Skip to main content
OpenTrials
Completed

NCT Number: NCT03008486

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real soft splint (6 cm)

Device

Placebo soft splint (1 cm)

Device

Primary outcomes

  1. Change in the Modified Ashworth Scale

    Time frame: Week 0, 1, 3, 4, 6, 12

    Spasticity assessment

  2. Change in the Modified Tardieu Scale

    Time frame: Week 0, 1, 3, 4, 6, 12

    Spasticity assessment

  3. Change in the Nociception Coma Scale-Revised

    Time frame: Week 0, 1, 3, 4, 6, 12

    Pain assessment

  4. Change in the Visual Analogue Scale

    Time frame: Week 0, 1, 3, 4, 6, 12

    Pain assessment

  5. Change in the Palm-finger distance

    Time frame: Week 0, 1, 3, 4, 6, 12

    Range of motion assessment

Secondary outcomes

  1. Change in the Coma Recovery Scale-Revised

    Time frame: Week 0, 1, 3, 4, 6, 12

    Consciousness assessment

Sponsors and collaborators

Lead sponsor

Géraldine Martens

Other

Collaborators

  • Centre Hospitalier Universitaire UCLouvain Namur

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2017
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.