Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke

NCT ID: NCT05007002

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2022-06-13

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot-based therapy

Chronic stroke patients receiving robot-based therapy

Group Type: EXPERIMENTAL

Robot-based therapy

Intervention Type: DEVICE

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

Interventions

Robot-based therapy

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Geert Verheyden

Professor Neurorehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S61997[2]

Identifier Type: -

Identifier Source: org_study_id