Cerebral Palsy Clinical Trial
Official title:
Improving Stretching Interventions for Children With Cerebral Palsy
Cerebral palsy (CP) has a prevalence of 1.5-3 per 1000 live births, making it the most common neurological disorder among children in Europe. One of the most frequently observed problems in CP is hypertonia, i.e. increased muscle tension, which can result in contractures. Stretching therapies are widely used as a treatment for contractures, but with highly variable success. Therefore, efforts are needed to improve the efficacy of stretching interventions. The investigators hypothesise that increasing the stiffness of the tendon relative to the muscle, by resistance training, prior to stretching will improve the efficacy of stretching interventions in children with CP. In a RCT design the investigators will compare a group of children receiving a combined strengthening-stretching intervention of the calf muscle to a control group receiving conventional stretching exercises in combination with upper limb exercises. Outcome measures will include muscle-tendon structure and gait analysis to assess functional improvements. This research will improve the understanding of muscle responses to stretching interventions in children with CP and can lead to more effective stretching therapies.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 7 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Diagnosed with spastic cerebral palsy - GMFCS level I-III - Have the ability to perform at least one bi-lateral heel raise. - Aged 7 to 14 Exclusion Criteria: - Orthopaedic or neural surgery to the lower limb 2 years prior to or planned during the intervention - Botulinum Toxin A injections 6 months prior to or planned during the intervention. - A learning or behaviour impairment that prevents full participation in the intervention. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Liverpool John Moores University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change Muscle fascicle length of the Gastrocnemius (mm) | B-mode ultrasound images will be captured at the mid muscle belly. From these, fascicle length will be defined as the straight line distance between the upper and the lower aponeurosis parallel to the lines of collagenous tissue. | at baseline and after 10 weeks | No |
Primary | Change in Gastrocnemius muscle length (mm) | B-mode ultrasound images will be captured of the myotendinous junction and the medial femoral condyl. Muscle length will be defined as the straight line distance between these two anatomical points. | at baseline and after 10 weeks | No |
Secondary | Change in ankle range of motion (degree) | The difference in ankle angle measured at maximal plantar flexion and maximal dorsi flexion with a goniometer | at baseline and after 10 weeks | No |
Secondary | Change in Achilles tendon stiffness (Nm) | Tendon stiffness is quantified as the change in tendon length per change in tendon force. Tendon lengthening will be quantified, using B-mode ultrasound, from the displacement of the myotendinous junction during the MVC trials. Tendon force will be calculated from the ratio of nett joint moment to Achilles tendon moment arm. |
at baseline, after 4 weeks and after 10 weeks | No |
Secondary | Change in maximal dorsiflexion angle during gait (degree) | Maximal dorsiflexion angles will be quantified from kinematic data obtained during the gait analysis | at baseline and after 10 weeks | No |
Secondary | Change in lengthening properties of the muscle fascicles (mm) | The ankle will be moved passively through the full range of motion. B-mode ultrasound images of the mid belly of the medial gastrocnemius will be collected throughout on which muscle fascicle lengthening will be measured | at baseline and after 10 weeks | No |
Secondary | Changes in step length during gait (m) | Step length will be quantified from the kinematic data obtained during the gait analysis | at baseline and after 10 weeks | No |
Secondary | Changes in ankle power at push of during gait | Ankle power will be quantified from kinematic and kinetic data obtained during the gait analysis | at baseline and after 10 weeks | No |
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