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

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ClinicalTrials.gov Identifier: NCT03008486
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Information provided by (Responsible Party):
Géraldine Martens, University Hospital of Liege

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.

Condition or disease Intervention/treatment Phase
Brain Injuries Disorder of Consciousness Stroke Spasticity as Sequela of Stroke Contracture Hypertonic Disorder Central Nervous System Diseases Pathologic Processes Craniocerebral Trauma Trauma, Nervous System Neurocognitive Disorders Device: Real soft splint (6 cm) Device: Placebo soft splint (1 cm) Phase 2

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness
Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

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)



Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in the Coma Recovery Scale-Revised [ Time Frame: Week 0, 1, 3, 4, 6, 12 ]
    Consciousness assessment



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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008486


Contacts
Contact: Géraldine Martens, MSc +3243669676 geraldine.martens@ulg.ac.be
Contact: Caroline Symaÿs +3243662444

Locations
Belgium
Centre Hospitalier Neurologique William Lennox Recruiting
Ottignies, Brabant Wallon, Belgium, 1340
Contact: Nicolas Lejeune    +3210430211      
Sponsors and Collaborators
Géraldine Martens
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Investigators
Principal Investigator: Nicolas Lejeune Centre Hospitalier Neurologique William Lennox

Responsible Party: Géraldine Martens, PhD student, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT03008486     History of Changes
Other Study ID Numbers: 2016/292
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Craniocerebral Trauma
Disease
Stroke
Brain Injuries
Wounds and Injuries
Nervous System Diseases
Contracture
Central Nervous System Diseases
Neurocognitive Disorders
Consciousness Disorders
Pathologic Processes
Trauma, Nervous System
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms