Cerebral Palsy, SpasticNCT05269745
Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle
A study testing Stretching through immobilisation (IG) and Stretching through immobilisation and activity (IAG) in people with Cerebral Palsy, Spastic, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Stretching through immobilisation (IG) and Stretching through immobilisation and activity (IAG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 17 Jun 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Stretching through immobilisation (IG), Stretching through immobilisation and activity (IAG), Control Phase
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching through immobilisation (IG)Other
Also called 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)Other
Also called 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 PhaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immobilization group (IG) | Active comparator | One group - immobilization group (IG) - will receive the standard treatment. Receives: Other: Stretching through immobilisation (IG) |
| Immobilization/Activity Group (IAG) | Experimental | The other group - Immobilization/Activity Group (IAG) - will be treated with a new approach. Receives: Other: Stretching through immobilisation and activity (IAG) |
| Control Phase | Other | Before the intervention with the orthotic treatment starts, a control phase of 8 weeks is planned. Receives: Other: Control Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mechano-morphological muscle-tendon properties - muscle volume
Gastrocnemius medialis muscle volume
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Change in mechano-morphological muscle-tendon properties - fascile length
Gastrocnemius medialis fascile length
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Change in mechano-morphological muscle-tendon properties - unit length
Gastrocnemius medialis muscle belly, tendon and muscle-tendon unit length
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
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]
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
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]
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Change in joint range of motion
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Change in maximal isometric muscle strength
Maximal isometric torque production (isokinetic dynamometry)
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
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.
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Secondary outcomes (2)
Change in self-reported gait, mobility, and functional performance - GOAL
Gait Outcomes Assessment List (GOAL) Questionnaire
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Change in self-reported gait, mobility, and functional performance - PODCI
Pediatrics Outcomes Data Collection Instrument (PODCI) Questionnaire
Measured: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start17 Jun 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Graz
- Responsible party
- Sponsor
- Investigators
- Andreas Habersack, BSc MSc, Principal investigator, Medical University of GrazMartin Svehlik, MD PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269745
- Sponsor's protocol ID
- 25940
- Status last verified
- Oct 2025
- First submitted
- 14 Feb 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is yet not decided if individual data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle
- ClinicalTrials.gov ID
- NCT05269745
- Acronym / sponsor ID
- 25940
- Conditions
- Cerebral Palsy, Spastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- University of Graz
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immobilization group (IG) | Active comparator | Other: Stretching through immobilisation (IG)One group - immobilization group (IG) - will receive the standard treatment. |
| Immobilization/Activity Group (IAG) | Experimental | Other: Stretching through immobilisation and activity (IAG)The other group - Immobilization/Activity Group (IAG) - will be treated with a new approach. |
| Control Phase | Other | Other: Control PhaseBefore the intervention with the orthotic treatment starts, a control phase of 8 weeks is planned. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretching through immobilisation (IG)Also: IGThe immobilization group (IG) will receive the standard treatment, a dynamic ankle-foot orthosis (AFO) for night and day use (23 hours per day) | Other | Immobilization group (IG) |
| Stretching through immobilisation and activity (IAG)Also: IAGThe 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 | Immobilization/Activity Group (IAG) |
| Control PhaseBefore 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. | Other | Control Phase |
Primary outcome
Change in mechano-morphological muscle-tendon properties - muscle volume
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Gastrocnemius medialis muscle volume
Change in mechano-morphological muscle-tendon properties - fascile length
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Gastrocnemius medialis fascile length
Change in mechano-morphological muscle-tendon properties - unit length
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Gastrocnemius medialis muscle belly, tendon and muscle-tendon unit length
Change in mechano-morphological muscle-tendon properties - elongation
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit elongation due to externally applied torque to the ankle joint [elongation in mm]
Change in mechano-morphological muscle-tendon properties - stiffness
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit stiffness due to externally applied torque to the ankle joint [stiffness in N/mm]
Change in joint range of motion
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Change in maximal isometric muscle strength
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Maximal isometric torque production (isokinetic dynamometry)
Change in gait characteristics
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
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.
2 secondary outcomes
Change in self-reported gait, mobility, and functional performance - GOAL
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Change in self-reported gait, mobility, and functional performance - PODCI
Time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. It is yet not decided if individual data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Habersack, BSc MSc principal investigator
Medical University of Graz
Martin Svehlik, MD PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching through immobilisation (IG) and Stretching through immobilisation and activity (IAG) in people with Cerebral Palsy, Spastic, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mechano-morphological muscle-tendon properties - muscle volume (time frame: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.