Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
Primary Purpose
Stroke, Upper Extremity Paresis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
robot-assisted neurocognitive therapy of hand function
Conventional neurocognitive rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, acute, rehabilitation, robot therapy, hand function, fine motor skills, neurocognitive, sensory, Perfetti, haptics
Eligibility 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
Sites / Locations
- Clinica Hildebrand Centro di riabilitazione Brissago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot group
Control group
Arm Description
Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week)
Receive dose-matched conventional neurocognitive therapy
Outcomes
Primary Outcome Measures
Motor impairment of the upper limb
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
Motor impairment of the upper limb
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)
Motor impairment of the upper limb
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)
Functional improvement in dexterity
Functional improvement in dexterity is assessed with the Box and Block Test
Functional improvement in dexterity
Functional improvement in dexterity is assessed with the Box and Block Test
Functional improvement in dexterity
Functional improvement in dexterity is assessed with the Box and Block Test
Spasticity level of the upper limb
Spasticity level is measured with the Modified Ashworth Scale
Spasticity level of the upper limb
Spasticity level is measured with the Modified Ashworth Scale
Spasticity level of the upper limb
Spasticity level is measured with the Modified Ashworth Scale
Tactile and proprioceptive sensory function of the upper limb
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
Tactile and proprioceptive sensory function of the upper limb
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Tactile and proprioceptive sensory function of the upper limb
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Neglect
Neglect is assessed with the Albert's test of neglect
Neglect
Neglect is assessed with the Albert's test of neglect
Neglect
Neglect is assessed with the Albert's test of neglect
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Attention
Attention is assessed with the test to identify attention
Attention
Attention is assessed with the test to identify attention
Attention
Attention is assessed with the test to identify attention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02096445
Brief Title
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
Official Title
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
March 10, 2017 (Actual)
Study Completion Date
June 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roger Gassert
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis
Keywords
stroke, acute, rehabilitation, robot therapy, hand function, fine motor skills, neurocognitive, sensory, Perfetti, haptics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot group
Arm Type
Experimental
Arm Description
Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy.
(4 x 45 min/week)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Receive dose-matched conventional neurocognitive therapy
Intervention Type
Device
Intervention Name(s)
robot-assisted neurocognitive therapy of hand function
Other Intervention Name(s)
Rehabilitation robot ReHapticKnob
Intervention Description
2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
Intervention Type
Other
Intervention Name(s)
Conventional neurocognitive rehabilitation
Other Intervention Name(s)
Perfetti-concept
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor impairment of the upper limb
Description
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)
Time Frame
Change from Baseline in motor impairment of the upper limb at 4 weeks
Secondary Outcome Measure Information:
Title
Motor impairment of the upper limb
Description
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)
Time Frame
Change from Baseline in motor impairment of the upper limb at 8 weeks
Title
Motor impairment of the upper limb
Description
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)
Time Frame
Change from Baseline in motor impairment of the upper limb at 6 months
Title
Functional improvement in dexterity
Description
Functional improvement in dexterity is assessed with the Box and Block Test
Time Frame
Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Title
Functional improvement in dexterity
Description
Functional improvement in dexterity is assessed with the Box and Block Test
Time Frame
Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Title
Functional improvement in dexterity
Description
Functional improvement in dexterity is assessed with the Box and Block Test
Time Frame
Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Title
