Standing frames for children with Cerebral Palsy_v1

  • Research type

    Research Study

  • Full title

    Standing frames as part of postural management for children with spastcity. What is the acceptability of a trial to determine the efficacy of standing frames?

  • IRAS ID

    182263

  • Contact name

    Jill Kisler

  • Contact email

    j.e.kisler@newcastle.ac.uk

  • Sponsor organisation

    Newcastle Upon Tyne Hospitals NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    BH137926, BH - university ref.; 82916961, ISRCTN

  • Duration of Study in the UK

    1 years, 9 months, 31 days

  • Research summary

    1:400 UK children has cerebral palsy (CP). Children with CP may be unable to walk and have associated learning or communication difficulties. CP is caused by damage to the brain, before birth or in the first year of life. Although the brain damage does not change, effects on the body such as pain, limb and joint deformity do. Physiotherapy treatment may include using a Standing Frame but there is much variation in UK practice.
    There is little evidence to support the proposed benefits of standing frames which include improvement in limb movement, bone strength, bladder and bowel control, breathing, participation in activities; and prevention of hip dislocation. Frames also have disadvantages: they use space, take time and may be uncomfortable and expensive.

    To assess the usefulness of standing frames, a trial is needed where children are assigned by chance to using a frame or not. However, not using a frame may not be acceptable to some children, parents and healthcare providers who think that they are helpful. This study aims to prepare for a feasible and acceptable trial to assess the effectiveness of standing frames for children with CP by:
    Step 1: Survey 1 to understand current practice in the UK. How are frames used? How long do children stand in them? Are there difficulties with using frames?
    Step 2: Discussions using focus groups with parents and healthcare staff and interviews with children. What do users think about frames? Why are they useful? Are trials needed? What are the pros and cons of frame use? Would users be prepared to stop using a frame, or be allocated by chance to different frame use in a trial?
    Step 3: Survey 2 will summarise findings from the first two steps and seek opinion on potential trial designs.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    15/EM/0495

  • Date of REC Opinion

    9 Dec 2015

  • REC opinion

    Further Information Favourable Opinion