Brain Injuries, Central Nervous System Diseases, Contracture, Craniocerebral Trauma, Disorder of Consciousness, Hypertonic Disorder, Neurocognitive Disorders, Pathologic Processes, Spasticity as Sequela of Stroke, Stroke, Trauma, Nervous System
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEReal soft splint (6 cm)
DEVICEPlacebo soft splint (1 cm)
Sponsors
Centre Hospitalier Universitaire UCLouvain Namur
Géraldine Martens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Modified Ashworth Scale | Week 0, 1, 3, 4, 6, 12 | Spasticity assessment |
| Change in the Modified Tardieu Scale | Week 0, 1, 3, 4, 6, 12 | Spasticity assessment |
| Change in the Nociception Coma Scale-Revised | Week 0, 1, 3, 4, 6, 12 | Pain assessment |
| Change in the Visual Analogue Scale | Week 0, 1, 3, 4, 6, 12 | Pain assessment |
| Change in the Palm-finger distance | Week 0, 1, 3, 4, 6, 12 | Range of motion assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Coma Recovery Scale-Revised | Week 0, 1, 3, 4, 6, 12 | Consciousness assessment |
Countries
Belgium
Outcome results
None listed