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Completed

NCT Number: NCT05007002

Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, 3001, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-based therapy

Device

Active and passive therapy tasks for proprioception and sensory processing, with use of the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada)

Primary outcomes

  1. Kinarm: sensory processing task

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

Secondary outcomes

  1. Kinarm: arm position matching task

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm Exoskeleton Lab

  2. Kinarm: arm movement matching task

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Assessment of limb movement sense using a mirror-matching task on the Kinarm Exoskeleton Lab

  3. Kinarm: visually guided reaching task

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab

  4. Kinarm: working memory task

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    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.

  5. Erasmus modified Nottingham sensory assessment

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    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

  6. Tactile discrimination test

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance

  7. Functional tactile object recognition test

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 42, with higher scores meaning better performance

  8. Fugl-Meyer upper extremity assessment

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance

  9. Action research arm test

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Timed clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance

  10. Sensorimotor action research arm test

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Timed clinical assessment of sensorimotor performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance

  11. Montreal cognitive assessment

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance

  12. Star cancellation test

    Time frame: Change during 4 weeks of therapy provided at least 6 months after stroke

    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

  13. Kinarm: sensory processing task

    Time frame: Change in 2 baseline measures taken 2 days apart, at least 6 months after stroke

    Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

  14. Kinarm: sensory processing task

    Time frame: Change during the first 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke

    Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

  15. Kinarm: sensory processing task

    Time frame: Change during the last 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke

    Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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