Clinical trial NCT02096445: Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
Official title: Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: stroke
acute
rehabilitation
robot therapy
hand function
fine motor skills
neurocognitive
sensory
Perfetti
haptics
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Motor impairment of the upper limb
timeFrame: Change from Baseline in motor impairment of the upper limb at 4 weeks
Secondary outcomes:
measure: Motor impairment of the upper limb
timeFrame: Change from Baseline in motor impairment of the upper limb at 8 weeks
measure: Motor impairment of the upper limb
timeFrame: Change from Baseline in motor impairment of the upper limb at 6 months
measure: Functional improvement in dexterity
timeFrame: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
measure: Functional improvement in dexterity
timeFrame: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
measure: Functional improvement in dexterity
timeFrame: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
measure: Spasticity level of the upper limb
timeFrame: Change from Baseline in spasticity level of the upper limb at 4 weeks
measure: Spasticity level of the upper limb
timeFrame: Change from Baseline in spasticity level of the upper limb at 8 weeks
measure: Spasticity level of the upper limb
timeFrame: Change from Baseline in spasticity level of the upper limb at 6 months
measure: Tactile and proprioceptive sensory function of the upper limb
timeFrame: Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
measure: Tactile and proprioceptive sensory function of the upper limb
timeFrame: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
measure: Tactile and proprioceptive sensory function of the upper limb
timeFrame: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
measure: Neglect
timeFrame: Change from Baseline in neglect at 4 weeks
measure: Neglect
timeFrame: Change from Baseline in neglect at 8 weeks
measure: Neglect
timeFrame: Change from Baseline in neglect at 6 months
measure: Cognitive impairment
timeFrame: Change from Baseline in cognitive impairment at 4 weeks
measure: Cognitive impairment
timeFrame: Change from Baseline in cognitive impairment at 8 weeks
measure: Cognitive impairment
timeFrame: Change from Baseline in cognitive impairment at 6 months
measure: Frontal lobe function
timeFrame: Change from Baseline in frontal lobe function at 4 weeks
measure: Frontal lobe function
timeFrame: Change from Baseline in frontal lobe function at 8 weeks
measure: Frontal lobe function
timeFrame: Change from Baseline in frontal lobe function at 6 months
measure: Aphasia
timeFrame: Change from Baseline in aphasia at 4 weeks
measure: Aphasia
timeFrame: Change from Baseline in aphasia at 8 weeks
measure: Aphasia
timeFrame: Change from Baseline in aphasia at 6 months
measure: Attention
timeFrame: Change from Baseline in attention at 4 weeks
measure: Attention
timeFrame: Change from Baseline in attention at 8 weeks
measure: Attention
timeFrame: Change from Baseline in attention at 6 months
Other outcomes:
Locations:
city: Brissago
country: Switzerland
facility: Clinica Hildebrand Centro di riabilitazione Brissago
state: Ticino
Study officials:
affiliation: Rehabilitation Engineering Lab, ETH Zurich
name: Roger Gassert, Prof. Dr.
role: STUDY_DIRECTOR
References:
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.
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.
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.