Healthy Adult, Stroke
Conditions
Keywords
Stroke, Upper limb, Sensorimotor, Sensory processing, Robot-based therapy, MRI, fNIRS, Clinical outcomes, Kinematic outcomes
Brief summary
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (\>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.
Detailed description
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (\>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT. Within this RCT, the investigators will include participants with chronic stroke and healthy controls. The participants with stroke will be randomly divided in two groups: the experimental group and control group. The experimental group will receive an additional integrated treatment paradigm to their standard care. This novel integrated treatment (called ROBUST) is a combination of robot-based (Kinarm), conventional and home therapy. The control group will first receive their standard care alone, followed by an additional Kinarm therapy (one part of ROBUST) to their standard care. The healthy controls will also first receive no additional therapy, followed by the additional Kinarm therapy. After each control period (no extra therapy) and/or each intervention period (additional ROBUST or Kinarm therapy), a follow-up period is included whereby the participants just follow their standard care. The aim is to investigate the effects of the additional ROBUST rehabilitation, compared to the standard care, and compared to the additional Kinarm therapy. The investigators will investigate the differences in sensorimotor improvement induced by the additional Kinarm therapy between persons with stroke and healthy controls. Finally, the investigators will investigate the clinical and kinematic effectiveness, as well as potential changes in brain function (activity and connectivity) and structure.
Interventions
BEHAVIORALROBUST
During a 5-week intervention, participants in the stroke experimental group get 48 hours additional sensorimotor upper limb training. They will come 2-3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy (Kinarm therapy) and one hour transfer package training with a therapist. Additionally, they follow 4-5 times a week a 1-hour home program. This intervention can be distinguished from others since it integrates both motor and sensory function, with focus on sensory processing. It combines robot-based therapy, a transfer package to daily activities, and a home program.
BEHAVIORALKinarm therapy
During a 5-week intervention, participants in the stroke control group and the healthy control group get 12 hours additional Kinarm therapy (one part of the ROBUST intervention). They will come 2-3 times per week to Leuven for a one-hour therapy session. This robotic intervention can be distinguished from others since it integrates both motor and sensory function, with focus on sensory processing.
Sponsors
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
In this study, the investigators will include 58 chronic stroke participants and 51 healthy participants. The stroke participants will be randomized in a control group or experimental group. The outcome assessors are blinded for the stroke participants, but not for the healthy participants. The healthy participants will just be one control group, they will not be randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
stroke participants: 1. Written informed consent must be obtained prior to any screening procedures; 2. A first-ever unilateral, supra-tentorial stroke, as defined by WHO (rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than vascular origin); 3. ≥18 and ≤85 years old; 4. Being a Dutch speaker; 5. Being in the chronic phase after stroke, i.e. \> 6 months post stroke; 6. Motor impairment in the upper limb, defined as Fugl-Meyer score \>22 out of 66 to demonstrate moderate to full upper limb motor function (patients scoring \<23 out of 66 will not be able to comply with the Kinarm protocol); 7. Residual sensory upper limb impairment, defined as Tactile Discrimination Test (Area Under Curve) \<73.10%; 8. Impaired functionality, defined as sensorimotor Action Research Arm Test score \<52 out of 57; 9. Manageable spasticity for Kinarm tasks. Inclusion Criteria healthy participants: 1. Written informed consent must be obtained prior to any screening procedures; 2. ≥18 and ≤85 years old; 3. Being a Dutch or English speaker; 4. No history of stroke or transient ischemic attack; 5. No recent brain/head injury; 6. No major upper limb sensory or motor impairments.
Exclusion criteria
1. Having musculoskeletal and/or other neurological disorders impacting care or prognosis; 2. Having severe communication or cognitive deficits that interfere with the protocol; 3. Having severe spasticity (cannot handle Kinarm robot); 4. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP; 5. Contraindications for robot-based therapy (e.g., uncontrolled epilepsy); 6. Participation in another clinical investigation; 7. Having any contraindications for fNIRS\*： * Uncontrolled head movements (e.g. tremor) * Scalp lesion at optode sites (wound/incision/infection/hematoma) * Decompressive craniectomy or large skull defect over target regions * Persistent hair-optode coupling failure despite best practices, or non-removable obstructions preventing adequate coupling 8. Having any contraindications for MRI\*\*: * Pacemaker * Implantable Cardioverter Defibrillator (ICD) * Cochlear implant * Internal Insulin-pump * Deep brain stimulation * Any other metal device in the body * Claustrophobia * Having a history of a neuropsychiatric or neurologic disorder before the diagnosis of stroke (e.g., depression, traumatic brain injury) * Use of psychoactive medication before the diagnosis of stroke (e.g., anti-depressive medication) * Misuse (or history of misuse) of drugs/alcohol 9. Currently undergoing a structured arm and/or hand training (e.g. engaging in playing a musical instrument)\*\*. * Stroke patients and healthy participants showing these
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinarm: Visually Guided Reaching Task | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab |
| Kinarm: Arm Position Matching Task | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab. |
| Kinarm: Passive and Active Discrimination Task | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | Task on the Kinarm End-Point Lab used to assess passive and active sensory processing. |
| MRI assessment | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | MRI scan to study the structure and function of the brain, during rest and during a sensorimotor upper limb task. |
| Sensorimotor Action Research Arm Test | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | Clinical assessment of sensorimotor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance. |
| Fugl-Meyer Assessment for the upper extremity | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance. |
| Tactile Discrimination Test | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | Clinical assessment of sensory processing with an area under the curve based scoring system ranging from 0-100%, with higher scores meaning better performance. |
| Stroke Impact Scale | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | A self-report questionnaire that evaluates disability and health-related quality of life after stroke. Each category ranges from 0-100. A higher score indicates less disability and better quality of life. |
| fNIRS assessment | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | The patient will be fitted with the fNIRS head cap during a standardized task on the Kinarm robot. This fNIRS measure studies brain activity during a sensorimotor activity. |
| Motor Activity Log | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). | A semi-structured interview in which patients are asked how often (frequency) and how well (quality) they use the affected arm when performing upper extremity activities. Each category ranges from 0 to 5 points. A higher score indicates better frequency and quality. |
Countries
Belgium
Contacts
CONTACTCharlotte Heremans
Outcome results
None listed