Clinical trial NCT03008486: Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness
Official title: Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire UCLouvain Namur
First posted: 2017-01-02
Enrollment: 12
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Modified Ashworth Scale
timeFrame: Week 0, 1, 3, 4, 6, 12
measure: Change in the Modified Tardieu Scale
timeFrame: Week 0, 1, 3, 4, 6, 12
measure: Change in the Nociception Coma Scale-Revised
timeFrame: Week 0, 1, 3, 4, 6, 12
measure: Change in the Visual Analogue Scale
timeFrame: Week 0, 1, 3, 4, 6, 12
measure: Change in the Palm-finger distance
timeFrame: Week 0, 1, 3, 4, 6, 12
Secondary outcomes:
measure: Change in the Coma Recovery Scale-Revised
timeFrame: Week 0, 1, 3, 4, 6, 12
Other outcomes:
Locations:
city: Ottignies
country: Belgium
facility: Centre Hospitalier Neurologique William Lennox
state: Brabant Wallon
Study officials:
affiliation: Centre Hospitalier Neurologique William Lennox
name: Nicolas Lejeune
role: PRINCIPAL_INVESTIGATOR
References: