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

Géraldine Martens

Status and phase: Completed; Phase 2

Conditions: Brain Injuries; Contracture; Hypertonic Disorder; Stroke; Spasticity as Sequela of Stroke; Trauma, Nervous System; Central Nervous System Diseases; Disorder of Consciousness; Neurocognitive Disorders; Craniocerebral Trauma; Pathologic Processes

Treatments: Device: Real soft splint (6 cm); Device: Placebo soft splint (1 cm)

Study type: Interventional

Funder types: Other

Identifiers

NCT03008486

2016/292

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 4 patient groups, including a placebo group

DOC - real

Active Comparator group

Description:

Spastic patients with disorders of consciousness receiving the real soft splint

Treatment:

Device: Real soft splint (6 cm)

DOC - placebo

Placebo Comparator group

Description:

Spastic patients with disorders of consciousness receiving the placebo soft splint

Treatment:

Device: Placebo soft splint (1 cm)

Stroke - real

Active Comparator group

Description:

Spastic patients stroke receiving the real soft splint

Treatment:

Device: Real soft splint (6 cm)

Stroke - placebo

Placebo Comparator group

Description:

Spastic patients stroke receiving the placebo soft splint

Treatment:

Device: Placebo soft splint (1 cm)