Cerebral PalsyPhase 3NCT01633736
Targeted Hip Strength Training in Children With Cerebral Palsy (CP)
A Phase 3 study of Cerebral Palsy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study's main aim is to look at targeted strength training for muscles at the hips. Specifically to consider whether targeted strength training not only effects strength of the specific muscles but also ability to stand on one leg (single leg balance) as well as walking in children with cerebral palsy? This study… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Cerebral Palsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Mar 2013
- Phase
- Phase 3
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with CP aged between 7-16 years having sufficient cognition to undertake a strength training program
Who cannot join
- non-ambulation children or those unable to walk 5 meters independently (without walking aid),
- lower limb surgery within 12 months,
- botox within 6 months,
- oral muscle relaxant medication
- significant learning difficulty
- Any concurrent condition which would be contraindicated to progressive resistance training such as unmanaged high blood pressure, cardiac pathology or uncontrolled epilepsy
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- Where at baseline assessment finds no weakness in the muscles under investigation
- concurrent or within 6 months involvement in any other research study
- Non consent to General Practitioner (GP) notification.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Divison of Physiotherapy, School of Nursing, Midwifery and Physiotherapy, The University of Nottingham
Nottingham, Nottinghamshire, NG5 1PB
Grahame Pope, grahame.pope@nottingham.ac.uk
Sarah E Westwater-Wood
About this study
Official title: Targeted Hip Progressive Resistance Training to Improve Single Leg Balance and Walking in Children With Cerebral Palsy
This study's main aim is to look at targeted strength training for muscles at the hips. Specifically to consider whether targeted strength training not only effects strength of the specific muscles but also ability to stand on one leg (single leg balance) as well as walking in children with cerebral palsy? This study is a feasibility of method of investigation.
Read the detailed description
This study is focusing on functional change. The reasoning is that if the targeted strength training is effective at improving hip muscle contribution to stability then single leg balance may be improved. This may be functionally evident when weight bearing is taken by say the left leg in gait (percentage stance phase of gait) and as a consequence the opposing swing phase will be optimised as measured by stride. Thus the research question is does strengthening of the rotating and sideways moving hip muscles improve the walking of children with CP as measured by appropriate aspects of gait? Secondly, does this targeted strengthening also increase duration of single leg balance which is a simple easy to use measure in the community without the need for specialised equipment? The primary outcome measure will use a laboratory based 4 camera Codsmotion (CODA) biomechanical analysis system to measure stride (a) and percentage duration of stance phase of gait (b). Secondarily the duration of single leg balance in terms of seconds will be recorded. Gross motor functional and quality of life as also being assessed. The intervention is strengthening which will be implemented with the principles of progressive resistance training. Children with CP's therapists would ask for this type of intervention to be carried out
- Conditions
- Cerebral Palsy
- Being tested
- Usual care plus progresive resistance training
- Keywords
- single blinded, randomised, controlled, physiotherapy, children, 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.
Usual care plus progresive resistance trainingOther
Also called strength training
Duration 8 weeks; two weeks of familiarisation with the intervention protocol without resistance (for familiarisation and neural adaptation) followed by 6 weeks progressive resistance (PR). The three times a week PR training will be as a home exercise program with fortnightly home visits to monitor/progress PR training. It comprises a 4 minute warm up and cool down with one exercise targeting the hip abductors and one the lateral rotators. Exercise prescription will follow existing guidelines for progressive PR training. Parents will be taught supervision by the researcher using clear explanations in words and pictures in a logbook. Logbooks have been found to facilitate compliance, dosage and motivation.
| Study group | Role | What they receive |
|---|---|---|
| home progressive resistance exercise | Experimental | Not described Receives: Other: Usual care plus progresive resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameter
4 camera CODA gait analysis system for change in percentage stance phase of gait and stride in cm.
Measured: baseline, plus 8 weeks and plus 8 weeks (exit point)
Secondary outcomes (1)
Gross Motor Function Measure (GMFM)
To investigate any change in dimensions D and E of fucntioal activity with standardised GMFM.
Measured: Baseline, plus 8 weeks and plus 8 weeks (exit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grahame Pope, MPhil, BSc, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633736
- Sponsor's protocol ID
- UoN-SWW-2
- Status last verified
- Jul 2012
- First submitted
- 15 Jun 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cans, C., et al., Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. , in The Definition and Classification of Cerebral Palsy, P. Baxter, Editor. 2003, the SCPE collaborative group.
Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.
PubMed 12600249Hemming K, Hutton JL, Pharoah PO. Long-term survival for a cohort of adults with cerebral palsy. Dev Med Child Neurol. 2006 Feb;48(2):90-5. doi: 10.1017/S0012162206000211.
PubMed 16417662Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet. 2004 May 15;363(9421):1619-31. doi: 10.1016/S0140-6736(04)16207-7.
PubMed 15145637Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.
PubMed 16417071Parkes J, Donnelly M, Dolk H, Hill N. Use of physiotherapy and alternatives by children with cerebral palsy: a population study. Child Care Health Dev. 2002 Nov;28(6):469-77. doi: 10.1046/j.1365-2214.2002.00304.x.
PubMed 12568476Himpens E, Van den Broeck C, Oostra A, Calders P, Vanhaesebrouck P. Prevalence, type, distribution, and severity of cerebral palsy in relation to gestational age: a meta-analytic review. Dev Med Child Neurol. 2008 May;50(5):334-40. doi: 10.1111/j.1469-8749.2008.02047.x. Epub 2008 Mar 18.
PubMed 18355333Pallant, J (2001) SPSS Survival Manual. Edition 10, Open University Press, Buckingham.Philadelphia
Elder GC, Kirk J, Stewart G, Cook K, Weir D, Marshall A, Leahey L. Contributing factors to muscle weakness in children with cerebral palsy. Dev Med Child Neurol. 2003 Aug;45(8):542-50. doi: 10.1017/s0012162203000999.
PubMed 12882533Levitt, S., Treatment of Cerebral Palsy and Motor Delay. 3rd Edition ed. 1995: Blackwell Science.
Ross SA, Engsberg JR. Relation between spasticity and strength in individuals with spastic diplegic cerebral palsy. Dev Med Child Neurol. 2002 Mar;44(3):148-57. doi: 10.1017/s0012162201001852.
PubMed 12005315Scholtes VA, Dallmeijer AJ, Rameckers EA, Verschuren O, Tempelaars E, Hensen M, Becher JG. Lower limb strength training in children with cerebral palsy--a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles. BMC Pediatr. 2008 Oct 8;8:41. doi: 10.1186/1471-2431-8-41.
PubMed 18842125Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. doi: 10.1111/j.1469-8749.1998.tb15369.x.
PubMed 9489498Damiano DL, Kelly LE, Vaughn CL. Effects of quadriceps femoris muscle strengthening on crouch gait in children with spastic diplegia. Phys Ther. 1995 Aug;75(8):658-67; discussion 668-71. doi: 10.1093/ptj/75.8.658.
PubMed 7644570Tran, Q.T., Cerebral palsy; considerations for training. Strength and Conditioning Journal, 2005. 27(6): p. 34-38
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Hip Progressive Resistance Training to Improve Single Leg Balance and Walking in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01633736
- Acronym / sponsor ID
- UoN-SWW-2
- Conditions
- Cerebral Palsy
- Keywords
- single blinded, randomised, controlled, physiotherapy, children, cerebral palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 4 Jul 2012 (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.
This study's main aim is to look at targeted strength training for muscles at the hips. Specifically to consider whether targeted strength training not only effects strength of the specific muscles but also ability to stand on one leg (single leg balance) as well as walking in children with cerebral palsy? This study is a feasibility of method of investigation.
