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Completed

NCT Number: NCT02096445

Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Paresis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Hildebrand Centro di riabilitazione Brissago

Brissago, Canton Ticino, 6614, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

robot-assisted neurocognitive therapy of hand function

Device

2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.

Other names: Rehabilitation robot ReHapticKnob

Conventional neurocognitive rehabilitation

Other

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 names: Perfetti-concept

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Roger Gassert

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2014
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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