Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness

Conditions
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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

Intervention / Treatment
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* Device: Real soft splint (6 cm)
* Device: Placebo soft splint (1 cm)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DOC - real<br>Spastic patients with disorders of consciousness receiving the real soft splint | Device: Real soft splint (6 cm)<br> <br> |
| Placebo Comparator: DOC - placebo<br>Spastic patients with disorders of consciousness receiving the placebo soft splint | Device: Placebo soft splint (1 cm)<br> <br> |
| Active Comparator: Stroke - real<br>Spastic patients stroke receiving the real soft splint | Device: Real soft splint (6 cm)<br> <br> |
| Placebo Comparator: Stroke - placebo<br>Spastic patients stroke receiving the placebo soft splint | Device: Placebo soft splint (1 cm)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Coma Recovery Scale-Revised | Consciousness assessment | Week 0, 1, 3, 4, 6, 12 |