Clinical Trials Directory

Trials / Completed

CompletedNCT03008486

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Géraldine Martens · Academic / Other
Sex
All
Age
14 Years – 75 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEReal soft splint (6 cm)
DEVICEPlacebo soft splint (1 cm)

Timeline

Start date
2017-01-01
Primary completion
2019-01-01
Completion
2019-06-01
First posted
2017-01-02
Last updated
2019-09-25

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03008486. Inclusion in this directory is not an endorsement.