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Trial record 1 of 1 for:    NCT02096445
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Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

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ClinicalTrials.gov Identifier: NCT02096445
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Roger Gassert, Swiss Federal Institute of Technology

Brief Summary:
The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.

Condition or disease Intervention/treatment Phase
Stroke Upper Extremity Paresis Device: robot-assisted neurocognitive therapy of hand function Other: Conventional neurocognitive rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
Actual Study Start Date : April 2013
Actual Primary Completion Date : March 10, 2017
Actual Study Completion Date : June 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Robot group

Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy.

(4 x 45 min/week)

Device: robot-assisted neurocognitive therapy of hand function
2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
Other Name: Rehabilitation robot ReHapticKnob

Active Comparator: Control group
Receive dose-matched conventional neurocognitive therapy
Other: Conventional neurocognitive rehabilitation
Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g. discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
Other Name: Perfetti-concept




Primary Outcome Measures :
  1. Motor impairment of the upper limb [ Time Frame: Change from Baseline in motor impairment of the upper limb at 4 weeks ]
    Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)


Secondary Outcome Measures :
  1. Motor impairment of the upper limb [ Time Frame: Change from Baseline in motor impairment of the upper limb at 8 weeks ]
    Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)

  2. Motor impairment of the upper limb [ Time Frame: Change from Baseline in motor impairment of the upper limb at 6 months ]
    Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)

  3. Functional improvement in dexterity [ Time Frame: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks ]
    Functional improvement in dexterity is assessed with the Box and Block Test

  4. Functional improvement in dexterity [ Time Frame: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks ]
    Functional improvement in dexterity is assessed with the Box and Block Test

  5. Functional improvement in dexterity [ Time Frame: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months ]
    Functional improvement in dexterity is assessed with the Box and Block Test

  6. Spasticity level of the upper limb [ Time Frame: Change from Baseline in spasticity level of the upper limb at 4 weeks ]
    Spasticity level is measured with the Modified Ashworth Scale

  7. Spasticity level of the upper limb [ Time Frame: Change from Baseline in spasticity level of the upper limb at 8 weeks ]
    Spasticity level is measured with the Modified Ashworth Scale

  8. Spasticity level of the upper limb [ Time Frame: Change from Baseline in spasticity level of the upper limb at 6 months ]
    Spasticity level is measured with the Modified Ashworth Scale

  9. Tactile and proprioceptive sensory function of the upper limb [ Time Frame: Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks ]
    Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment

  10. Tactile and proprioceptive sensory function of the upper limb [ Time Frame: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks ]
    Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment

  11. Tactile and proprioceptive sensory function of the upper limb [ Time Frame: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months ]
    Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment

  12. Neglect [ Time Frame: Change from Baseline in neglect at 4 weeks ]
    Neglect is assessed with the Albert's test of neglect

  13. Neglect [ Time Frame: Change from Baseline in neglect at 8 weeks ]
    Neglect is assessed with the Albert's test of neglect

  14. Neglect [ Time Frame: Change from Baseline in neglect at 6 months ]
    Neglect is assessed with the Albert's test of neglect

  15. Cognitive impairment [ Time Frame: Change from Baseline in cognitive impairment at 4 weeks ]
    Cognitive impairment is assessed with the Mini Mental State Examination

  16. Cognitive impairment [ Time Frame: Change from Baseline in cognitive impairment at 8 weeks ]
    Cognitive impairment is assessed with the Mini Mental State Examination

  17. Cognitive impairment [ Time Frame: Change from Baseline in cognitive impairment at 6 months ]
    Cognitive impairment is assessed with the Mini Mental State Examination

  18. Frontal lobe function [ Time Frame: Change from Baseline in frontal lobe function at 4 weeks ]
    Frontal lobe function is assessed with the Frontal assessment battery

  19. Frontal lobe function [ Time Frame: Change from Baseline in frontal lobe function at 8 weeks ]
    Frontal lobe function is assessed with the Frontal assessment battery

  20. Frontal lobe function [ Time Frame: Change from Baseline in frontal lobe function at 6 months ]
    Frontal lobe function is assessed with the Frontal assessment battery

  21. Aphasia [ Time Frame: Change from Baseline in aphasia at 4 weeks ]
    Aphasia is assessed with the Aachener Aphasia Test

  22. Aphasia [ Time Frame: Change from Baseline in aphasia at 8 weeks ]
    Aphasia is assessed with the Aachener Aphasia Test

  23. Aphasia [ Time Frame: Change from Baseline in aphasia at 6 months ]
    Aphasia is assessed with the Aachener Aphasia Test

  24. Attention [ Time Frame: Change from Baseline in attention at 4 weeks ]
    Attention is assessed with the test to identify attention

  25. Attention [ Time Frame: Change from Baseline in attention at 8 weeks ]
    Attention is assessed with the test to identify attention

  26. Attention [ Time Frame: Change from Baseline in attention at 6 months ]
    Attention is assessed with the test to identify attention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18-90 years old
  • hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
  • sub-acute lesion not more than 6 weeks post ictus

Exclusion Criteria:

  • insufficient state of consciousness
  • severe aphasia
  • severe cognitive deficits
  • severe pathologies of the upper extremity of traumatic or rheumatic nature
  • severe pain in the affected arm
  • Patients with pacemakers and other active implants

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): NCT02096445


Locations
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Switzerland
Clinica Hildebrand Centro di riabilitazione Brissago
Brissago, Ticino, Switzerland, 6614
Sponsors and Collaborators
Roger Gassert
Investigators
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Study Director: Roger Gassert, Prof. Dr. Rehabilitation Engineering Lab, ETH Zurich

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roger Gassert, Prof. Dr., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02096445    
Other Study ID Numbers: CIV-13-02-009921
2013-MD-0002 ( Other Identifier: Swissmedic )
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Keywords provided by Roger Gassert, Swiss Federal Institute of Technology:
stroke
acute
rehabilitation
robot therapy
hand function
fine motor skills
neurocognitive
sensory
Perfetti
haptics
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms