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

NCT02888548 | Terminated

• 1 other identifier: PO14104*
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Spasticity

Outcome Measures

Primary Outcomes (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)

  up to 24 weeks

Study Arms (2)

Arm cross over 1

EXPERIMENTAL

botulinum toxins alone then botulinum toxins + orthos

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

Arm cross over 2

EXPERIMENTAL

botulinum toxins + orthosis then botulinum toxins alone

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

Interventions

botulinum toxins (Dysport°) alone PROCEDURE

botulinum toxins (Dysport°) alone

Arm cross over 1; Arm cross over 2

orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined PROCEDURE

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

Arm cross over 1; Arm cross over 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

Botulinum Toxins; abobotulinumtoxinA; Single Person; Orthotic Devices

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: April 22, 2016
• Primary Completion: May 18, 2016
• Study Completion: June 1, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

FR (1)