Cerebral Palsy, SpasticNCT04570358
Stretching in Children and Adolescents With Spastic Cerebral Palsy
A study testing Static stretching and Proprioceptive neuromuscular facilitation stretching in people with Cerebral Palsy, Spastic, run by University of Graz at 1 site in Austria.
Trial summary
The primary aim of this study is to gain knowledge about both the effects of a single bout of static and proprioceptive neuromuscular facilitation (PNF) stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with spastic cerebral palsy (SCP). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Static stretching and Proprioceptive neuromuscular facilitation stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- 11 Sep 2020to 23 Sep 2021
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- spastic cerebral palsy
- ambulatory children and adolescents
- ability to accept and follow verbal instructions
- no severe contracture of the calf muscles (max. ankle dorsiflexion >= 0°, with knees extended)
- classified as GMFCS level I, II, or III
- aged between 6 and 5 years
- willingness to participate
Who cannot join
- others than spastic forms of cerebral palsy
- severe mental retardation
- fixed muscle contractures (ankle equinus deformity = max. ankle dorsiflexion <= 0°, with knees extended)
- oral anti-spastic and/or muscle relaxation medication in the last 6 months
- orthopaedic surgery and/or Botulinum toxin type A application in the last 12 months
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute of Human Movement Science, Sport and Health; University of Graz
Graz, 8010
About this study
Official title: Stretching in Children With Spastic Cerebral Palsy
The primary aim of this study is to gain knowledge about both the effects of a single bout of static and proprioceptive neuromuscular facilitation (PNF) stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with spastic cerebral palsy (SCP). Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes.
Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle.
Read the detailed description
Background: Spastic cerebral palsy (SCP) is a non-progressive neuro-muscular disorder in children resulting from an injury in the central nervous system. Individuals with SCP present with impairments such as hyperreflexia, demonstrate impaired motor control and muscle growth. Manual stretching is an important approach in the physical therapy of individuals with SCP used to increase muscle extensibility and length, decrease muscle stiffness, and to improve functional abilities. However, there are only a few studies that have examined its acute and long-term effects in children with SCP and it is still not clear, if it may lead to the expected changes, and which method might be the most-effective one. Besides static stretching, proprioceptive neuromuscular facilitation (PNF) stretching has been used to aid the rehabilitation of, for example, stroke patients by either facilitating muscle elongation and/or improving muscle strength. Positive effects were found (e.g., increased dorsiflexion, improved gait function, altered tendon properties), which are also clinically relevant for individuals with SCP. However, there is no information about the impact of PNF in this population.
Aims: The primary aim of this study is to gain knowledge about both the effects of a single bout of static and PNF stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with SCP. Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes. Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle-tendon unit.
Methods: A randomized controlled trial with a cross-over design will be performed. Prior to the measurements, a familiarization session takes place and both groups will further be examined in three separate measurement sessions. Based on a power calculation and in order to account for possible dropouts, 30 individuals with SCP (age range: 6 to 15 years) will be recruited. The participants will be randomly allocated to either the static stretching or PNF stretching intervention after the familiarization session. Passive muscle-tendon morphological properties will be examined. A manually controlled instrumented spasticity assessment will be performed to test for differences in the reflex responses. Information about the lengthening behavior of the tissues throughout the dorsiflexion rotations will also be collected by use of ultrasound. Isometric muscle strength and the active torque-angle relationship will be investigated using an isokinetic dynamometer. To assess the gait pattern of the children, a gait analysis will be performed by use of an 8-camera motion capture system. In addition, we will examine the participants' gait function and functional performance by use of the Gait Outcomes Assessment List questionnaire.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Static stretching, Proprioceptive neuromuscular facilitation stretching
- Keywords
- Cerebral palsy, Stretching, Muscle-tendon unit, Spasticity, Gait
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static stretchingOther
During the static stretching training for the calf muscles, the ankle joint is moved into maximal dorsiflexion until the point of discomfort is reached. The ankle joint is then held in this maximal position for 30 s followed by a rest period of 30 s. Afterwards, the procedure is repeated with the knee in flexed position to stretch the soleus muscle.
