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Multi-segmental Robotic and Technological Upper Limb Rehabilitation in Stroke

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ClinicalTrials.gov Identifier: NCT02879279
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Irene Giovanna Aprile, Fondazione Don Carlo Gnocchi Onlus

Brief Summary:
Stroke is frequently associated with significant disability and impaired quality of life. Persistent motor impairment is common with often incomplete recovery of motor function in response to rehabilitation, mainly in the upper limbs. Robot-mediated therapy has been proposed as a viable approach for the rehabilitation of the upper limb, but as the evidence quality is low, more rigorous studies are needed. Previous studies have focused on the effects of devices acting on a limited number of joints, often limiting the workspace on a plane. This study aims to evaluate the efficacy of a multi-set of robotic and technological devices for the rehabilitation of the upper limb in sub-acute stroke patients.

Condition or disease Intervention/treatment Phase
Stroke Device: Amadeo, Pablo, Diego and Motore. Other: Conventional rehabilitation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Multi-segmental Robotic and Technological Upper Limb Rehabilitation Program, Compared With Traditional Therapy, in Individuals With Acute and Sub-acute Stroke: a Multicenter, Randomized, Controlled Clinical Trial.
Study Start Date : May 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Robotic rehabilitation
In the robotic rehabilitation group, both the distal and the proximal parts of the patients' upper arm will be treated by means of a multi-set of robotic and technological devices, i.e, Amadeo, Pablo, Diego and Motore. The aforementioned systems can be used to perform three-dimensional movements of the shoulder, planar movements of the shoulder and elbow, prono-supination movements of the forearm, flexion-extension movements of the wrist, bimanual movements, and flexion/extension movements of the fingers. A vibratory treatment will be applied, using the Amadeo, to increase the proprioception of the hand. Motor and cognitive tasks, comprising active, passive and active-assistive, will be performed during the treatment. Visual and auditory feedback will be provided to help the patients.
Device: Amadeo, Pablo, Diego and Motore.
In the robotic rehabilitation group, patients will be treated with the following systems: Amadeo, Pablo and Diego (Tyromotion GmbH, Austria), and Motore (Humanware, Italy). A ratio of one therapist to every 3 or 4 patients will be used, depending on the patient's severity. The rehabilitation treatment will be performed daily for 45 minutes, for 5 days per week, for 6 weeks. A total of 30 sessions will be performed.

Active Comparator: Conventional rehabilitation
In the conventional rehabilitation group, patients will undergo a conventional treatment. The therapeutic tasks will focus on sensorimotor reprogramming, hypertonus inhibition, functional improvement, including task-oriented exercises. Specifically, patients will perform passive, active and active assisted exercises on the three upper limb joints, to improve joint function, to prevent contractures, to inhibit hypertonus and to improve trophism and motor function.
Other: Conventional rehabilitation
In the conventional rehabilitation group, patients will undergo a conventional treatment with a ratio of one therapist to one patient. The rehabilitation treatment will be performed daily for 45 minutes, for 5 days per week, for 6 weeks. A total of 30 sessions will be performed.




Primary Outcome Measures :
  1. Change from Baseline Fugl-Meyer Assessment of Motor Recovery after Stroke (Upper Extremity portion) [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia


Secondary Outcome Measures :
  1. Change from Baseline Motricity Index [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is a scale to evaluate the motor impairment in a patient who has had a stroke.

  2. Change from Baseline British Medical Research Council Scale (Shoulder, Elbow and Wrist) [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is a scale to test muscle strength

  3. Change from Baseline Modified Ashworth Scale (Shoulder, Elbow and Wrist) [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is a scale to measure spasticity

  4. Change from Baseline Frenchay Activities Index [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is designed to assess functional status in stroke patients

  5. Change from Baseline Action Research Arm Test [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is designed to assess upper limb functioning using observational methods

  6. Change from Baseline Douleur Neuropathique 4 [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is designed to assess pain and to distinguish nociceptive from neuropathic pain

  7. Change from Baseline Numeric Rating Scale [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is a scale to assess pain

  8. Change from Baseline Modified Barthel Index [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is designed to assess the ability of an individual with a neuromuscular or musculoskeletal disorder to care for him/herself

  9. Change from Baseline Short Form-36 [ Time Frame: Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2) ]
    It is a 36 item questionnaire which measures Quality of Life.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute or sub-acute patients, with ischemic and hemorrhagic stroke, verified by MRI or CT
  2. Age between 40 and 80 years;
  3. Time latency since stroke ranging from two weeks to six months
  4. Cognitive and language abilities that are sufficient to understand the experiments and follow instructions

Exclusion Criteria:

  1. Behavioral and cognitive disorders and/or reduced compliance that would interfere with active therapy;
  2. Fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4);
  3. Severe deficits in visual acuity;
  4. Upper extremity Fugl-Meyer score >58.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879279


Locations
Italy
Don Gnocchi Foundation
Rome, Italy, 00168
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Investigators
Principal Investigator: Irene Aprile, MD, PhD Don Gnocchi Foundation

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irene Giovanna Aprile, M.D., PhD, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02879279     History of Changes
Other Study ID Numbers: FDG_MUR
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Irene Giovanna Aprile, Fondazione Don Carlo Gnocchi Onlus:
Stroke
Upper limb
Robotic rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases