Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Stroke Clinical Trial

Official title:

Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096445
• Other study ID #: CIV-13-02-009921
• Secondary ID: 2013-MD-0002
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: June 9, 2017
• Start date: April 2013
• Est. completion date: June 9, 2017

Study information

• Verified date: June 2017
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 9, 2017
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Paresis
• Stroke
• Upper Extremity Paresis

Intervention

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:
• 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.

Locations

Country	Name	City	State
Switzerland	Clinica Hildebrand Centro di riabilitazione Brissago	Brissago	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Roger Gassert

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Change from Baseline in motor impairment of the upper limb at 4 weeks
Secondary	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)	Change from Baseline in motor impairment of the upper limb at 8 weeks
Secondary	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)	Change from Baseline in motor impairment of the upper limb at 6 months
Secondary	Functional improvement in dexterity	Functional improvement in dexterity is assessed with the Box and Block Test	Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Secondary	Functional improvement in dexterity	Functional improvement in dexterity is assessed with the Box and Block Test	Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Secondary	Functional improvement in dexterity	Functional improvement in dexterity is assessed with the Box and Block Test	Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Secondary	Spasticity level of the upper limb	Spasticity level is measured with the Modified Ashworth Scale	Change from Baseline in spasticity level of the upper limb at 4 weeks
Secondary	Spasticity level of the upper limb	Spasticity level is measured with the Modified Ashworth Scale	Change from Baseline in spasticity level of the upper limb at 8 weeks
Secondary	Spasticity level of the upper limb	Spasticity level is measured with the Modified Ashworth Scale	Change from Baseline in spasticity level of the upper limb at 6 months
Secondary	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	Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Secondary	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	Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Secondary	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	Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Secondary	Neglect	Neglect is assessed with the Albert's test of neglect	Change from Baseline in neglect at 4 weeks
Secondary	Neglect	Neglect is assessed with the Albert's test of neglect	Change from Baseline in neglect at 8 weeks
Secondary	Neglect	Neglect is assessed with the Albert's test of neglect	Change from Baseline in neglect at 6 months
Secondary	Cognitive impairment	Cognitive impairment is assessed with the Mini Mental State Examination	Change from Baseline in cognitive impairment at 4 weeks
Secondary	Cognitive impairment	Cognitive impairment is assessed with the Mini Mental State Examination	Change from Baseline in cognitive impairment at 8 weeks
Secondary	Cognitive impairment	Cognitive impairment is assessed with the Mini Mental State Examination	Change from Baseline in cognitive impairment at 6 months
Secondary	Frontal lobe function	Frontal lobe function is assessed with the Frontal assessment battery	Change from Baseline in frontal lobe function at 4 weeks
Secondary	Frontal lobe function	Frontal lobe function is assessed with the Frontal assessment battery	Change from Baseline in frontal lobe function at 8 weeks
Secondary	Frontal lobe function	Frontal lobe function is assessed with the Frontal assessment battery	Change from Baseline in frontal lobe function at 6 months
Secondary	Aphasia	Aphasia is assessed with the Aachener Aphasia Test	Change from Baseline in aphasia at 4 weeks
Secondary	Aphasia	Aphasia is assessed with the Aachener Aphasia Test	Change from Baseline in aphasia at 8 weeks
Secondary	Aphasia	Aphasia is assessed with the Aachener Aphasia Test	Change from Baseline in aphasia at 6 months
Secondary	Attention	Attention is assessed with the test to identify attention	Change from Baseline in attention at 4 weeks
Secondary	Attention	Attention is assessed with the test to identify attention	Change from Baseline in attention at 8 weeks
Secondary	Attention	Attention is assessed with the test to identify attention	Change from Baseline in attention at 6 months

External Links

•   Homepage of the investigator's laboratory