Spasticity level of the upper limb
Description
Spasticity level is measured with the Modified Ashworth Scale
Time Frame
Change from Baseline in spasticity level of the upper limb at 4 weeks
Title
Spasticity level of the upper limb
Description
Spasticity level is measured with the Modified Ashworth Scale
Time Frame
Change from Baseline in spasticity level of the upper limb at 8 weeks
Title
Spasticity level of the upper limb
Description
Spasticity level is measured with the Modified Ashworth Scale
Time Frame
Change from Baseline in spasticity level of the upper limb at 6 months
Title
Tactile and proprioceptive sensory function of the upper limb
Description
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
Time Frame
Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Title
Tactile and proprioceptive sensory function of the upper limb
Description
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Time Frame
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Title
Tactile and proprioceptive sensory function of the upper limb
Description
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Time Frame
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Title
Neglect
Description
Neglect is assessed with the Albert's test of neglect
Time Frame
Change from Baseline in neglect at 4 weeks
Title
Neglect
Description
Neglect is assessed with the Albert's test of neglect
Time Frame
Change from Baseline in neglect at 8 weeks
Title
Neglect
Description
Neglect is assessed with the Albert's test of neglect
Time Frame
Change from Baseline in neglect at 6 months
Title
Cognitive impairment
Description
Cognitive impairment is assessed with the Mini Mental State Examination
Time Frame
Change from Baseline in cognitive impairment at 4 weeks
Title
Cognitive impairment
Description
Cognitive impairment is assessed with the Mini Mental State Examination
Time Frame
Change from Baseline in cognitive impairment at 8 weeks
Title
Cognitive impairment
Description
Cognitive impairment is assessed with the Mini Mental State Examination
Time Frame
Change from Baseline in cognitive impairment at 6 months
Title
Frontal lobe function
Description
Frontal lobe function is assessed with the Frontal assessment battery
Time Frame
Change from Baseline in frontal lobe function at 4 weeks
Title
Frontal lobe function
Description
Frontal lobe function is assessed with the Frontal assessment battery
Time Frame
Change from Baseline in frontal lobe function at 8 weeks
Title
Frontal lobe function
Description
Frontal lobe function is assessed with the Frontal assessment battery
Time Frame
Change from Baseline in frontal lobe function at 6 months
Title
Aphasia
Description
Aphasia is assessed with the Aachener Aphasia Test
Time Frame
Change from Baseline in aphasia at 4 weeks
Title
Aphasia
Description
Aphasia is assessed with the Aachener Aphasia Test
Time Frame
Change from Baseline in aphasia at 8 weeks
Title
Aphasia
Description
Aphasia is assessed with the Aachener Aphasia Test
Time Frame
Change from Baseline in aphasia at 6 months
Title
Attention
Description
Attention is assessed with the test to identify attention
Time Frame
Change from Baseline in attention at 4 weeks
Title
Attention
Description
Attention is assessed with the test to identify attention
Time Frame
Change from Baseline in attention at 8 weeks
Title
Attention
Description
Attention is assessed with the test to identify attention
Time Frame
Change from Baseline in attention at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Gassert, Prof. Dr.
Organizational Affiliation
Rehabilitation Engineering Lab, ETH Zurich
Official's Role
Study Director
Facility Information:
Facility Name
Clinica Hildebrand Centro di riabilitazione Brissago
City
Brissago
State/Province
Ticino
ZIP/Postal Code
6614
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24968378
Citation
Metzger JC, Lambercy O, Califfi A, Conti FM, Gassert R. Neurocognitive robot-assisted therapy of hand function. IEEE Trans Haptics. 2014 Apr-Jun;7(2):140-9. doi: 10.1109/TOH.2013.72.
Results Reference
result
PubMed Identifier
32831097
Citation
Ranzani R, Lambercy O, Metzger JC, Califfi A, Regazzi S, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke. J Neuroeng Rehabil. 2020 Aug 24;17(1):115. doi: 10.1186/s12984-020-00746-7.
Results Reference
derived
PubMed Identifier
25399249
Citation
Metzger JC, Lambercy O, Califfi A, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Assessment-driven selection and adaptation of exercise difficulty in robot-assisted therapy: a pilot study with a hand rehabilitation robot. J Neuroeng Rehabil. 2014 Nov 15;11:154. doi: 10.1186/1743-0003-11-154.
Results Reference
derived
Links:
URL
http://www.relab.ethz.ch
Description
Homepage of the investigator's laboratory
Learn more about this trial
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
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