Cerebral PalsyNCT01357954
The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy
A study testing Regular physiotherapy and Targeted Training in people with Cerebral Palsy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The project aims to test the effectiveness and explore the possibility of performing a novel therapeutic approach, targeting to increase strength and coordination around the trunk, giving a more active and functional seating and head control in those children with cerebral palsy (CP) who are wheelchair users. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Regular physiotherapy and Targeted Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Jun 2013
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of CP made by a neuro-pediatric physician experienced in assessment and diagnosis of CP
- GMFCS level III, IV and V,
- the child cannot walk without assistance,
- age 2-15 year,
- no joint deformity or contracture around the "Targeted" joint
- not a candidate for surgery or other medical treatment that affects motor skills while participating in the project
- trunk control problems.
Who cannot join
- uncontrolled epilepsy
- surgery within 12 months of the study start
- Botulinum toxin within 2 months of study start
- Lack of personnel resources to treat the child at their school/kindergarten
Trial locations and contacts
1 site in 1 country.
About this study
The project aims to test the effectiveness and explore the possibility of performing a novel therapeutic approach, targeting to increase strength and coordination around the trunk, giving a more active and functional seating and head control in those children with cerebral palsy (CP) who are wheelchair users. The project will also try to determine the muscle physiological effect of treatment using indirect measures of strength in the spinal musculature.
- Conditions
- Cerebral Palsy
- Being tested
- Regular physiotherapy, Targeted Training
- Keywords
- Postural control, Targeted Training, Gross motor function, Cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular physiotherapyOther
Also called Physiotherapy
The child's regular physiotherapy
Targeted TrainingOther
Also called The Movement Centre
Targeted training, 5 days a week for 6 months, up to 30 minutes a day
| Study group | Role | What they receive |
|---|---|---|
| Targeted Training | Experimental | Not described Receives: Other: Targeted Training |
| Control | Other | Not described Receives: Other: Regular physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Gross Motor Function Measure at 6 months
Measured: Baseline, 6 months
Secondary outcomes (9)
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months
Measured: Baseline, 6 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months
Measured: Baseline, 6 months
Change from baseline in seated sway at 6 months
Measured: Baseline, 6 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Measured: 6 months
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months
Measured: Baseline, 12 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months
Measured: Baseline, 12 months
Change from baseline in seated sway at 12 months
Measured: Baseline, 12 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Measured: 12 months
Change from baseline in Gross Motor Function Measure at 12 months
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Curtis, Hvidovre University Hospital
- Investigators
- Derek J Curtis, PT MSc, Principal investigator, Hvidovre University HospitalStig Sonne-Holm, Dr Med, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357954
- Sponsor's protocol ID
- HVH-DJC-1-2011
- Status last verified
- Aug 2020
- First submitted
- 6 May 2011
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01357954
- Acronym / sponsor ID
- HVH-DJC-1-2011
- Conditions
- Cerebral Palsy
- Keywords
- Postural control, Targeted Training, Gross motor function, Cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 May 2011 (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 project aims to test the effectiveness and explore the possibility of performing a novel therapeutic approach, targeting to increase strength and coordination around the trunk, giving a more active and functional seating and head control in those children with cerebral palsy (CP) who are wheelchair users. The project will also try to determine the muscle physiological effect of treatment using indirect measures of strength in the spinal musculature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Training | Experimental | Other: Targeted Training |
| Control | Other | Other: Regular physiotherapy |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- diagnosis of CP made by a neuro-pediatric physician experienced in assessment and diagnosis of CP
- GMFCS level III, IV and V,
- the child cannot walk without assistance,
- age 2-15 year,
- no joint deformity or contracture around the "Targeted" joint
Key exclusion criteria (4 listed)
- uncontrolled epilepsy
- surgery within 12 months of the study start
- Botulinum toxin within 2 months of study start
- Lack of personnel resources to treat the child at their school/kindergarten
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 |
|---|---|---|
| Regular physiotherapyAlso: PhysiotherapyThe child's regular physiotherapy | Other | Control |
| Targeted TrainingAlso: The Movement CentreTargeted training, 5 days a week for 6 months, up to 30 minutes a day | Other | Targeted Training |
Primary outcome
Change from baseline in Gross Motor Function Measure at 6 months
Time frame: Baseline, 6 months
9 secondary outcomes
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months
Time frame: Baseline, 6 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months
Time frame: Baseline, 6 months
Change from baseline in seated sway at 6 months
Time frame: Baseline, 6 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Time frame: 6 months
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months
Time frame: Baseline, 12 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months
Time frame: Baseline, 12 months
Change from baseline in seated sway at 12 months
Time frame: Baseline, 12 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Time frame: 12 months
Change from baseline in Gross Motor Function Measure at 12 months
Time frame: Baseline, 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 5 Aug 2020.
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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.
Derek J Curtis, PT MSc principal investigator
Hvidovre University Hospital
Stig Sonne-Holm, Dr Med study director
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular physiotherapy and Targeted Training in people with Cerebral Palsy, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 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 5 Aug 2020. 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 Denmark. 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 from baseline in Gross Motor Function Measure at 6 months (time frame: Baseline, 6 months). 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 5 Aug 2020.