Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Robot-based therapy
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Upper limb, Somatosensation, Sensory processing, Proprioception, Robot-based therapy, Robot-based assessment
Eligibility Criteria
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
Sites / Locations
- KU Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot-based therapy
Arm Description
Chronic stroke patients receiving robot-based therapy
Outcomes
Primary Outcome Measures
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Secondary Outcome Measures
Kinarm: arm position matching task
Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm Exoskeleton Lab
Kinarm: arm movement matching task
Assessment of limb movement sense using a mirror-matching task on the Kinarm Exoskeleton Lab
Kinarm: visually guided reaching task
Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab
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.
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
Tactile discrimination test
Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance
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
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
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
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
Montreal cognitive assessment
Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance
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
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Full Information
NCT ID
NCT05007002
First Posted
July 11, 2021
Last Updated
July 19, 2022
Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05007002
Brief Title
Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke
Official Title
Robot-based Therapy for Upper Limb Sensorimotor Impairments in the Chronic Phase After Stroke: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Upper limb, Somatosensation, Sensory processing, Proprioception, Robot-based therapy, Robot-based assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot-based therapy
Arm Type
Experimental
Arm Description
Chronic stroke patients receiving robot-based therapy
Intervention Type
Device
Intervention Name(s)
Robot-based therapy
Intervention Description
Active and passive therapy tasks for proprioception and sensory processing, with use of the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada)
Primary Outcome Measure Information:
Title
Kinarm: sensory processing task
Description
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
Secondary Outcome Measure Information:
Title
Kinarm: arm position matching task
Description
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
Title
Kinarm: arm movement matching task
Description
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
Title
Kinarm: visually guided reaching task
Description
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
Title
Kinarm: working memory task
Description
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
Title
Erasmus modified Nottingham sensory assessment
Description
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
Title
Tactile discrimination test
Description
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
Title
Functional tactile object recognition test
Description
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
Title
Fugl-Meyer upper extremity assessment
Description
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
Title
Action research arm test
Description
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
Title
Sensorimotor action research arm test
Description
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
Title
Montreal cognitive assessment
Description
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
Title
Star cancellation test
Description
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
Title
Kinarm: sensory processing task
Description
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
Title
Kinarm: sensory processing task
Description
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
Title
Kinarm: sensory processing task
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3001
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke
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