The efficacy of night splinting in children with cerebral palsy, a randomised controlled trial

Completed

Conditions: spastic children
spastic diplegia and hemiplegia
10028037

Registration Number: NL-OMON36506

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be ankle range of motion to dorsiflexion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures will be i) maximal knee extension in stance<br /><br>during gait, ii) ankle dorsiflexion in mid stance during gait and iii) the<br /><br>gross motor function measure.<br /><br>The outcome measures will be morphological parameters like achilles tendon<br /><br>length, muscle belly length, muscle fibre length, muscle physiological cross<br /><br>sectional area length and fibre pennation angle. </p><br>