A Phase 2 interventional study of Real soft splint (6 cm) and Placebo soft splint (1 cm) in Brain Injuries, Disorder of Consciousness and Stroke, sponsored by Géraldine Martens. Completed at 1 site in Belgium. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Géraldine Martens · Phase 2, Interventional, and Treatment
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).
151 studies on the registry are indexed under Contracture; 21 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 110 interventional studies indexed under Contracture.
Browse Contracture studies →This is the only study on the registry with Géraldine Martens as lead sponsor.
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Inclusion Criteria (DOC):
Exclusion Criteria:
Inclusion Criteria (stroke):
Exclusion Criteria:
Spastic patients with disorders of consciousness receiving the real soft splint
Device: Real soft splint (6 cm)
Spastic patients with disorders of consciousness receiving the placebo soft splint
Device: Placebo soft splint (1 cm)
Spastic patients stroke receiving the real soft splint
Device: Real soft splint (6 cm)
Spastic patients stroke receiving the placebo soft splint
Device: Placebo soft splint (1 cm)
Change in the Modified Ashworth Scale
Spasticity assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Modified Tardieu Scale
Spasticity assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Nociception Coma Scale-Revised
Pain assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Visual Analogue Scale
Pain assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Palm-finger distance
Range of motion assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Coma Recovery Scale-Revised
Consciousness assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Plan to share: No
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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