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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire UCLouvain Namur | OTHER |
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The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.
Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major muscular troubles such as spasticity. This spasticity may induce pain, loss in range of motion and permanent joint deformities. The aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50 with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter).
Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOC - real | Active Comparator | Spastic patients with disorders of consciousness receiving the real soft splint |
|
| DOC - placebo | Placebo Comparator | Spastic patients with disorders of consciousness receiving the placebo soft splint |
|
| Stroke - real | Active Comparator | Spastic patients stroke receiving the real soft splint |
|
| Stroke - placebo | Placebo Comparator | Spastic patients stroke receiving the placebo soft splint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real soft splint (6 cm) | Device |
| ||
| Placebo soft splint (1 cm) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Modified Ashworth Scale | Spasticity assessment | Week 0, 1, 3, 4, 6, 12 |
| Change in the Modified Tardieu Scale | Spasticity assessment | Week 0, 1, 3, 4, 6, 12 |
| Change in the Nociception Coma Scale-Revised | Pain assessment | Week 0, 1, 3, 4, 6, 12 |
| Change in the Visual Analogue Scale | Pain assessment | Week 0, 1, 3, 4, 6, 12 |
| Change in the Palm-finger distance | Range of motion assessment | Week 0, 1, 3, 4, 6, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Coma Recovery Scale-Revised | Consciousness assessment | Week 0, 1, 3, 4, 6, 12 |
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Inclusion Criteria (DOC):
Exclusion Criteria:
Inclusion Criteria (stroke):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Lejeune | Centre Hospitalier Neurologique William Lennox | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Neurologique William Lennox | Ottignies | Brabant Wallon | 1340 | Belgium |
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| Device |
|
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D003244 | Consciousness Disorders |
| D020521 | Stroke |
| D003286 | Contracture |
| D002493 | Central Nervous System Diseases |
| D010335 | Pathologic Processes |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
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