Proprioceptive neuromuscular facilitation stretchingOther
Also called PNF
During the proprioceptive neuromuscular facilitation stretching, the ankle joint is moved into maximal dorsiflexion. While the foot is kept in this position, the child will perform a (sub-) maximal isometric contraction of the plantar flexors against the resistance of their parents. Afterwards, the ankle joint will be moved further into greater dorsiflexion and is held there for the remaining seconds followed by 30 s of rest. Subsequently, the stretch will be applied with the knee flexed.
| Study group | Role | What they receive |
|---|---|---|
| Static stretching | Experimental | An 8-week home-based static stretching training for the calf muscles will be performed by group A. Altogether, 10 stretches are performed per leg 4 times a week. Receives: Other: Static stretching |
| Control | No intervention | While group A performs the 8-week static stretching training, group B acts as control group performing its daily life activities as usual. |
| Proprioceptive neuromuscular facilitation stretching | Experimental | After group A has finished the 8-week static stretching training, group B starts with the 8-week home-based proprioceptive neuromuscular facilitation stretching training. Altogether, 10 stretches are performed per leg 4 times a week. Receives: Other: Proprioceptive neuromuscular facilitation stretching |
| Follow-up | No intervention | While group B performs the 8-week proprioceptive neuromuscular facilitation stretching, group A is in its follow-up period performing its daily life activities as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mechano-morphological muscle-tendon properties
Gastrocnemius medialis muscle morphology, muscle stiffness, tendon-aponeurosis length and stiffness, muscle-tendon unit length and stiffness, elongations of the tissues
Measured: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in spasticity/stretch hyperreflexia
Stretch reflex responses assessed by a manually controlled instrumented spasticity assessment
Measured: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in joint range of motion
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Measured: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in active moment-angle relationship
Maximum isometric voluntary contractions at specific ankle joint angles (isokinetic dynamometry)
Measured: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Secondary outcomes (3)
Change in gait characteristics
Gait kinematics of the hip, knee, and ankle joints, gait kinetics (3D motion capture)
Measured: familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in self-reported gait, mobility, and functional performance
Gait Outcomes Assessment List (GOAL) questionnaire
Measured: familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in maximal isometric muscle strength
Maximal isometric torque production (isokinetic dynamometry)
Measured: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start11 Sep 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Principal investigator, Dr. Annika Kruse, University of Graz
- Investigators
- Annika Kruse, Dr.rer.nat., Principal investigator, University of Graz, Institute of Human Movement Science, Sport and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570358
- Sponsor's protocol ID
- T1017
- Other IDs
- T1017-B27
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2020
- Last updated
- 12 Oct 2021
- 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.
Publications
Lee WY, Park GY, Kwon DR. Comparison of treatment effects between children with spastic cerebral palsy under and over five years after botulinum toxin type a injection. Ann Rehabil Med. 2014 Apr;38(2):200-8. doi: 10.5535/arm.2014.38.2.200. Epub 2014 Apr 29.
PubMed 24855614Willerslev-Olsen M, Choe Lund M, Lorentzen J, Barber L, Kofoed-Hansen M, Nielsen JB. Impaired muscle growth precedes development of increased stiffness of the triceps surae musculotendinous unit in children with cerebral palsy. Dev Med Child Neurol. 2018 Jul;60(7):672-679. doi: 10.1111/dmcn.13729. Epub 2018 Mar 24.
PubMed 29573407Barber L, Barrett R, Lichtwark G. Medial gastrocnemius muscle fascicle active torque-length and Achilles tendon properties in young adults with spastic cerebral palsy. J Biomech. 2012 Oct 11;45(15):2526-30. doi: 10.1016/j.jbiomech.2012.07.018. Epub 2012 Aug 3.
PubMed 22867763Wiart L, Darrah J, Kembhavi G. Stretching with children with cerebral palsy: what do we know and where are we going? Pediatr Phys Ther. 2008 Summer;20(2):173-8. doi: 10.1097/PEP.0b013e3181728a8c.
PubMed 18480717Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. doi: 10.2165/00007256-200636110-00002.
PubMed 17052131Zhou Z, Sun Y, Wang N, Gao F, Wei K, Wang Q. Robot-Assisted Rehabilitation of Ankle Plantar Flexors Spasticity: A 3-Month Study with Proprioceptive Neuromuscular Facilitation. Front Neurorobot. 2016 Nov 14;10:16. doi: 10.3389/fnbot.2016.00016. eCollection 2016.
PubMed 27895574Zhou Z, Zhou Y, Wang N, Gao F, Wang L, Wei K, Wang Q. Changes of Achilles tendon properties via 12-week PNF based robotic rehabilitation of ankle joints with spasticity and/or contracture. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1214-7. doi: 10.1109/EMBC.2014.6943815.
PubMed 25570183Kruse A, Habersack A, Weide G, Jaspers RT, Svehlik M, Tilp M. Eight weeks of proprioceptive neuromuscular facilitation stretching and static stretching do not affect muscle-tendon properties, muscle strength, and joint function in children with spastic cerebral palsy. Clin Biomech (Bristol). 2023 Jul;107:106011. doi: 10.1016/j.clinbiomech.2023.106011. Epub 2023 Jun 7.
PubMed 37329655
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stretching in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04570358
- Acronym / sponsor ID
- T1017
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral palsy, Stretching, Muscle-tendon unit, Spasticity, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GrazUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 30 Sep 2020 (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.
The primary aim of this study is to gain knowledge about both the effects of a single bout of static and proprioceptive neuromuscular facilitation (PNF) stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with spastic cerebral palsy (SCP). Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes.
Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle.
Detailed description
Background: Spastic cerebral palsy (SCP) is a non-progressive neuro-muscular disorder in children resulting from an injury in the central nervous system. Individuals with SCP present with impairments such as hyperreflexia, demonstrate impaired motor control and muscle growth. Manual stretching is an important approach in the physical therapy of individuals with SCP used to increase muscle extensibility and length, decrease muscle stiffness, and to improve functional abilities. However, there are only a few studies that have examined its acute and long-term effects in children with SCP and it is still not clear, if it may lead to the expected changes, and which method might be the most-effective one. Besides static stretching, proprioceptive neuromuscular facilitation (PNF) stretching has been used to aid the rehabilitation of, for example, stroke patients by either facilitating muscle elongation and/or improving muscle strength. Positive effects were found (e.g., increased dorsiflexion, improved gait function, altered tendon properties), which are also clinically relevant for individuals with SCP. However, there is no information about the impact of PNF in this population.
Aims: The primary aim of this study is to gain knowledge about both the effects of a single bout of static and PNF stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with SCP. Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes. Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle-tendon unit.
Methods: A randomized controlled trial with a cross-over design will be performed. Prior to the measurements, a familiarization session takes place and both groups will further be examined in three separate measurement sessions. Based on a power calculation and in order to account for possible dropouts, 30 individuals with SCP (age range: 6 to 15 years) will be recruited. The participants will be randomly allocated to either the static stretching or PNF stretching intervention after the familiarization session. Passive muscle-tendon morphological properties will be examined. A manually controlled instrumented spasticity assessment will be performed to test for differences in the reflex responses. Information about the lengthening behavior of the tissues throughout the dorsiflexion rotations will also be collected by use of ultrasound. Isometric muscle strength and the active torque-angle relationship will be investigated using an isokinetic dynamometer. To assess the gait pattern of the children, a gait analysis will be performed by use of an 8-camera motion capture system. In addition, we will examine the participants' gait function and functional performance by use of the Gait Outcomes Assessment List questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Static stretching | Experimental | Other: Static stretchingAn 8-week home-based static stretching training for the calf muscles will be performed by group A. Altogether, 10 stretches are performed per leg 4 times a week. |
| Control | No intervention | –While group A performs the 8-week static stretching training, group B acts as control group performing its daily life activities as usual. |
| Proprioceptive neuromuscular facilitation stretching | Experimental | Other: Proprioceptive neuromuscular facilitation stretchingAfter group A has finished the 8-week static stretching training, group B starts with the 8-week home-based proprioceptive neuromuscular facilitation stretching training. Altogether, 10 stretches are performed per leg 4 times a week. |
| Follow-up | No intervention | –While group B performs the 8-week proprioceptive neuromuscular facilitation stretching, group A is in its follow-up period performing its daily life activities as usual. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- spastic cerebral palsy
- ambulatory children and adolescents
- ability to accept and follow verbal instructions
- no severe contracture of the calf muscles (max. ankle dorsiflexion >= 0°, with knees extended)
- classified as GMFCS level I, II, or III
Key exclusion criteria (5 listed)
- others than spastic forms of cerebral palsy
- severe mental retardation
- fixed muscle contractures (ankle equinus deformity = max. ankle dorsiflexion <= 0°, with knees extended)
