Clinical trial NCT05007002: Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke
Official title: Robot-based Therapy for Upper Limb Sensorimotor Impairments in the Chronic Phase After Stroke: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Upper limb
Somatosensation
Sensory processing
Proprioception
Robot-based therapy
Robot-based assessment
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2021-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Kinarm: sensory processing task
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary outcomes:
measure: Kinarm: arm position matching task
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Kinarm: arm movement matching task
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Kinarm: visually guided reaching task
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Kinarm: working memory task
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Erasmus modified Nottingham sensory assessment
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Tactile discrimination test
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Functional tactile object recognition test
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Fugl-Meyer upper extremity assessment
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Action research arm test
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Sensorimotor action research arm test
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Montreal cognitive assessment
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Star cancellation test
timeFrame: Change during 4 weeks of therapy provided at least 6 months after stroke
measure: Kinarm: sensory processing task
timeFrame: Change in 2 baseline measures taken 2 days apart, at least 6 months after stroke
measure: Kinarm: sensory processing task
timeFrame: Change during the first 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke
measure: Kinarm: sensory processing task
timeFrame: Change during the last 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References: