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| ID | Type | Description | Link |
|---|---|---|---|
| C2M/23/060 | Other Grant/Funding Number | KU Leuven |
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Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal intervention combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. However, the research team has developed a novel therapy paradigm combining robot-based training, a transfer package to daily life activities, and a home program. As a first step, the investigators will examine the feasibility and potential benefits of this novel therapy approach within this pilot study by recruiting 10 persons with chronic stroke. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke.
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal therapy combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. However, the research team has developed a novel therapy paradigm combining robot-based training, a transfer package to daily life activities, and a home program. As a first step, the investigators will examine the feasibility and potential benefits of this novel therapy approach within this pilot study. This intervention study will recruit 10 persons with chronic stroke. The participants will be measured a first time with both robot-based and clinical assessments. Thereafter, the participant follows a 4-week control period, only receiving standard care. After the control period, a second measuring moment is planned using the same outcome measures as during the first measurement. Then, a the 4-week intervention is planned, whereby participants get 48 hours additional sensorimotor upper limb training. The participants will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, the participants receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, the participants follow 6 times a week a 1-hour home program. After this intervention period, the particpants are measured a last time using the same outcome measures as during the previous measuring moments. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke.
Optionally, if the participants is willing and able to, additional MRI and/or fNIRS assessments will be added to give a first idea regarding changes in brain structure, function and activity because of this novel therapy approach. This study will inform the investigators to finalize the protocol for a following RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROBUST intervention | Experimental | The participants will be measured a first time with both robot-based and clinical assessments. Thereafter, the participant follows a 4-week control period, only receiving standard care. After the control period, a second measuring moment is planned using the same outcome measures as during the first measurement. Then, a the 4-week intervention is planned, whereby participants get 48 hours additional sensorimotor upper limb training. They will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, they follow 6 times a week a 1-hour home program. After this intervention period, they are measured a last time using the same outcome measures as during the previous measuring moments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROBUST | Behavioral | During a 4-week intervention, participants get 48 hours additional sensorimotor upper limb training. They will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, they follow 6 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 after 8 weeks. |
| 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 after 8 weeks. |
| Fugl-Meyer upper extremity assessment |
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Inclusion Criteria:
Exclusion Criteria:
Having musculoskeletal and/or other neurological disorders impacting care or prognosis
Having severe communication or cognitive deficits that interfere with the protocol
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 uncontrolled head movements (e.g. tremor), only relevant if participant is willing to receive the additional fNIRS assessments
Having any contra-indications for MRI, only relevant if participant is willing to receive the additional MRI assessments:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Leuven | 3001 | 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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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 after 8 weeks. |
| Tactile discrimination test | Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance | From first measuring moment to last measuring moment after 8 weeks. |
| Stroke Impact Scale | A self-report questionnaire that evaluates disability and health-related quality of life after stroke. A higher score indicates less disability and better quality of life. | From first measuring moment to last measuring moment after 8 weeks. |
| 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 after 8 weeks. |
| 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 after 8 weeks. |
| 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 after 8 weeks. |
| Optionally: MRI assessment | MRI scan to study the structure and function of the brain. | From first measuring moment to last measuring moment after 8 weeks. |
| Optionally: 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 after 8 weeks. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |