| Registry | NCT03008486 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 12 (Actual) |
| Sponsor | Géraldine Martens (Other); collaborators: Centre Hospitalier Universitaire UCLouvain Namur |
| Conditions | Brain Injuries, Disorder of Consciousness, Stroke, Spasticity as Sequela of Stroke, Contracture, Hypertonic Disorder, Central Nervous System Diseases, Pathologic Processes, Craniocerebral Trauma, Trauma, Nervous System, Neurocognitive Disorders |
| Interventions | Real soft splint (6 cm), Placebo soft splint (1 cm) (Device) |
| Dates | start 2017-01-01, primary completion 2019-01-01, completion 2019-06-01, first posted 2017-01-02, last updated 2019-09-25 |
| Locations | 1 site in Belgium |
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All trials for Brain Injuries All trials for Disorder of Consciousness All trials of Real soft splint (6 cm) All trials of Placebo soft splint (1 cm)
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DOC - real | Active comparator | Device: Real soft splint (6 cm) | Spastic patients with disorders of consciousness receiving the real soft splint |
| DOC - placebo | Placebo comparator | Device: Placebo soft splint (1 cm) | Spastic patients with disorders of consciousness receiving the placebo soft splint |
| Stroke - real | Active comparator | Device: Real soft splint (6 cm) | Spastic patients stroke receiving the real soft splint |
| Stroke - placebo | Placebo comparator | Device: Placebo soft splint (1 cm) | Spastic patients stroke receiving the placebo soft splint |
Sex: All, ages: 14 Years to 75 Years
Inclusion Criteria (DOC): * Altered state of consciousness according to international criteria since more than three months * Stable condition * Ashworth score > 1 for at least one upper limb joint Exclusion Criteria: * Bone fracture/lesion at the upper limbs * Serious neurological disorder (MMSE > 24) prior to the accident * Botox injection on the upper limbs in the 6 months preceding the inclusion Inclusion Criteria (stroke): * Central nervous system injury responsible for the spasticity * Ashworth score > 1 for at least one upper limb joint Exclusion Criteria: * Bone fracture/lesion at the upper limbs * Serious neurological disorder (MMSE > 24) * Botox injection on the upper limbs in the 6 months preceding the inclusion
| Facility | City | Country | Status |
|---|---|---|---|
| Centre Hospitalier Neurologique William Lennox | Ottignies, Brabant Wallon | Belgium |