NCT05269745

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

Completed NA Last updated 2 April 2026

What this trial tests

NA trial testing Stretching through immobilisation (IG) in Cerebral Palsy, Spastic in 14 participants. Completed in 30 September 2025.

Timeline

17 June 2022

Primary endpoint
30 September 2024

30 September 2025

Quick facts

Lead sponsor	Medical University of Graz
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	14
Start date	17 June 2022
Primary completion	30 September 2024
Estimated completion	30 September 2025
Sites	1 location across Austria

Drugs / interventions tested

• Stretching through immobilisation (IG)
• Stretching through immobilisation and activity (IAG)
• Control Phase

Conditions studied

• Cerebral Palsy, Spastic — all drugs for Cerebral Palsy, Spastic →

Sponsor

Medical University of Graz

Who can join

Adults 5 to 15, any sex, with Cerebral Palsy, Spastic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Influence of Immobilization, Stretching, and Activity on Isometric Muscle Strength and Gait in Young People with Spastic Cerebral Palsy.
   Svehlik M, Habersack A, Guggenberger B, Mosser N, et al · · 2026 · PMID 42194829 · DOI 10.3390/jcm15103869
2. Influence of Immobilization, Stretching, and Activity on the Morphological Properties of Spastic Gastrocnemius Muscles.
   Habersack A, Kruse A, Guggenberger B, Mosser N, et al · · 2026 · PMID 41897127 · DOI 10.3390/children13030414