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

Phase 2

Completed

• Conditions: Craniocerebral Trauma; Disorder of Consciousness; Central Nervous System Diseases; Trauma, Nervous System; Stroke; Pathologic Processes; Neurocognitive Disorders; Brain Injuries; Hypertonic Disorder; Spasticity as Sequela of Stroke
• Interventions: Device: Real soft splint (6 cm); Device: Placebo soft splint (1 cm)

• Registration Number: NCT03008486
• Lead Sponsor: Géraldine Martens

Brief 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).

Study Timeline

• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2016-12-29
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Primary Completion: 2019-01
• Study Completion: 2019-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke - real	Real soft splint (6 cm)	Spastic patients stroke receiving the real soft splint
Stroke - placebo	Placebo soft splint (1 cm)	Spastic patients stroke receiving the placebo soft splint
DOC - placebo	Placebo soft splint (1 cm)	Spastic patients with disorders of consciousness receiving the placebo soft splint
DOC - real	Real soft splint (6 cm)	Spastic patients with disorders of consciousness receiving the real soft splint

Primary Outcome Measures

Name	Time	Method
Change in the Palm-finger distance	Week 0, 1, 3, 4, 6, 12	Range of motion assessment
Change in the Modified Tardieu Scale	Week 0, 1, 3, 4, 6, 12	Spasticity assessment
Change in the Visual Analogue Scale	Week 0, 1, 3, 4, 6, 12	Pain assessment
Change in the Nociception Coma Scale-Revised	Week 0, 1, 3, 4, 6, 12	Pain assessment
Change in the Modified Ashworth Scale	Week 0, 1, 3, 4, 6, 12	Spasticity assessment

Secondary Outcome Measures

Name	Time	Method
Change in the Coma Recovery Scale-Revised	Week 0, 1, 3, 4, 6, 12	Consciousness assessment

Trial Locations

Locations (1)

Centre Hospitalier Neurologique William Lennox; 🇧🇪 Ottignies, Brabant Wallon, Belgium