Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke

Study Overview
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Brief Summary
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After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. Current evidence on treatment of upper limb sensory impairments is scarce and shows unclear results. Robot-based therapy has been increasingly used to treat upper limb motor impairments, with similar positive results as compared to conventional therapy. This study aims to investigate a novel robot-based therapy program for treatment of upper limb sensory impairments. The therapy program consists of 10 one-hour session spread over 4 weeks and will be evaluated for its effect in 20 chronic stroke patients. The investigators hypothesize that a 4-week robot-based therapy program can improve upper limb sensation and movement.

Detailed Description
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Up to 70% of stroke survivors show upper limb impairments consisting of motor and/or somatosensory impairments. These impairments often persist well into the chronic stage, and may lead to significant limitations in activities of daily living and may negatively affect quality of life. Different interventions have been investigated to treat upper limb motor impairments, including robot-based therapy, which shows similar positive results as compared to conventional therapy. Evidence on interventions for somatosensory impairments is scarce and often of low quality. This study therefore aims to evaluate the effect of a robot-based therapy program on sensorimotor function of the upper limb in a group of 20 chronic stroke patients. The robot-based therapy will be provided using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada) and consists of passive and active therapy tasks for proprioception and sensory processing. The therapy consists of 10 one-hour sessions spread over 4 weeks. Clinical and robot-based motor and somatosensory assessments will be performed at 4 time points: twice at baseline, once at mid intervention, and once after 10 hours of therapy. The investigators hypothesize to find improvement in both upper limb motor and somatosensory function after the therapy program. The results from this pilot study will provide a basis for further research.

Official Title
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Robot-based Therapy for Upper Limb Sensorimotor Impairments in the Chronic Phase After Stroke: a Pilot Study

Conditions
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Stroke

Intervention / Treatment
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* Device: Robot-based therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old A first-ever unilateral, supratentorial stroke (as defined by WHO) In the chronic phase after stroke (i.e. being at least 6 months after stroke) Motor deficits of the upper limb (Fugl-Meyer Motor Assessment - Upper Extremity < 60/66) Somatosensory deficits of the upper limb (Erasmus modified Nottingham Sensory Assessment < 36/40) Ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity Ability to perform passive and active sensory processing assessment task (primary outcome measure) Exclusion Criteria: History of previous stroke or TIA Any serious musculoskeletal and/or other neurological conditions Serious communication or cognitive deficits No written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-based therapy<br>Chronic stroke patients receiving robot-based therapy | Device: Robot-based therapy<br>* Active and passive therapy tasks for proprioception and sensory processing, with use of the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinarm: sensory processing task | Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing | Change during 4 weeks of therapy provided at least 6 months after stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinarm: arm position matching task | Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm Exoskeleton Lab | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Kinarm: arm movement matching task | Assessment of limb movement sense using a mirror-matching task on the Kinarm Exoskeleton Lab | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Kinarm: visually guided reaching task | Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Kinarm: working memory task | Assessment of working memory on the Kinarm End-Point Lab, by asking the participant to remember the position of 3, 4, 5 or 6 targets simultaneously. | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Erasmus modified Nottingham sensory assessment | Clinical assessment of somatosensory function (including exteroception, proprioception and sensory processing) on an ordinal scale ranging from 0 to 40, with higher scores meaning better performance | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Tactile discrimination test | Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Functional tactile object recognition test | Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 42, with higher scores meaning better performance | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Fugl-Meyer upper extremity assessment | Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Action research arm test | Timed clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Sensorimotor action research arm test | Timed clinical assessment of sensorimotor performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Montreal cognitive assessment | Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Star cancellation test | Clinical assessment of visuospatial neglect on an ordinal scale ranging from 0 to 54, with higher scores meaning better performance, and a score below 44 indicating the presence of visuospatial neglect | Change during 4 weeks of therapy provided at least 6 months after stroke | 
| Kinarm: sensory processing task | Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing | Change in 2 baseline measures taken 2 days apart, at least 6 months after stroke | 
| Kinarm: sensory processing task | Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing | Change during the first 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke | 
| Kinarm: sensory processing task | Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing | Change during the last 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Upper limb, Somatosensation, Sensory processing, Proprioception, Robot-based therapy, Robot-based assessment