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Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing Dynamic Hand Splinting in Adults With Post-stroke Hemiplegia (Orthox) (ORTHOX)

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ClinicalTrials.gov Identifier: NCT02888548
Recruitment Status : Not yet recruiting
First Posted : September 5, 2016
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies suggested combining botulinum toxin injections with splinting to optimise rehabilitation in spastic patients. However, one study focused exclusively on lower limb spasticity, the second on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.

A study was performed in adult patients with upper limb spasticity treated with botulinum toxin injections used as primary objective the tolerance for dynamic splinting. The authors noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been conducted to date on the splinting + toxin combination in adults.

Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days after botulinum treatment.

Based on this principle, we hypothesise that dynamic night splinting applied just after botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint providing continuous stretching of the wrist and fingers in extension whilst allowing active flexion. Night splinting is thought to promote optimal functional use of the paretic upper limb during the day and thus prevent learned non-use, which could worsen the spasticity.

Each patient will receive treatment cycles, whose results will be compared, so that each patient will act as his/her own control. The evaluation will be based on the Tardieu scale chosen for its greater inter-individual reproducibility and greater reliability to measure spasticity.

The degree of extension of wrist and fingers provided by the splint will be adjusted to the patient's clinical condition with the elastic tensioners. The purpose of the splint is to maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching maximum extension, which could be harmful.

This protocol is designed to determine whether dynamic night hand splinting combined with botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain damage.


Condition or disease Intervention/treatment Phase
Upper Limb Spasticity Procedure: botulinum toxins (Dysport°) alone Procedure: orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing the Antispastic Efficacy and Safety of Dynamic Night Hand Splinting in Adults With Post-stroke Hemiplegia Treated by Botulimum Toxin (Dysport®) - (a Pilot Study)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Arm cross over 1
botulinum toxins alone then botulinum toxins + orthos
Procedure: botulinum toxins (Dysport°) alone
botulinum toxins (Dysport°) alone

Procedure: orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined
orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined

Experimental: Arm cross over 2
botulinum toxins + orthosis then botulinum toxins alone
Procedure: botulinum toxins (Dysport°) alone
botulinum toxins (Dysport°) alone

Procedure: orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined
orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined




Primary Outcome Measures :
  1. Comparison of the angle variation in degrees measured at fast speed V3 on the Tardieu Scale from W4 to D0 between the control cycle (toxin alone) and the splinting cycle (toxin + splint), in a given patient (ie W4-D0 versus W24-W20) [ Time Frame: up to 24 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age between 18 and 80 years old
  • Male or female
  • Ischemic or haemorrhagic stroke more than 6 months ago
  • Upper limb spasticity defined by:
  • Modified Ashworth Scale (MAS) score > 1
  • Disability Assessment Scale (DAS) score > 2
  • Spasticity angle (Tardieu) > 10°
  • Patient's written informed consent
  • History of botulinum toxin treatment

Non inclusion criteria:

  • Major limitation of passive range of motion in the elbow, wrist and fingers, preventing splinting:
  • Maximum passive extension of the elbow < 150°
  • Maximum passive extension of the wrist < 70°
  • Maximum passive extension of the fingers < 70°
  • Local skin complication preventing splinting (allergy)
  • Behavioural disorder preventing splinting
  • Adults falling under the Adult Protection Act or unable to give their consent (article L-1121-8 of the French Public Health Code), persons deprived of their liberty or hospitalised without their consent (article L-1121-6 of the French Public Health Code), and pregnant or breastfeeding women (article L-1121-5 of the French Public Health Code).
  • Botulinum toxin injections administered less than 4 months from inclusion.
  • Contraindications to botulinum toxin (breastfeeding, myasthenia, aminosid, hypersensibility to botulinum toxin or related compounds).
  • Concomitant participation in another biomedical study.

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): NCT02888548


Contacts
Contact: Francois BOYER 326788961 fboyer@chu-reims.fr

Locations
France
Chu de Reims Recruiting
Reims, France, 51092
Contact: Francois BOYER       fboyer@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02888548     History of Changes
Other Study ID Numbers: PO14104
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents