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The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training with the device | Experimental | Training with new upper limb robot assisted therapy device |
|
| Control group | No Intervention | The control group is treated with conventional therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training with new upper limb robot assisted therapy device | Device | During 8 weeks, 3 times a week, 1 hour therapy sessions with the device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer test upper limb section | Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery. | Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks |
| Medical research council score | Muscle strength assessment | Change from baseline Medical research council score at 8 weeks and 12 weeks |
| Active range of motion of the elbow joint | The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently | Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks |
| Passive range of motion of the elbow joint | The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor. | Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks |
| Modified Ashworth Scale | Spasticity measurement | Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ABILHAND questionnaire | Questionnaire-based assessment of manual ability | Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks |
| Functional independence measure | Assessment of physical and cognitive disability, focusing on the burden of care. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lore Van de Perre, MSc | Contact | +32 14 56 23 10 | lore.van.de.perre@khk.be |
| Name | Affiliation | Role |
|---|---|---|
| Lore Van de Perre, MSc | Thomas More Kempen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas More Kempen | Geel | Antwepen | 2440 | 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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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| Change from baseline Functional independence measure score at 8 weeks and 12 weeks |
| Stroke impact scale | Questionnaire evaluating how stroke has impacted the person's health and life. | Change from baseline Stroke impact scale score at 8 weeks and 12 weeks |
| Intrinsic motivation inventory | Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments. | Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |