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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008486
• Other study ID #: 2016/292
• Status: Completed
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: September 2019
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Central Nervous System Diseases
• Consciousness Disorders
• Contracture
• Craniocerebral Trauma
• Disease
• Disorder of Consciousness
• Hypertonic Disorder
• Nervous System Diseases
• Neurocognitive Disorders
• Pathologic Processes
• Spasticity as Sequela of Stroke
• Stroke
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Device:
• Real soft splint (6 cm)

• Placebo soft splint (1 cm)

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Neurologique William Lennox	Ottignies	Brabant Wallon

Sponsors (2)

Lead Sponsor	Collaborator
Géraldine Martens	Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Modified Ashworth Scale	Spasticity assessment	Week 0, 1, 3, 4, 6, 12
Primary	Change in the Modified Tardieu Scale	Spasticity assessment	Week 0, 1, 3, 4, 6, 12
Primary	Change in the Nociception Coma Scale-Revised	Pain assessment	Week 0, 1, 3, 4, 6, 12
Primary	Change in the Visual Analogue Scale	Pain assessment	Week 0, 1, 3, 4, 6, 12
Primary	Change in the Palm-finger distance	Range of motion assessment	Week 0, 1, 3, 4, 6, 12
Secondary	Change in the Coma Recovery Scale-Revised	Consciousness assessment	Week 0, 1, 3, 4, 6, 12