Centre Hospitalier Neurologique William Lennox
Ottignies, Brabant Wallon, 1340, Belgium
NCT Number: NCT03008486
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.
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Notify Me14 year–75 year
All sexes
Interventional
Phase 2
Ottignies, Brabant Wallon, 1340, Belgium
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(DOC):
Exclusion criteria
Inclusion criteria
(stroke):
Exclusion criteria
Time frame: Week 0, 1, 3, 4, 6, 12
Spasticity assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Spasticity assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Pain assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Pain assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Range of motion assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Consciousness assessment
Géraldine Martens
Other
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