Spastic Cerebral PalsyNCT01815814
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
A study testing Rolfing / Myofascial Structural Integration in people with Spastic Cerebral Palsy, run by Stanford University at 1 site in United States.
Trial summary
The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment… Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Rolfing / Myofascial Structural Integration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Nov 2014
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 1 up to, but not including, 7 years of age
- Children having the diagnosis of spastic cerebral palsy
- Children who have spasticity in one or both upper or lower limbs
- Children who are classified as either Gross Motor Function Classification System (GMFCS) level 2, 3 or 4 or Manual Ability Classification System (MACS) level 2, 3, 4 or 5
Who cannot join
- Children with active seizure disorders
- Children taking more than one medication to control their seizures
- Children with severe health problems that could be exacerbated by the treatment (such as severe chronic lung disease)
- Children who have undergone surgical treatments or botulinum injections within 6 months of entering the study
- Children who have planned surgical interventions during the studies time course
- Children with sensory, cognitive or language deficits which would affect their ability to understand directions necessary for assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment waiting period.
The investigators further hypothesize that children with spastic CP will maintain their gains in gross motor function for ≥ 3 months after completion of MSI treatment.
Read the detailed description
- The investigators will talk to you by telephone to determine if your child is eligible for the study.
- The study lasts for a total of 12 months with the massage treatment period lasting 12 weeks.
- The study entails a total of 10 sessions of Myofascial Structural Integration therapy over the 12-week period. Each session will last one hour.
- The child will have an evaluation of motor functions and development on enrollment and at three-month intervals for a total of 5 evaluations.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Rolfing / Myofascial Structural Integration
- Keywords
- spasticity, cerebral palsy, hemiplegia, hemiparesis, diplegia, paraplegia, quadriplegia, quadriparesis
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Hemiplegia, Paresis, Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rolfing / Myofascial Structural IntegrationOther
Rolfing is similar to deep massage. It is also known as "myofascial structural integration."
| Study group | Role | What they receive |
|---|---|---|
| Rolfing After 3-Month Wait | Experimental | The children in this arm receive the therapy (rolfing / myofascial structural integration) 3 months after they start the study. Receives: Other: Rolfing / Myofascial Structural Integration |
| Rolfing After 6-Month Wait | Other | The children in this arm receive the therapy (rolfing / myofascial structural integration) 6 months after they start the study. Receives: Other: Rolfing / Myofascial Structural Integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure Score
Measured: at Enrollment and every 3 months thereafter for up to 12 months
Secondary outcomes (1)
Change in GAITRite Mat Measures
Measured: at Enrollment and every 3 months thereafter for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionNov 2014
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 Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Heidi M. Feldman, Stanford University
- Investigators
- Heidi M Feldman, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815814
- Sponsor's protocol ID
- 104644
- Other IDs
- 16807
- Status last verified
- May 2015
- First submitted
- 19 Mar 2013
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen AB, Price KS, Feldman HM. Myofascial structural integraton: A promising complementary therapy for young children with spastic cerebral palsy. Journal of Evidence-Based Complementary and Alternative Medicine 17: 131-135, 2012
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01815814
- Acronym / sponsor ID
- 104644
- Conditions
- Spastic Cerebral Palsy
- Keywords
- spasticity, cerebral palsy, hemiplegia, hemiparesis, diplegia, paraplegia, quadriplegia, quadriparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Mar 2013 (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.
The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment waiting period.
The investigators further hypothesize that children with spastic CP will maintain their gains in gross motor function for ≥ 3 months after completion of MSI treatment.
Detailed description
- The investigators will talk to you by telephone to determine if your child is eligible for the study.
- The study lasts for a total of 12 months with the massage treatment period lasting 12 weeks.
- The study entails a total of 10 sessions of Myofascial Structural Integration therapy over the 12-week period. Each session will last one hour.
- The child will have an evaluation of motor functions and development on enrollment and at three-month intervals for a total of 5 evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rolfing After 3-Month Wait | Experimental | Other: Rolfing / Myofascial Structural IntegrationThe children in this arm receive the therapy (rolfing / myofascial structural integration) 3 months after they start the study. |
| Rolfing After 6-Month Wait | Other | Other: Rolfing / Myofascial Structural IntegrationThe children in this arm receive the therapy (rolfing / myofascial structural integration) 6 months after they start the study. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children from 1 up to, but not including, 7 years of age
- Children having the diagnosis of spastic cerebral palsy
- Children who have spasticity in one or both upper or lower limbs
- Children who are classified as either Gross Motor Function Classification System (GMFCS) level 2, 3 or 4 or Manual Ability Classification System (MACS) level 2, 3, 4 or 5
Key exclusion criteria (6 listed)
- Children with active seizure disorders
- Children taking more than one medication to control their seizures
- Children with severe health problems that could be exacerbated by the treatment (such as severe chronic lung disease)
- Children who have undergone surgical treatments or botulinum injections within 6 months of entering the study
- Children who have planned surgical interventions during the studies time course
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 |
|---|---|---|
| Rolfing / Myofascial Structural IntegrationRolfing is similar to deep massage. It is also known as "myofascial structural integration." | Other | Rolfing After 3-Month Wait, Rolfing After 6-Month Wait |
Primary outcome
Change in Gross Motor Function Measure Score
Time frame: at Enrollment and every 3 months thereafter for up to 12 months
1 secondary outcome
Change in GAITRite Mat Measures
Time frame: at Enrollment and every 3 months thereafter for up to 12 months
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 8 Jul 2015.
- BackgroundHansen AB, Price KS, Feldman HM. Myofascial structural integraton: A promising complementary therapy for young children with spastic cerebral palsy. Journal of Evidence-Based Complementary and Alternative Medicine 17: 131-135, 2012
Related trials for Spastic Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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.
Heidi M Feldman, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rolfing / Myofascial Structural Integration in people with Spastic Cerebral Palsy, run by Stanford University at 1 site in United States.
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 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 8 Jul 2015. 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 United States. 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 Gross Motor Function Measure Score (time frame: at Enrollment and every 3 months thereafter for up to 12 months). 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 NCT01815814, 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 8 Jul 2015.