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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke experimental group | Experimental | The stroke experimental group will receive a 48-hour ROBUST intervention (in addition to their standard care) spread over 5 weeks, followed by a 4-week follow-up period (only standard care). |
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| Stroke control group | Other | The stroke control group will first receive their standard care only over 5 weeks (no additional intervention), followed by a 4-week follow-up period (only standard care). Thereafter, this group will receive a 12-hour Kinarm-therapy (one part of the ROBUST intervention, additional to their standard care) spread over 5 weeks, followed by another 4-week follow-up period (only standard care). |
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| Healthy control group | Other | The healthy control group will first have a 4-week control period whereby they do not receive additional training, followed by a 12-hour Kinarm therapy (one part of the ROBUST intervention) spread over 5 weeks. Thereafter, they have a 4-week follow-up period (no extra training). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROBUST | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test | Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensorimotor Action Research Arm Test | Clinical assessment of sensorimotor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Fugl-Meyer Assessment for the upper extremity |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Cognitive Screen | A domain-specific cognitive screening tool. The domains assessed are Language, Praxis, Number, Memory, Spatial and Controlled Attention. The following tasks are included: Picture Naming (range: 0-4), Semantics (range: 0-3), Orientation (range: 0-4), Visual Field (range: 0-4), Sentence Reading (range: 0-15), Number Writing (range: 0-3), Calculation (range: 0-4), Broken Hearts Test (range: 0-50), Imitation (range: 0-12), Verbal Recall & Recognition (range: 0-4), Episodic recognition (range: 0-4) and Executive task (perfect outcome = -1). Higher scores mean better cognitive performance, except for the Executive task. |
Inclusion Criteria stroke participants:
Inclusion Criteria healthy participants:
Exclusion Criteria:
Having musculoskeletal and/or other neurological disorders impacting care or prognosis;
Having severe communication or cognitive deficits that interfere with the protocol;
Having severe spasticity (cannot handle Kinarm robot);
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP;
Contraindications for robot-based therapy (e.g., uncontrolled epilepsy);
Participation in another clinical investigation;
Having any contraindications for fNIRS*:
Having any contraindications for MRI**:
Currently undergoing a structured arm and/or hand training (e.g. engaging in playing a musical instrument)**.
Stroke patients and healthy participants showing these exclusion criteria will be included in the RCT protocol, but will not be measured with fNIRS.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Heremans | Contact | +32 0483 746 007 | robust@kuleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven, Gebouw De Nayer | Leuven | Belgium |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Kinarm therapy | Behavioral | 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. |
|
Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance. |
| From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Tactile Discrimination Test | Clinical assessment of sensory processing with an area under the curve based scoring system ranging from 0-100%, with higher scores meaning better performance. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Stroke Impact Scale | 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. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Motor Activity Log | 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. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Kinarm: Visually Guided Reaching Task | Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Kinarm: Arm Position Matching Task | Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Kinarm: Passive and Active Discrimination Task | Task on the Kinarm End-Point Lab used to assess passive and active sensory processing. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| MRI assessment | MRI scan to study the structure and function of the brain, during rest and during a sensorimotor upper limb task. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| fNIRS assessment | 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. | From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation). |
| Only during the first measuring moment. |
| Motivation for Rehabilitation Scale | A questionnaire investigating the motivation of the patient for following rehabilitation ranging from 0 to 119 points. A higher score means a higher motivation. | Between the first measuring moment until the second/fourth measuring moment (5-14 weeks, depending on group allocation). |
| Patient Experience Questionnaire | A study-specific questionnaire to gather feedback regarding the ROBUST intervention. Included questions where multiple-choice questions, questions ranging from fully agree to fully disagree, and open questions. | Only during the last therapy session of the ROBUST intervention in the stroke experimental group (5 weeks). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |