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

Cerebral Palsy, Spastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05269745
• Other study ID #: 25940
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Ambulatory children with spastic CP.

• Ability to accept and follow verbal instruction.

• Limited range of motion in ankle joint - maximal dorsiflexion with knee extended = 5°

• Gross Motor Functional Classification System level I-III.

• Age 5-15 years.

• Willingness to participate.

Exclusion Criteria:

• Other than spastic form of CP (ataxic, athetoid or dystonic).

• Severe mental retardation.

• Normal range of motion in ankle joint

• Oral antispastic or muscle relaxing medication.

• History of orthopaedic surgery in the last 12 months.

• History of botulinum toxin type A application in the last six months.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Muscle Spasticity

Intervention

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)
• 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).
• 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.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mechano-morphological muscle-tendon properties - muscle volume	Gastrocnemius medialis muscle volume	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Primary	Change in mechano-morphological muscle-tendon properties - fascile length	Gastrocnemius medialis fascile length	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Primary	Change in mechano-morphological muscle-tendon properties - unit length	Gastrocnemius medialis muscle belly, tendon and muscle-tendon unit length	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Primary	Change in mechano-morphological muscle-tendon properties - elongation	Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit elongation due to externally applied torque to the ankle joint [elongation in mm]	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Primary	Change in mechano-morphological muscle-tendon properties - stiffness	Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit stiffness due to externally applied torque to the ankle joint [stiffness in N/mm]	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Primary	Change in joint range of motion	Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Primary	Change in maximal isometric muscle strength	Maximal isometric torque production (isokinetic dynamometry)	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Primary	Change in gait characteristics	Gait kinematics (joint angles [°]) and kinetics (joint moments [Nm/kg]) of the hip, knee, and ankle joints (3D motion capture). Joint angles [°] and moments [Nm/kg] will be combined to report changes in gait pattern.	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Secondary	Change in self-reported gait, mobility, and functional performance - GOAL	Gait Outcomes Assessment List (GOAL) Questionnaire	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Secondary	Change in self-reported gait, mobility, and functional performance - PODCI	Pediatrics Outcomes Data Collection Instrument (PODCI) Questionnaire	Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)