NCT05269745

Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

Neurologic changes caused by cerebral palsy (CP) result in adaptation of muscle architecture and function (e.g. shortened muscles and contractures). Stretching through immobilization (orthotic treatment) is one of the common interventions to bring the spastic muscle to growth. Positive outcomes of stretching through immobilization are increased range of motion and improved function. On the other hand, immobilization leads to disuse muscle atrophy. Hence, we hypothesize that combining a stretching through immobilization and muscle activity while controlling for foot deformity could be a superior treatment approach, which should lead to improved muscle morphology as well as function. The aim of the study is to examine the influence of two orthotic treatments (a standard regime and one new approach) on spastic plantar flexor muscles in children and adolescents with CP. The standard regime (stretching through immobilisation) includes a dynamic AFO (ankle-foot orthosis) used during day and night. The new approach combines stretching through immobilisation and allows for plantarflexor activity due to an innovative construction of the orthotic device. This prospective randomized controlled study will recruit 20 ambulant children and adolescents (aged 5 to 15 years) with cerebral palsy and equinus deformity (GMFCS = Gross Motor Function Classification System level I to III). Each child will be randomized and stratified according to age and GMFCS to one of two groups. The first group receives the standard treatment (stretching through immobilization) using custom-made ankle foot orthosis for 23 hours per day. The other group will be treated with the same orthosis at night (8 hours) and for 6 hours during the day but the remaining 10 hours will be treated with the foot shell only that corrects subtalar and Chopart joints but does not block the ankle joint movement, so that more activity of plantarflexors will be possible during the day. The intervention will last for 12 weeks. Each child will be examined at four occasions (8 weeks before intervention = control phase, at the beginning of the intervention and then 8 and 12 weeks later). The main outcome measure is the fascicle length measured using a 3D ultrasound (3DUS) imaging technique. Further parameters of interest span across the whole levels of ICF including clinical examinations, biomechanics of gait, muscle morphologic and mechanic properties and participations questionnaires.

Conditions

• Cerebral Palsy, Spastic

Interventions

Type	Name	Description
OTHER	Stretching through immobilisation (IG)	The immobilization group (IG) will receive the standard treatment, a dynamic ankle-foot orthosis (AFO) for night and day use (23 hours per day)
OTHER	Stretching through immobilisation and activity (IAG)	The Immobilization/Activity Group (IAG) will be treated with the same type of ankle-foot orthosis at night (8 hours) and for 6 hours during the day (altogether orthosis treatment 14 hours per day). The rest of the day (10 hours) children and adolescents will be using only the foot shell of orthoses (FS) without the lower leg shell, to secure the correct position of the foot and to allow a free motion at ankle joint with a good correction of the foot deformity (e.g. Pes equinovarus / equinovalgus, midfoot-break).
OTHER	Control Phase	Before the intervention with the orthotic treatment starts, a control phase of 8 weeks is planned. During this time, the individual orthoses for each subject are manufactured.

Timeline

• Start date: 2022-06-17
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2022-03-08
• Last updated: 2026-04-02

Locations

1 site across 1 country: Austria