Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02888548 |
| Other study ID # |
PO14104* |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2016 |
| Est. completion date |
June 2021 |
Study information
| Verified date |
June 2021 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This prospective, multicentre, randomised, evaluation-blinded, crossover, pilot study, will
include different treatment cycles: a control cycle (toxin alone) and a study cycle (toxin +
splinting).
It will be conducted in two sites: CHU de Reims and UGECAM de Charleville Mézières.
The study population will include patients with upper limb spasticity associated with
functional impairment and/or pain. To be included, the patients must be non-naïve to
botulinum toxin, with a period of at least 4 months since the last toxin injections.
Each patient will be given botulinum toxin injections in the hypertonic muscles of his/her
upper limb at the beginning of each cycle, i.e. on D0 Phase 1 (D0P1) and D0 Phase 2 (D0P2).
This means each patient will receive two sets of injections at 5-month interval for the whole
duration of the study.
1. If the effect of the toxin is still present at 5 months (W20), the visit for the
following cycle may be delayed to ensure that both cycles are comparable (as per routine
practice).
2. If the effect is still present at the end of the second cycle, the patient follow-up
will be extended until the end of the effect.
As this is the first study of its type, the required number of subjects cannot be calculated
and the decision was taken to conduct a pilot study. The required number of patients has been
set at 30 for reasons of clinical relevance and study site capacity.
The patients will be randomised centrally into two arms of 15 patients each:
- Arm A: control cycle (toxin alone) followed by study cycle (toxin + splinting)
- Arm B: study cycle (toxin + splinting) followed by control cycle (toxin alone) The
second set of toxin injections will be performed 5 months after the first set. As the
effect of the toxin lasts 12 to 20 weeks maximum, this interval ensures that the effect
of the first injections will have worn off before the second set of injections is given.
Botulinum toxin will be administered under electrical stimulation guidance to improve the
accuracy of the injections in the muscles. Dysport® doses will be adjusted to the muscle
group being treated.
The post-injection rehabilitation protocol will be identical for both cycles, and include 10
sessions of physiotherapy to stretch the injected muscles (as per routine practice). The
prescription of these sessions will be standardised. These daily sessions will start the day
following the botulinum injections, and continue 5 times a week for 2 weeks for both
treatment phases.
For the study cycle, the splint will be worn only at night (8.00 pm to 8.00 am) for 4 weeks,
starting on the first evening after the toxin injection.
Any previous and on-going drug treatment will also be recorded. Concomitant oral antispastic
treatments will be authorised provided they were initiated prior to the patient's inclusion
in the study, and that dosage regimens remain unchanged.
The investigator performing the evaluations will be blinded to the treatment cycle, i.e.
he/she will not know which treatment cycle the patient is currently in. Therefore, the
evaluating, injecting and splint-referring physicians will be three different people. To
limit potential biases, these 3 persons will remain the same during all the study for all the
patients included.
