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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brabant Wallon
    • Ottignies, Brabant Wallon, Belgium, 1340
      • Centre Hospitalier Neurologique William Lennox

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: DOC - real; Spastic patients with disorders of consciousness receiving the real soft splint	Device: Real soft splint (6 cm)
PLACEBO_COMPARATOR: DOC - placebo; Spastic patients with disorders of consciousness receiving the placebo soft splint	Device: Placebo soft splint (1 cm)
ACTIVE_COMPARATOR: Stroke - real; Spastic patients stroke receiving the real soft splint	Device: Real soft splint (6 cm)
PLACEBO_COMPARATOR: Stroke - placebo; Spastic patients stroke receiving the placebo soft splint	Device: Placebo soft splint (1 cm)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Coma Recovery Scale-Revised	Consciousness assessment	Week 0, 1, 3, 4, 6, 12

Collaborators and Investigators

• Sponsor: Géraldine Martens
• Collaborators: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
• Investigators: Principal Investigator: Nicolas Lejeune, Centre Hospitalier Neurologique William Lennox

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: December 26, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (ESTIMATE): January 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stroke; Disease; Brain Injuries; Wounds and Injuries; Nervous System Diseases; Consciousness Disorders; Craniocerebral Trauma; Trauma, Nervous System; Pathologic Processes; Contracture; Central Nervous System Diseases; Neurocognitive Disorders
• Other Study ID Numbers: 2016/292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO