Cerebral PalsyNCT02766491
Improving Stretching Interventions for Children With Cerebral Palsy
A study testing Strengthening and stretching and conventional stretching in people with Cerebral Palsy, run by Liverpool John Moores University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Strengthening and stretching and conventional stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2016
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Cerebral palsy (CP) is a disorder resulting from a non-progressive lesion in the brain during pregnancy or early childhood. Children with CP show impaired movement patterns compared to typically developing (TD) children. One of the main factors limiting movement in children with CP is a reduced range of motion (ROM), which can be caused by a combination of neural and mechanical factors. Mechanical factors contributing to a reduced ROM are increased muscle/fascicle stiffness, reduced muscle length and changes in intramuscular tissue properties, all of which contribute to contractures.
Contractures are conservatively treated with stretching therapies, e.g., casting, night splints and physical therapy. However, they are very demanding for both children and parents, especially physical therapy which is painful and time-consuming. Therefore, when recommending stretching therapies, we need to assure they are efficacious. However, recent reviews show that the outcomes of stretching therapies in children with CP are highly variable.
Stretching interventions aim to improve ROM motion by increasing the overall length and/or lengthening properties of the muscle. To successfully achieve these adaptations, the muscle must experience adequate tensile stimulus during the intervention. However, it has been shown by previous studies examining muscle behaviour during stretch, that the muscle and fascicles in children with CP lengthen less than in TD children. Our own studies have confirmed this observations at the muscle, but also shown that the tendon in children with CP lengthens more during a stretch, than in TD children. These observations indicate that the higher stiffness of the target muscle relative to the in series tendon prevents the muscle fibres to experience a sufficiently large stretching stimulus, and the adaptations are small. Accordingly, in a recent study on long term stretching interventions it has been shown that muscle and fascicle strain increase, but no changes in the muscle's resting length or functional improvements have been found.
If you were to increase the stiffness of the tendon relative to the muscle prior to the stretching intervention, a greater stretching stimulus could be provided to the muscle. This would mean that for any given joint stretch the muscle will experience a greater portion of the stretch. It is well established in healthy adults and children that the stiffness of the tendon increases following resistance training. Given that well-designed resistance training is effective and safe for children with CP, the same increased tendon stiffness should follow gains in muscle strength in this group too. It is therefore hypothesise that a combined strengthening-stretching intervention would stiffen the tendon, increase the amount of stretch seen by the muscle, and thereby improve the effectiveness of stretching interventions.
- Conditions
- Cerebral Palsy
- Being tested
- Strengthening and stretching, conventional stretching
- Keywords
- Stretching
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening and stretchingOther
Strengthening exercises will be performed 4 times a week for 10 weeks. Single leg heel raises will be the preferred exercise performed. The group of participants will have a wide range of strength and functional abilities, this will be accounted for with individualised programmes. The exercise load can be reduced by switching to bilateral heel raises, giving external support, reducing the range of motion or performing the heel raises while seated. Exercise load will be progressively increased by adding weight in the form of water bottles to a rucksack worn on the participant's back.
For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed.
conventional stretchingOther
This group will perform seated biceps curls 4 times a week for 10 weeks, where extra load can be added progressively by holding water bottles in the hand.
For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening and stretching | Experimental | The intervention group will follow a strengthening-stretching program of the calf muscles. Receives: Other: Strengthening and stretching |
| conventional stretching | Active comparator | The control group will receive conventional stretching and strengthening exercises to the upper limb to assure that the same systemic physiological stimuli and a similar number of contact hours is received. Receives: Other: conventional stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and after 10 weeks
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.
Measured: at baseline and after 10 weeks
Secondary outcomes (6)
Change in ankle range of motion (degree)
The difference in ankle angle measured at maximal plantar flexion and maximal dorsi flexion with a goniometer
Measured: at baseline and after 10 weeks
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.
Measured: at baseline, after 4 weeks and after 10 weeks
Change in maximal dorsiflexion angle during gait (degree)
Maximal dorsiflexion angles will be quantified from kinematic data obtained during the gait analysis
Measured: at baseline and after 10 weeks
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
Measured: at baseline and after 10 weeks
Changes in step length during gait (m)
Step length will be quantified from the kinematic data obtained during the gait analysis
Measured: at baseline and after 10 weeks
Changes in ankle power at push of during gait
Ankle power will be quantified from kinematic and kinetic data obtained during the gait analysis
Measured: at baseline and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Kalkman, Liverpool John Moores University
- Investigators
- Thomas D O'Brien, PhD, Study director, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766491
- Sponsor's protocol ID
- Stretching_CP_V1
- Status last verified
- May 2016
- First submitted
- 19 Apr 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kalkman BM, Holmes G, Bar-On L, Maganaris CN, Barton GJ, Bass A, Wright DM, Walton R, O'Brien TD. Resistance Training Combined With Stretching Increases Tendon Stiffness and Is More Effective Than Stretching Alone in Children With Cerebral Palsy: A Randomized Controlled Trial. Front Pediatr. 2019 Aug 13;7:333. doi: 10.3389/fped.2019.00333. eCollection 2019.