Detailed description
This study is focusing on functional change. The reasoning is that if the targeted strength training is effective at improving hip muscle contribution to stability then single leg balance may be improved. This may be functionally evident when weight bearing is taken by say the left leg in gait (percentage stance phase of gait) and as a consequence the opposing swing phase will be optimised as measured by stride. Thus the research question is does strengthening of the rotating and sideways moving hip muscles improve the walking of children with CP as measured by appropriate aspects of gait? Secondly, does this targeted strengthening also increase duration of single leg balance which is a simple easy to use measure in the community without the need for specialised equipment? The primary outcome measure will use a laboratory based 4 camera Codsmotion (CODA) biomechanical analysis system to measure stride (a) and percentage duration of stance phase of gait (b). Secondarily the duration of single leg balance in terms of seconds will be recorded. Gross motor functional and quality of life as also being assessed. The intervention is strengthening which will be implemented with the principles of progressive resistance training. Children with CP's therapists would ask for this type of intervention to be carried out
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| home progressive resistance exercise | Experimental | Other: Usual care plus progresive resistance training |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with CP aged between 7-16 years having sufficient cognition to undertake a strength training program
Key exclusion criteria (9 listed)
- non-ambulation children or those unable to walk 5 meters independently (without walking aid),
- lower limb surgery within 12 months,
- botox within 6 months,
- oral muscle relaxant medication
- significant learning difficulty
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 |
|---|---|---|
| Usual care plus progresive resistance trainingAlso: strength trainingDuration 8 weeks; two weeks of familiarisation with the intervention protocol without resistance (for familiarisation and neural adaptation) followed by 6 weeks progressive resistance (PR). The three times a week PR training will be as a home exercise program with fortnightly home visits to monitor/progress PR training. It comprises a 4 minute warm up and cool down with one exercise targeting the hip abductors and one the lateral rotators. Exercise prescription will follow existing guidelines for progressive PR training. Parents will be taught supervision by the researcher using clear explanations in words and pictures in a logbook. Logbooks have been found to facilitate compliance, dosage and motivation. | Other | home progressive resistance exercise |
Primary outcome
Gait parameter
Time frame: baseline, plus 8 weeks and plus 8 weeks (exit point)
4 camera CODA gait analysis system for change in percentage stance phase of gait and stride in cm.
1 secondary outcome
Gross Motor Function Measure (GMFM)
Time frame: Baseline, plus 8 weeks and plus 8 weeks (exit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
- BackgroundCans, C., et al., Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. , in The Definition and Classification of Cerebral Palsy, P. Baxter, Editor. 2003, the SCPE collaborative group.
- Background: PubMed 12600249Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.
- Background: PubMed 16417662Hemming K, Hutton JL, Pharoah PO. Long-term survival for a cohort of adults with cerebral palsy. Dev Med Child Neurol. 2006 Feb;48(2):90-5. doi: 10.1017/S0012162206000211.
- Background: PubMed 15145637Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet. 2004 May 15;363(9421):1619-31. doi: 10.1016/S0140-6736(04)16207-7.
- Background: PubMed 16417071Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.
- Background: PubMed 12568476Parkes J, Donnelly M, Dolk H, Hill N. Use of physiotherapy and alternatives by children with cerebral palsy: a population study. Child Care Health Dev. 2002 Nov;28(6):469-77. doi: 10.1046/j.1365-2214.2002.00304.x.
- Background: PubMed 18355333Himpens E, Van den Broeck C, Oostra A, Calders P, Vanhaesebrouck P. Prevalence, type, distribution, and severity of cerebral palsy in relation to gestational age: a meta-analytic review. Dev Med Child Neurol. 2008 May;50(5):334-40. doi: 10.1111/j.1469-8749.2008.02047.x. Epub 2008 Mar 18.
- BackgroundPallant, J (2001) SPSS Survival Manual. Edition 10, Open University Press, Buckingham.Philadelphia
- Background: PubMed 12882533Elder GC, Kirk J, Stewart G, Cook K, Weir D, Marshall A, Leahey L. Contributing factors to muscle weakness in children with cerebral palsy. Dev Med Child Neurol. 2003 Aug;45(8):542-50. doi: 10.1017/s0012162203000999.
- BackgroundLevitt, S., Treatment of Cerebral Palsy and Motor Delay. 3rd Edition ed. 1995: Blackwell Science.
- Background: PubMed 12005315Ross SA, Engsberg JR. Relation between spasticity and strength in individuals with spastic diplegic cerebral palsy. Dev Med Child Neurol. 2002 Mar;44(3):148-57. doi: 10.1017/s0012162201001852.
- Background: PubMed 18842125Scholtes VA, Dallmeijer AJ, Rameckers EA, Verschuren O, Tempelaars E, Hensen M, Becher JG. Lower limb strength training in children with cerebral palsy--a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles. BMC Pediatr. 2008 Oct 8;8:41. doi: 10.1186/1471-2431-8-41.
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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.
Grahame Pope, MPhil, BSc principal investigator
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Cerebral Palsy, run by University of Nottingham at 1 site in United Kingdom.
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 1 inclusion and 9 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 4 Jul 2012. 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 Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sarah E Westwater-Wood, MMedSci, BSc (+44 115 8231793, sarah.westwater-wood@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameter (time frame: baseline, plus 8 weeks and plus 8 weeks (exit point)). 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 NCT01633736, which also lists 45 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 4 Jul 2012.