Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007002
• Other study ID #: S61997[2]
• Status: Completed
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: July 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen 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	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	Kinarm: arm position matching task	Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm Exoskeleton Lab	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	Kinarm: arm movement matching task	Assessment of limb movement sense using a mirror-matching task on the Kinarm Exoskeleton Lab	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	Kinarm: visually guided reaching task	Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	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.	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	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	Change during 4 weeks of therapy provided 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	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	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	Change during 4 weeks of therapy provided 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	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	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	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	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	Change during 4 weeks of therapy provided 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	Change during 4 weeks of therapy provided 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	Change during 4 weeks of therapy provided at least 6 months after stroke
Secondary	Kinarm: sensory processing task	Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing	Change in 2 baseline measures taken 2 days apart, at least 6 months after stroke
Secondary	Kinarm: sensory processing task	Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing	Change during the first 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke
Secondary	Kinarm: sensory processing task	Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing	Change during the last 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke