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

Recruiting

Phase 2 Results N/A

Trial Description

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).

Conditions

Interventions

  • Real soft splint (6 cm) Device
    ARM 1: Kind: Experimental
    Label: DOC - real
    Description: Spastic patients with disorders of consciousness receiving the real soft splint
    ARM 2: Kind: Experimental
    Label: Stroke - real
    Description: Spastic patients stroke receiving the real soft splint
  • Placebo soft splint (1 cm) Device
    ARM 1: Kind: Experimental
    Label: DOC - placebo
    Description: Spastic patients with disorders of consciousness receiving the placebo soft splint
    ARM 2: Kind: Experimental
    Label: Stroke - placebo
    Description: Spastic patients stroke receiving the placebo soft splint

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in the Modified Ashworth Scale Week 0, 1, 3, 4, 6, 12
Primary Change in the Modified Tardieu Scale Week 0, 1, 3, 4, 6, 12
Primary Change in the Nociception Coma Scale-Revised Week 0, 1, 3, 4, 6, 12
Primary Change in the Visual Analogue Scale Week 0, 1, 3, 4, 6, 12
Primary Change in the Palm-finger distance Week 0, 1, 3, 4, 6, 12
Secondary Change in the Coma Recovery Scale-Revised Week 0, 1, 3, 4, 6, 12

Sponsors