1) To evaluate the efficacy of knee-ankle-foot orthoses (worn by night) in preventing a decrease of range of motion to ankle dorsiflexion in children with cerebral palsy (Clinical part). 2) To evaluate the effect of night-worn knee-ankle-foot…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be ankle range of motion to dorsiflexion.
Secondary outcome
The secondary outcome measures will be i) maximal knee extension in stance
during gait, ii) ankle dorsiflexion in mid stance during gait and iii) the
gross motor function measure.
The outcome measures will be morphological parameters like achilles tendon
length, muscle belly length, muscle fibre length, muscle physiological cross
sectional area length and fibre pennation angle.
Background summary
Children with cerebral palsy often have an impaired range of motion of the
ankle. The decreased range of motion develops over time. Although the
underlying mechanism behind the decreasing range of motion is not clear, it is
supposed that impaired range of motion is caused by an insufficient length of
the m. gastrocnemius. Treatments for impaired ankle range of motion seems to be
effective on the short term, but not on the long term. Therefore, prevention
for a decrease of range of motion is necesarry.
Study objective
1) To evaluate the efficacy of knee-ankle-foot orthoses (worn by night) in
preventing a decrease of range of motion to ankle dorsiflexion in children with
cerebral palsy (Clinical part). 2) To evaluate the effect of night-worn
knee-ankle-foot orthosis on muscle morphology in children with cerebral palsy
(Morphological part).
Study design
A single blind randomised controlled trial will be performed. Two groups will
be investigated. One group will be treated for muscle shortening (prevention of
recurrence of decrease of range of motion) a dynamic knee-ankle-foot orthosis
for 1 year and one group will be included as a control group receiving usual
care. Children needing treatment for reduced ankle dorsiflexion will be treated
with botuline toxine A injections, serial casting and/or KAFOs during the first
three months of the study. Randomisation will be performed after three months.
Measurements will be performed at baseline and after 3, 6, 9 and 12 months.
Intervention
One group will be treated with a custom made dynamic knee-ankle-foot orthosis
using an ultraflex ankle power unit (variable ankle angle). The knee-ankle-foot
orthoses has a fixed 0 degrees knee extension. The control group will receive
usual care only. All groups continue with their usual therapies.
Study burden and risks
It is hypothesised that the treatment will prevent a decrease of range of
motion of the ankle in children with cerebral palsy. Besides, the results of
this study can improve the treatment of these children as this study will give
more insight in the underlying mechanisms of the children's decreasing ankle
range of motion and the effects of the treatment. The risks of this study are
comparable to normal treatment of children with cerebral palsy. We believe the
benefits clearly outweigh the risks or burdens for the subjects.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
They have a clinical diagnosis of unilateral or bilateral spastic CP
They have an age between 4-12 years old
They have a range of motion in the ankle of 0º plantar flexion or less with an extended knee, tested by a clinician with a manual force.
They are able to walk with or without aids (GMFCS class 1-3).
They have a range of motion in the ankle less than 5º with an extended knee, tested by the clinician with reasonable manual force and will be treated with:
* Botulinum toxin A injections in the m. Gastrocnemius
* AND/OR serial casting
* AND/OR orthotic management in rest with a Knee-Ankle-Foot-Orthosis
o OR they have a range of motion in the ankle less than 20 degrees and more than 0 degrees dorsiflexion and they have been treated for a decreased range of motion (defined as less than 5 degrees dorsiflexion) in the ankle in the past by:
* Botulinum toxin A injections in the m. Gastrocnemius (at least 6 months ago)
* AND/OR serial casting (at least 3 months ago)
* AND/OR orthotic management in rest with a Knee-Ankle-Foot-Orthosis
They live in a stable social family situation.
Exclusion criteria
Surgery of the Gastrocnemius and/or Soleus muscle has been performed in the past.
A Selective Dorsal Rhizotomy has been performed in the past
There is administration of treatment of Intra Thecal Baclofen therapy
The cannot extend their knees fully.
They have behavioural problems or sleeping problems.
The child is institutionalized.
There is co-morbidity interfering with mobility.
Parents/guardians and/or child do not understand the Dutch or English language well enough to take part in this project
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL28986.029.09 |
| OMON | NL-OMON27440 |