shoulder adductors, the flexors of the elbow, wrist, and fingers (total AS-sum, 0-20). 7 months No
Secondary Functional Independent Measure (FIM) Functional Independent Measure (FIM) is an international standard measurement of disability. The FIM questionnaire explores 18 activities of daily living (13 items for self-care, sphincter control, mobility, locomotion, and 5 cognitive items). Each item can receive a score ranging from 1 (complete dependence) and 7 (complete self-sufficiency). The cumulative score and profile of scores under the various headings are standard indicators. 7 months No
Secondary Fatigue Severity Scale (FSS) The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on a person. The FSS is a short questionnaire that requires the patient to rate the level of fatigue. The FSS questionnaire contains nine statements that rate the severity of the fatigue symptoms. 7 months No
Secondary Upper-Motricity Index (upMI) Upper-Motricity Index (upMI) is an ordinal weighted instrument used to assess the severity of motor impairment to the upper limb after a stroke 7 months No
Secondary Trunk Control Test (TCT) TCT is a measurement scale evaluating control of trunk movements and stability. It assesses whether the patient can turn his body on the bed plane, maintain the sitting position and vary posture, yielding a score from 0 to 100. 7 months No
Secondary Short Form 12 The Short Form-12 Health Survey measures generic health concepts relevant across age, disease, and treatment groups. It provides a comprehensive, psychometrically sound, and efficient way to measure health from the patient's point of view by scoring standardized responses to standard questions. 7 months No
Secondary Box and Block Test Box and Block Test of manual dexterity assesses upper limb disability. It consists of two adjacent boxes of the same size, separated by a 15.2-cm high partition, with one of them filled with 150 blocks of 2.5 cm each. The patient performs the test with his unaffected and then with his affected upper extremity. The test evaluates the number of individual blocks could transport between the 2 boxes within 1 min. 7 months No
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis