Cerebral PalsyNCT02141802
Clinical Effectiveness of Increased Standing Time in Non-ambulant Children With Cerebral Palsy:a Pilot Study
A study testing Doubling standing time in people with Cerebral Palsy and Developmental Delay, run by Rachel Rapson at 4 sites in United Kingdom.
Trial summary
Children with cerebral palsy commonly use standing frames to position them to help prevent contracture and deformity and to help their function. There is a lack of evidence to support the correct dosage of standing frame use. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Cerebral Palsy, Developmental Delay
- What is being tested?
- Doubling standing time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 May 2014to 1 Oct 2018
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of cerebral palsy or developmental delay
- Aged between 1-12 years at the beginning of the study
- Signs UMN involvement with spasticity or hypertonia in at least one limb
- Gross motor function classification III-V
- undertaking a standing programme of at least 1.5hours per week for at least a month
Who cannot join
- Soft tissue release that would require imobilization which would prevent standing within 6 months from the onset of the trial
- Bony surgery Soft that would require imobilization which would prevent standing within 12 months from the onset of the trial
- a fracture that would prevent standing
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Honeylands Specialist Child Assessment Centre
Exeter, EX4 8AD
Child Development centre
Plymouth Devon, PL2 2PQ
John Parkes Unit Newton Road
Torbay
Royal Cornwall Hspitals Trust
Truro, Cornwall
About this study
Children with cerebral palsy commonly use standing frames to position them to help prevent contracture and deformity and to help their function. There is a lack of evidence to support the correct dosage of standing frame use.
The aim of this study is to pilot a randomised controlled trial of the clinical effects of doubling the duration of standing, using standing frames, in young children who are unable to walk, who have cerebral palsy or developmental delay.
Read more
It will determine whether it is feasable to carry out a multi-centred trial.
The study objectives will be to determine:
- presence of adverse events
- recruitment and drop out rate
- compliance with the intervention
- feasibility of the randomisation and minimisation process
- the proportion of the outcome measures taken
- effect size estimate
- required study costs
- effectiveness of blinding procedure
Read the detailed description
Thirty non-ambulant children with cerebral palsy will be randomised into one of two groups that either (a) maintains the child's current standing frame program- the control group (n=15) (b) doubles the standing time- the intervention group (n=15). Outcome measures will be taken at baseline and at 6 monthly intervals by a blinded assessor.
Research process and flow Families who are willing to participate in the study will be provided with a diary sheet that will allow them to record over a baseline 2 week period how frequently their child stood and in what position. The diary sheet will be available in word or hard copy format. An e mail/ stamped addressed envelope will be provided to return the diary at the end of 2 weeks. Participants will be reminded via text/ phone / e mail (depending on their preferred method of communication) after 1 week if they have not returned their diary sheets.
On receipt of the diary sheets participants will be randomized into an intervention or control group (see below). A therapist will explain the group allocation to the families at their home or their local CDC. The trial will run for 12 months with the outcome measures being taken by an assessor blinded to group allocation. The primary outcome measure (hip migration percentage) will be taken at 0 and 12 months so as to fit in with practice across the South West and not to increase x ray exposure. The secondary outcome measures will be taken at baseline, 6 and 12 months. The final RCT will involve a 3 yr follow-up phase.
Sample Size We aim to recruit 15 people per group. An audit of CDC records suggests that there are between 5-6 eligible participants over a 12 month recruitment period. With 8 main recruitment centres this would result in 40-48 potential participants and a required recruitment rate of 75-63%. An on-going study looking at walking in children with older children with CP at Plymouth University suggests that this recruitment rate is feasible. Determining the actual recruitment rate in this particular patient population and the feasibility of using multiple centres across one region is one objective of the pilot study.
Randomisation
Thirty children with Cerebral Palsy (age 1-12 yrs; GMFCS III-V) will be recruited from South West based services. Participants will be randomly allocated to the intervention or control using a web-based system. A minimisation algorithm will be used to ensure balance between the groups on the basis of the following:
- Age (<6 yrs Vs >6 yrs)
- Functional ability (GMFCS=III or IVs GMFCS =V)
- Baseline standing time (<30 mins Vs >30 mins)
Intervention All participants will already be performing a standing regime as prescribed by their treating therapist. The study design and group allocation will be explained by the research assistant (RA1) either at the local CDC or at the participants' home. The control group will continue their usual standing-frame based regime. The intervention group will double their daily standing-frame time.
In both groups a guidance sheet will be provided about how to progress their standing time for the duration of the trial by 10%/month up to a maximum of 1 hr/day in the control group and 2 hr/day in the intervention group. Following PPI advice the guidance will be personalised to include photos of how to set their child up in their own standing frame and the correct position of supportive straps / correct posture to adopt.
The research assistant will visit both groups at the start of the trial and every 3 months. At each visit they will (a) check the position the child adopts in the standing frame (b) check footwear and splints for use and fit (c) check the progression of treatment (d) check and record any changes to their additional care routine by the treating therapist. Feedback about problems in footwear / splinting will be passed onto the child's treating therapist.
Outcome Measures The primary outcome measure will be taken at baseline (0 months) and at 12 months. This fits in with routine practice cross all centres in the South West although some centres take additional x-rays at 6 months. All other measures will be taken at 0, 6 and 12 months. Outcomes will be measured by an assessor blinded to the group allocation.
- Conditions
- Cerebral Palsy, Developmental Delay
- Being tested
- Doubling standing time, control
- Medical subject headings
- Cerebral Palsy, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doubling standing timeBehavioural
Doubling standing time using child's previously prescribed standing frame with a progression of 10% increase in time/month up to 2 hrs/day maximum
controlBehavioural
Continue with usual standing time with a progression of 10% increase in time/month up to 1 hr/day maximum
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Normal standing time Receives: Behavioral: control |
| Doubling standing time | Experimental | Doubled standing time calculated by doubling baseline standing time Receives: Behavioral: Doubling standing time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip migration Percentage
In line with planned hip screening, not additional x rays.
Measured: baseline and 12 months
Secondary outcomes (8)
Standing time
By use of a daily diary
Measured: weekly over 12 months
Muscle length
gastrocnemius, hamstrings and hip flexors
Measured: 0, 6 months and 12 months
Rectus femoris circumference using ultrasound
1/3rd distance from proximal patella to ASIS. 3x cross section and 3 x longitudinal images taken and mean scores derived.
Measured: 0, 6, 12 months
Muscle tone hip flexors hamstrings and ankle plantarflexors Tardieu test
3 range of movements at 100 degrees per second mean scores calculated
Measured: 0, 6, 12 months
Muscle tone of gastrocnemius using the myotonometer
Muscle tap x 3 medial head of gastrocnemius at mid way between medial malleolus and head of the fibula. Mean score taken.
Measured: 0, 6, 12 months
Paediatric pain profile
parent reported structured score sheet
Measured: 0, 6 12 months
Gross motor function measure
standardised assessment GMFM66
Measured: 0, 6, 12 months
CP CHILD questionnaire
parent reported questionairre
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study start1 May 2014
- Primary completion30 Apr 2018
- Study completion1 Oct 2018
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachel Rapson
- Sponsor type
- University, hospital or other
- Collaborators
- University of Plymouth
- Responsible party
- Sponsor-investigator, Rachel Rapson, University of Plymouth
- Investigators
- Jonathan Marsden, Phd, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141802
- Sponsor's protocol ID
- REC 13/SW/0228
- Status last verified
- Nov 2018
- First submitted
- 15 May 2014
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Increased Standing Time in Non-ambulant Children With Cerebral Palsy:a Pilot Study
- ClinicalTrials.gov ID
- NCT02141802
- Acronym / sponsor ID
- REC 13/SW/0228
- Conditions
- Cerebral Palsy, Developmental Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rachel RapsonUniversity, hospital or other
- Collaborators
- University of Plymouth
- Study start
- 1 May 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 19 May 2014 (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.
Children with cerebral palsy commonly use standing frames to position them to help prevent contracture and deformity and to help their function. There is a lack of evidence to support the correct dosage of standing frame use.
The aim of this study is to pilot a randomised controlled trial of the clinical effects of doubling the duration of standing, using standing frames, in young children who are unable to walk, who have cerebral palsy or developmental delay.
It will determine whether it is feasable to carry out a multi-centred trial.
The study objectives will be to determine:
- presence of adverse events
- recruitment and drop out rate
- compliance with the intervention
- feasibility of the randomisation and minimisation process
- the proportion of the outcome measures taken
- effect size estimate
- required study costs
- effectiveness of blinding procedure
Detailed description
Thirty non-ambulant children with cerebral palsy will be randomised into one of two groups that either (a) maintains the child's current standing frame program- the control group (n=15) (b) doubles the standing time- the intervention group (n=15). Outcome measures will be taken at baseline and at 6 monthly intervals by a blinded assessor.
Research process and flow Families who are willing to participate in the study will be provided with a diary sheet that will allow them to record over a baseline 2 week period how frequently their child stood and in what position. The diary sheet will be available in word or hard copy format. An e mail/ stamped addressed envelope will be provided to return the diary at the end of 2 weeks. Participants will be reminded via text/ phone / e mail (depending on their preferred method of communication) after 1 week if they have not returned their diary sheets.
On receipt of the diary sheets participants will be randomized into an intervention or control group (see below). A therapist will explain the group allocation to the families at their home or their local CDC. The trial will run for 12 months with the outcome measures being taken by an assessor blinded to group allocation. The primary outcome measure (hip migration percentage) will be taken at 0 and 12 months so as to fit in with practice across the South West and not to increase x ray exposure. The secondary outcome measures will be taken at baseline, 6 and 12 months. The final RCT will involve a 3 yr follow-up phase.
Sample Size We aim to recruit 15 people per group. An audit of CDC records suggests that there are between 5-6 eligible participants over a 12 month recruitment period. With 8 main recruitment centres this would result in 40-48 potential participants and a required recruitment rate of 75-63%. An on-going study looking at walking in children with older children with CP at Plymouth University suggests that this recruitment rate is feasible. Determining the actual recruitment rate in this particular patient population and the feasibility of using multiple centres across one region is one objective of the pilot study.
Randomisation
Thirty children with Cerebral Palsy (age 1-12 yrs; GMFCS III-V) will be recruited from South West based services. Participants will be randomly allocated to the intervention or control using a web-based system. A minimisation algorithm will be used to ensure balance between the groups on the basis of the following:
- Age (<6 yrs Vs >6 yrs)
- Functional ability (GMFCS=III or IVs GMFCS =V)
- Baseline standing time (<30 mins Vs >30 mins)
Intervention All participants will already be performing a standing regime as prescribed by their treating therapist. The study design and group allocation will be explained by the research assistant (RA1) either at the local CDC or at the participants' home. The control group will continue their usual standing-frame based regime. The intervention group will double their daily standing-frame time.
In both groups a guidance sheet will be provided about how to progress their standing time for the duration of the trial by 10%/month up to a maximum of 1 hr/day in the control group and 2 hr/day in the intervention group. Following PPI advice the guidance will be personalised to include photos of how to set their child up in their own standing frame and the correct position of supportive straps / correct posture to adopt.
The research assistant will visit both groups at the start of the trial and every 3 months. At each visit they will (a) check the position the child adopts in the standing frame (b) check footwear and splints for use and fit (c) check the progression of treatment (d) check and record any changes to their additional care routine by the treating therapist. Feedback about problems in footwear / splinting will be passed onto the child's treating therapist.
Outcome Measures The primary outcome measure will be taken at baseline (0 months) and at 12 months. This fits in with routine practice cross all centres in the South West although some centres take additional x-rays at 6 months. All other measures will be taken at 0, 6 and 12 months. Outcomes will be measured by an assessor blinded to the group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: controlNormal standing time |
| Doubling standing time | Experimental | Behavioral: Doubling standing timeDoubled standing time calculated by doubling baseline standing time |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical diagnosis of cerebral palsy or developmental delay
- Aged between 1-12 years at the beginning of the study
- Signs UMN involvement with spasticity or hypertonia in at least one limb
- Gross motor function classification III-V
- undertaking a standing programme of at least 1.5hours per week for at least a month
Key exclusion criteria (3 listed)
- Soft tissue release that would require imobilization which would prevent standing within 6 months from the onset of the trial
- Bony surgery Soft that would require imobilization which would prevent standing within 12 months from the onset of the trial
- a fracture that would prevent standing
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 |
|---|---|---|
| Doubling standing timeDoubling standing time using child's previously prescribed standing frame with a progression of 10% increase in time/month up to 2 hrs/day maximum | Behavioural | Doubling standing time |
| controlContinue with usual standing time with a progression of 10% increase in time/month up to 1 hr/day maximum | Behavioural | Control |
Primary outcome
Hip migration Percentage
Time frame: baseline and 12 months
In line with planned hip screening, not additional x rays.
8 secondary outcomes
Standing time
Time frame: weekly over 12 months
Muscle length
Time frame: 0, 6 months and 12 months
Rectus femoris circumference using ultrasound
Time frame: 0, 6, 12 months
Muscle tone hip flexors hamstrings and ankle plantarflexors Tardieu test
Time frame: 0, 6, 12 months
Muscle tone of gastrocnemius using the myotonometer
Time frame: 0, 6, 12 months
Paediatric pain profile
Time frame: 0, 6 12 months
Gross motor function measure
Time frame: 0, 6, 12 months
CP CHILD questionnaire
Time frame: 0, 6, 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 23 Nov 2018.
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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.
Jonathan Marsden, Phd principal investigator
University of Plymouth
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doubling standing time in people with Cerebral Palsy and Developmental Delay, run by Rachel Rapson at 4 sites 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 5 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: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Hip migration Percentage (time frame: baseline and 12 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 23 Nov 2018.