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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36506
Enrollment
24
Registered
2009-10-22
Start date
2010-03-16
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spastic children spastic diplegia and hemiplegia

Interventions

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 exte

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary outcome measure will be ankle range of motion to dorsiflexion.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)