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StrokeNCT01102309

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

A study testing Robot therapy (NeReBot) and Conventional therapy in people with Stroke and Cerebrovascular Accident, run by Eremo Hospital, Arco at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Robot therapy (NeReBot) and Conventional therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteItaly
Study dates
Oct 2008to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Eremo Hospital of Arco

    Arco, TN, I-38062

Other trials in Italy

About this study

Official title: Clinical and Social-economic Impact Assessment of Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients

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.

Read the 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.

Being tested
Robot therapy (NeReBot), Conventional therapy
Keywords
cerebrovascular accident, hemiparesis, recovery of function, rehabilitation, robotics, subacute therapy, training
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Conventional therapyOther

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

Study groups in NCT01102309
Study groupRoleWhat they receive
Experimental Group (EG)ExperimentalGroup assigned to robot plus conventional therapy
Receives: Device: Robot therapy (NeReBot); Other: Conventional therapy
Control Group (CG)Active comparatorGroup assigned to conventional therapy only
Receives: Other: Conventional therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 7 months

  2. 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).

    Measured: 7 months

  3. 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.

    Measured: 7 months

Secondary outcomes (8)

  1. 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).

    Measured: 7 months

  2. 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).

    Measured: 7 months

  3. 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.

    Measured: 7 months

  4. 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.

    Measured: 7 months

  5. 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

    Measured: 7 months

  6. 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.

    Measured: 7 months

  7. 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.

    Measured: 7 months

  8. 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.

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2010 (estimated)
  2. Study startOct 2008
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01102309
Sponsor's protocol ID
FIN-TN-2007
Status last verified
Jun 2011
First submitted
8 Apr 2010
Last updated
27 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21674388

  • 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.

    PubMed 24316679

Questions about this trial

What is this clinical trial studying?

A study testing Robot therapy (NeReBot) and Conventional therapy in people with Stroke and Cerebrovascular Accident, run by Eremo Hospital, Arco at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer (FM-SEC and FM-WH) (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01102309, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.

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