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Clinical Effectiveness of Increased Standing Time in Non-ambulant Children With Cerebral Palsy:a Pilot Study

NCT02141802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-11-23

No results posted yet for this study

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

Conditions

  • Cerebral Palsy
  • Developmental Delay

Interventions

BEHAVIORAL

Doubling standing time

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

BEHAVIORAL

control

Continue with usual standing time with a progression of 10% increase in time/month up to 1 hr/day maximum

Sponsors & Collaborators

  • University of Plymouth

    collaborator OTHER

  • Rachel Rapson

    lead OTHER

Principal Investigators

  • Jonathan Marsden, Phd · University of Plymouth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-01
Primary Completion
2018-04-30
Completion
2018-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141802 on ClinicalTrials.gov