- oral anti-spastic and/or muscle relaxation medication in the last 6 months
- orthopaedic surgery and/or Botulinum toxin type A application 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 |
|---|---|---|
| Static stretchingDuring the static stretching training for the calf muscles, the ankle joint is moved into maximal dorsiflexion until the point of discomfort is reached. The ankle joint is then held in this maximal position for 30 s followed by a rest period of 30 s. Afterwards, the procedure is repeated with the knee in flexed position to stretch the soleus muscle. | Other | Static stretching |
| Proprioceptive neuromuscular facilitation stretchingAlso: PNFDuring the proprioceptive neuromuscular facilitation stretching, the ankle joint is moved into maximal dorsiflexion. While the foot is kept in this position, the child will perform a (sub-) maximal isometric contraction of the plantar flexors against the resistance of their parents. Afterwards, the ankle joint will be moved further into greater dorsiflexion and is held there for the remaining seconds followed by 30 s of rest. Subsequently, the stretch will be applied with the knee flexed. | Other | Proprioceptive neuromuscular facilitation stretching |
Primary outcome
Change in mechano-morphological muscle-tendon properties
Time frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Gastrocnemius medialis muscle morphology, muscle stiffness, tendon-aponeurosis length and stiffness, muscle-tendon unit length and stiffness, elongations of the tissues
Change in spasticity/stretch hyperreflexia
Time frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Stretch reflex responses assessed by a manually controlled instrumented spasticity assessment
Change in joint range of motion
Time frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Change in active moment-angle relationship
Time frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Maximum isometric voluntary contractions at specific ankle joint angles (isokinetic dynamometry)
3 secondary outcomes
Change in gait characteristics
Time frame: familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in self-reported gait, mobility, and functional performance
Time frame: familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in maximal isometric muscle strength
Time frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 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 12 Oct 2021.
- Background: PubMed 24855614Lee WY, Park GY, Kwon DR. Comparison of treatment effects between children with spastic cerebral palsy under and over five years after botulinum toxin type a injection. Ann Rehabil Med. 2014 Apr;38(2):200-8. doi: 10.5535/arm.2014.38.2.200. Epub 2014 Apr 29.
- Background: PubMed 29573407Willerslev-Olsen M, Choe Lund M, Lorentzen J, Barber L, Kofoed-Hansen M, Nielsen JB. Impaired muscle growth precedes development of increased stiffness of the triceps surae musculotendinous unit in children with cerebral palsy. Dev Med Child Neurol. 2018 Jul;60(7):672-679. doi: 10.1111/dmcn.13729. Epub 2018 Mar 24.
- Background: PubMed 22867763Barber L, Barrett R, Lichtwark G. Medial gastrocnemius muscle fascicle active torque-length and Achilles tendon properties in young adults with spastic cerebral palsy. J Biomech. 2012 Oct 11;45(15):2526-30. doi: 10.1016/j.jbiomech.2012.07.018. Epub 2012 Aug 3.
- Background: PubMed 18480717Wiart L, Darrah J, Kembhavi G. Stretching with children with cerebral palsy: what do we know and where are we going? Pediatr Phys Ther. 2008 Summer;20(2):173-8. doi: 10.1097/PEP.0b013e3181728a8c.
- Background: PubMed 17052131Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. doi: 10.2165/00007256-200636110-00002.
- Background: PubMed 27895574Zhou Z, Sun Y, Wang N, Gao F, Wei K, Wang Q. Robot-Assisted Rehabilitation of Ankle Plantar Flexors Spasticity: A 3-Month Study with Proprioceptive Neuromuscular Facilitation. Front Neurorobot. 2016 Nov 14;10:16. doi: 10.3389/fnbot.2016.00016. eCollection 2016.
- Background: PubMed 25570183Zhou Z, Zhou Y, Wang N, Gao F, Wang L, Wei K, Wang Q. Changes of Achilles tendon properties via 12-week PNF based robotic rehabilitation of ankle joints with spasticity and/or contracture. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1214-7. doi: 10.1109/EMBC.2014.6943815.
- Derived from this study: PubMed 37329655Kruse A, Habersack A, Weide G, Jaspers RT, Svehlik M, Tilp M. Eight weeks of proprioceptive neuromuscular facilitation stretching and static stretching do not affect muscle-tendon properties, muscle strength, and joint function in children with spastic cerebral palsy. Clin Biomech (Bristol). 2023 Jul;107:106011. doi: 10.1016/j.clinbiomech.2023.106011. Epub 2023 Jun 7.
- 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.
Annika Kruse, Dr.rer.nat. principal investigator
University of Graz, Institute of Human Movement Science, Sport and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static stretching and Proprioceptive neuromuscular facilitation stretching in people with Cerebral Palsy, Spastic, run by 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 7 inclusion and 5 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 12 Oct 2021. 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 (time frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)). The study lists 4 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 NCT04570358, which also lists 8 linked publications.
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 12 Oct 2021.