PubMed 31456995
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Stretching Interventions for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02766491
- Acronym / sponsor ID
- Stretching_CP_V1
- Conditions
- Cerebral Palsy
- Keywords
- Stretching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 May 2016 (estimated)
- 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.
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.
Detailed description
Cerebral palsy (CP) is a disorder resulting from a non-progressive lesion in the brain during pregnancy or early childhood. Children with CP show impaired movement patterns compared to typically developing (TD) children. One of the main factors limiting movement in children with CP is a reduced range of motion (ROM), which can be caused by a combination of neural and mechanical factors. Mechanical factors contributing to a reduced ROM are increased muscle/fascicle stiffness, reduced muscle length and changes in intramuscular tissue properties, all of which contribute to contractures.
Contractures are conservatively treated with stretching therapies, e.g., casting, night splints and physical therapy. However, they are very demanding for both children and parents, especially physical therapy which is painful and time-consuming. Therefore, when recommending stretching therapies, we need to assure they are efficacious. However, recent reviews show that the outcomes of stretching therapies in children with CP are highly variable.
Stretching interventions aim to improve ROM motion by increasing the overall length and/or lengthening properties of the muscle. To successfully achieve these adaptations, the muscle must experience adequate tensile stimulus during the intervention. However, it has been shown by previous studies examining muscle behaviour during stretch, that the muscle and fascicles in children with CP lengthen less than in TD children. Our own studies have confirmed this observations at the muscle, but also shown that the tendon in children with CP lengthens more during a stretch, than in TD children. These observations indicate that the higher stiffness of the target muscle relative to the in series tendon prevents the muscle fibres to experience a sufficiently large stretching stimulus, and the adaptations are small. Accordingly, in a recent study on long term stretching interventions it has been shown that muscle and fascicle strain increase, but no changes in the muscle's resting length or functional improvements have been found.
If you were to increase the stiffness of the tendon relative to the muscle prior to the stretching intervention, a greater stretching stimulus could be provided to the muscle. This would mean that for any given joint stretch the muscle will experience a greater portion of the stretch. It is well established in healthy adults and children that the stiffness of the tendon increases following resistance training. Given that well-designed resistance training is effective and safe for children with CP, the same increased tendon stiffness should follow gains in muscle strength in this group too. It is therefore hypothesise that a combined strengthening-stretching intervention would stiffen the tendon, increase the amount of stretch seen by the muscle, and thereby improve the effectiveness of stretching interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening and stretching | Experimental | Other: Strengthening and stretchingThe intervention group will follow a strengthening-stretching program of the calf muscles. |
| conventional stretching | Active comparator | Other: conventional stretchingThe control group will receive conventional stretching and strengthening exercises to the upper limb to assure that the same systemic physiological stimuli and a similar number of contact hours is received. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Strengthening and stretchingStrengthening exercises will be performed 4 times a week for 10 weeks. Single leg heel raises will be the preferred exercise performed. The group of participants will have a wide range of strength and functional abilities, this will be accounted for with individualised programmes. The exercise load can be reduced by switching to bilateral heel raises, giving external support, reducing the range of motion or performing the heel raises while seated. Exercise load will be progressively increased by adding weight in the form of water bottles to a rucksack worn on the participant's back. For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed. | Other | Strengthening and stretching |
| conventional stretchingThis group will perform seated biceps curls 4 times a week for 10 weeks, where extra load can be added progressively by holding water bottles in the hand. For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed. | Other | conventional stretching |
Primary outcome
Change Muscle fascicle length of the Gastrocnemius (mm)
Time frame: at baseline and after 10 weeks
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.
Change in Gastrocnemius muscle length (mm)
Time frame: at baseline and after 10 weeks
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.
6 secondary outcomes
Change in ankle range of motion (degree)
Time frame: at baseline and after 10 weeks
Change in Achilles tendon stiffness (Nm)
Time frame: at baseline, after 4 weeks and after 10 weeks
Change in maximal dorsiflexion angle during gait (degree)
Time frame: at baseline and after 10 weeks
Change in lengthening properties of the muscle fascicles (mm)
Time frame: at baseline and after 10 weeks
Changes in step length during gait (m)
Time frame: at baseline and after 10 weeks
Changes in ankle power at push of during gait
Time frame: at baseline and after 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Derived from this study: PubMed 31456995Kalkman BM, Holmes G, Bar-On L, Maganaris CN, Barton GJ, Bass A, Wright DM, Walton R, O'Brien TD. Resistance Training Combined With Stretching Increases Tendon Stiffness and Is More Effective Than Stretching Alone in Children With Cerebral Palsy: A Randomized Controlled Trial. Front Pediatr. 2019 Aug 13;7:333. doi: 10.3389/fped.2019.00333. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Thomas D O'Brien, PhD study director
Liverpool John Moores University
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening and stretching and conventional stretching in people with Cerebral Palsy, run by Liverpool John Moores University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara M Kalkman, Msc (07596722045, B.M.Kalkman@2014.ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Muscle fascicle length of the Gastrocnemius (mm) (time frame: at baseline and after 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766491, which also lists 1 linked publication.
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 9 May 2016; AzTrials last refreshed its copy on 31 Oct 2026.