Clinical Effectiveness of Increased Standing Time in Non-ambulant Children With Cerebral Palsy:a Pilot Study
Condition: Cerebral Palsy; Developmental Delay
MeSH terms: Cerebral Palsy
Study type: Interventional

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.

      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:

        1. presence of adverse events

        2. recruitment and drop out rate

        3. compliance with the intervention

        4. feasibility of the randomisation and minimisation process

        5. the proportion of the outcome measures taken

        6. effect size estimate

        7. required study costs

        8. 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.
    

Intervention name(s): Doubling standing time; control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; Continue with usual standing time with a progression of 10% increase in time/month up to 1 hr/day maximum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment