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Socially Assistive Robot in Upper-Limb Neurorehabilitation

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ClinicalTrials.gov Identifier: NCT03651063
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Shelly Levy-Tzedek, Ben-Gurion University of the Negev

Brief Summary:
30 one year post stroke patients with upper limb paresis will be recruited to this study. The study is an RCT consists of three groups of intervention: 1. social robot, 2. computer, 3. self training. the intervention consists of 15 therapy sessions of reach-to-grasp games of the affected upper limb.

Condition or disease Intervention/treatment Phase
Upper Extremity Paralysis Other: social robot Other: computer group Other: self-training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 groups, each group will have a different intervention program
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Socially Assistive Robot in Upper-Limb Neurorehabilitation: A Long-Term Intervention RCT Using Behavioral Techniques
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: social robot group Other: social robot
Reach To Grasp games with a social robot

Active Comparator: computer group Other: computer group
reach to grasp games with a computer screen

Active Comparator: self-training group Other: self-training
reach to grasp games with no externa feedback.




Primary Outcome Measures :
  1. Sensory Motor Recovery of the upper limb [ Time Frame: 20 minutes ]
    upper limb impairment assessment will be assessed by the Fugl-Meyer Assessment. This is the gold-standard assessment for upper limb motor ability in stroke patients. It comprises of 33 items.

  2. The amount of use of the upper extremity in everyday life [ Time Frame: 15 minutes ]
    The Motor Activity Log: a questionnaire consist of items regarding the use of the affected arm in every day tasks


Secondary Outcome Measures :
  1. index of curvature [ Time Frame: 30 minutes ]
    The ratio between a straight line and the path of the movement the participant did.

  2. stroke impact scale [ Time Frame: 30 minutes ]
    questionnaire regarding the effect of stroke on different aspects of life such as motor, cognitive, emotional and communication


Other Outcome Measures:
  1. Perceived Competence (Exercising Regularly) questionnaire [ Time Frame: 5 minutes ]
    4 items scale regarding the motivation of a person to exercise.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. First unilateral stroke (ischemic or hemorrhagic)
  2. Mini-Mental State Examination (MMSE) score ≥ 24/30
  3. Fugl-Meyer Upper Extremity (FM-UE) score 16-66
  4. Upper limb muscle tone assessed by Modified Ashworth Scale ≤ 2
  5. Ability of the participant to sit independently without external support. -

Exclusion Criteria:

  1. Additional neurological or musculoskeletal problems (such as Parkinson's disease, unilateral neglect, Pusher syndrome and apraxia).
  2. Severe vision or sensory deficits affecting upper limb movements.
  3. Aphasia affecting understanding of simple instructions.

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): NCT03651063


Contacts
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Contact: Shelly Levy-Tzedek, PhD 97286479560 shelly@bgu.ac.il
Contact: Ronit Feingold-Polak, MSc polakr@post.bgu.ac.il

Locations
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Israel
Aleh Negev Rehabilitation Center Recruiting
Ofakim, South, Israel
Contact: Oren Barzel, MD         
Sponsors and Collaborators
Ben-Gurion University of the Negev
Investigators
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Study Chair: Shelly Levy-Tzedek, PhD Ben-Gurion University of the Negev

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Responsible Party: Shelly Levy-Tzedek, Assistant Professor, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT03651063     History of Changes
Other Study ID Numbers: 5273-18-SMC
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shelly Levy-Tzedek, Ben-Gurion University of the Negev:
rehabilitation; social robots
Additional relevant MeSH terms:
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Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms