An interventional study of Robot-based therapy in Stroke, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by KU Leuven · Not applicable, Interventional, and Treatment
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →KU Leuven is the lead sponsor of 371 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
Chronic stroke patients receiving robot-based therapy
Device: Robot-based therapy
Active and passive therapy tasks for proprioception and sensory processing, with use of the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada)
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke
Kinarm: arm position matching task
Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm Exoskeleton Lab
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change during the last 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke
Plan to share: Undecided
Ran from Jul 2021 to primary completion in Jun 2022, 10 months.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 10 months is below that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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