Towards Understanding Upper Limb Rehabilitation After Stroke

Stroke Clinical Trial

Official title:

Robotic Assessment of Upper Limb Passive and Active Sensory Processing in the Chronic Phase After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721561
• Other study ID #: S61997
• Secondary ID: C22/18/008
• Status: Completed
• Start date: December 18, 2019
• Est. completion date: December 22, 2020

Study information

• Verified date: March 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. During the past decade, robotic technology has been increasingly used to asses these problems in a detailed and accurate manner. However, sensory processing, one of the most important sensory functions, has not been assessed using robotic technology yet. Therefore, the investigators have developed a robotic assessment of sensory processing. During this study, the investigators aim to initially validate this novel assessment. The investigators aim to examine 20 chronic stroke patients and 20 age-matched healthy controls using the robotic assessment on one hand, and a set of existing clinical assessments on the other hand. The investigators hypothesize that stroke patients will have a poorer performance on this novel robotic assessment compared to age-matched healthy controls, and that these findings are similar to what is found with existing clinical assessments.

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. It is therefore of utmost importance to accurately assess upper limb impairments. Clinical assessments exist for both motor and somatosensory function, but lack good psychometric properties. Robotic technology show promising potential and is readily available to assess motor function and proprioception. Robotic assessment for sensory processing is currently not yet available, despite being the most relevant somatosensory function. Indeed, sensory processing shows the strongest association with upper limb movement, and only shows incomplete recovery at 6 months after stroke.

The investigators recently developed a novel robotic assessment of sensory processing, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). This cross-sectional study was set up to initially validate this novel robotic assessment and to collect pilot data to form the basis for future research. 20 chronic stroke patients and 20 age-matched controls will be recruited and will undergo extensive clinical and robotic assessment of upper limb motor and somatosensory function. The investigators hypothesize stoke patients with sensory processing deficits to have a worse performance on this novel robotic assessment compared to healthy controls and patients without sensory processing deficits. The investigators also hypothesize to see moderate to high correlations between the robotic assessment of sensory processing, and clinical assessments for both somatosensory and motor function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria - Stroke Patients:

• 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)

• The ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity

Exclusion Criteria - Stroke Patients:

• Any serious musculoskeletal and/or other neurological conditions

• Serious communication or cognitive deficits

• No written informed consent

Inclusion Criteria - Healthy Controls:

• At least 18 years old

Exclusion Criteria - Healthy Controls:

• History of stroke or TIA

• Upper limb somatosensory and/or motor impairments

• Any serious musculoskeletal and/or other neurological conditions

• Serious communication or cognitive deficits

• No written informed consent

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinarm: sensory processing task	Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing	Once in the chronic phase (at least 6 months after stroke)
Secondary	Kinarm: position matching task	Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab	Once in the chronic phase (at least 6 months after stroke)
Secondary	Kinarm: visually guided reaching	Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab	Once in the chronic phase (at least 6 months after stroke)
Secondary	Erasmus modified Nottingham sensory assessment	Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	Tactile discrimination test	Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	Tactile functional object recognition	Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 42, with higher scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	Stereognosis section of the original Nottingham sensory assessment	Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 22, with higher scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	Wrist position sense test	Clinical assessment of wrist position sense on a continuous scale, with lower scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	Perceptual threshold of touch	TENS-based assessment of exteroception on a continuous scale, with lower scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	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	Once in the chronic phase (at least 6 months after stroke)
Secondary	Action research arm test	Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	Barthel index	Clinical assessment of activities of daily living on an ordinal scale ranging from 0 to 20, with higher scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	Montreal cognitive assessment	Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance	Once in the chronic phase (at least 6 months after stroke)
Secondary	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	Once in the chronic phase (at least 6 months after stroke)