Towards Understanding Upper Limb Rehabilitation After Stroke

NCT ID: NCT04721561

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2020-12-22

Brief 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.

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. 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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic stroke patients

Patients who are at least 6 months after a first unilateral stroke

No interventions assigned to this group

Healthy controls

Healthy subjects with no history of any neurological condition and who are in the same age group as the chronic stroke patients

No interventions assigned to this group

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

• At least 18 years old

Exclusion Criteria

• Any serious musculoskeletal and/or other neurological conditions
• Serious communication or cognitive deficits
• No written informed consent

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Geert Verheyden

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geert Verheyden

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

C22/18/008

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S61997

Identifier Type: -

Identifier Source: org_study_id