NCT02141802

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

4 years

First QC Date

May 15, 2014

Last Update Submit

November 20, 2018

Conditions

Cerebral PalsyDevelopmental Delay

Outcome Measures

Primary Outcomes (1)

  • Hip migration Percentage

    In line with planned hip screening, not additional x rays.

    baseline and 12 months

Secondary Outcomes (8)

  • Standing time

    weekly over 12 months

  • Muscle length

    0, 6 months and 12 months

  • Rectus femoris circumference using ultrasound

    0, 6, 12 months

  • Muscle tone hip flexors hamstrings and ankle plantarflexors Tardieu test

    0, 6, 12 months

  • Muscle tone of gastrocnemius using the myotonometer

    0, 6, 12 months

  • +3 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Normal standing time

Behavioral: control

Doubling standing time

EXPERIMENTAL

Doubled standing time calculated by doubling baseline standing time

Behavioral: Doubling standing time

Interventions

Doubling standing timeBEHAVIORAL

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

Doubling standing time
controlBEHAVIORAL

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

Control

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Royal Cornwall Hspitals Trust

Truro, Cornwall, United Kingdom

Location

Honeylands Specialist Child Assessment Centre

Exeter, EX4 8AD, United Kingdom

Location

Child Development centre

Plymouth Devon, PL2 2PQ, United Kingdom

Location

John Parkes Unit Newton Road

Torbay, United Kingdom

Location

MeSH Terms

Conditions

Cerebral PalsyLearning Disabilities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jonathan Marsden, Phd

    University of Plymouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 19, 2014

Study Start

May 1, 2014

Primary Completion

April 30, 2018

Study Completion

October 1, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

GB(4)