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StrokeNCT05007002

Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke

A study testing Robot-based therapy in people with Stroke, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Robot-based therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBelgium
Study dates
14 Jul 2021to 13 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • History of previous stroke or TIA
  • Any serious musculoskeletal and/or other neurological conditions
  • Serious communication or cognitive deficits
  • No written informed consent

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • KU Leuven

    Leuven, 3001

Other trials in Belgium

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
Robot-based therapy
Keywords
Stroke, Upper limb, Somatosensation, Sensory processing, Proprioception, Robot-based therapy, Robot-based assessment
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-based therapyDevice

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

Study groups in NCT05007002
Study groupRoleWhat they receive
Robot-based therapyExperimentalChronic stroke patients receiving robot-based therapy
Receives: Device: Robot-based therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinarm: sensory processing task

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

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

Secondary outcomes (15)

  1. Kinarm: arm position matching task

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

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

  2. Kinarm: arm movement matching task

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

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

  3. Kinarm: visually guided reaching task

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

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

  4. 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.

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

  5. 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

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

  6. Tactile discrimination test

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

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

  7. 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

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

  8. 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

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

  9. 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

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

  10. 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

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

  11. Montreal cognitive assessment

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

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

  12. 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

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

  13. Kinarm: sensory processing task

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

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

  14. Kinarm: sensory processing task

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

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

  15. Kinarm: sensory processing task

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start14 Jul 2021
  3. Primary completion13 Jun 2022
  4. Study completion13 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007002
Sponsor's protocol ID
S61997[2]
Status last verified
Jul 2022
First submitted
11 Jul 2021
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Saenen L, De Bruyn N, Verheyden G. Validity of a sensorimotor adaptation of the Action Research Arm Test (sARAT) in chronic stroke. Disabil Rehabil. 2024 Sep;46(19):4532-4539. doi: 10.1080/09638288.2023.2271837. Epub 2023 Oct 23.

    PubMed 37872776

Questions about this trial

What is this clinical trial studying?

A study testing Robot-based therapy in people with Stroke, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinarm: sensory processing task (time frame: Change during 4 weeks of therapy provided at least 6 months after stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007002, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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