Rebound for Respiratory in School Aged Children and Young People With Neurodisability

NCT05495412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-08-10

No results posted yet for this study

Summary

Background:

Respiratory illness is the most common reason to attend primary and hospital care in children with neurodisability, accruing significant healthcare costs. Moreover, it remains the primary cause of death in this population. Exercise plays an important role in the prevention and management of respiratory illness in children with neurodisability. Rebound therapy is a popular form of therapeutic exercise using trampolines to facilitate movement. It is highly accessible for children with complex neurodisabilities and has been shown to improve muscle tone, balance, sitting posture, behaviour and quality of life. Additional chest health benefits have been observed in other populations, but has yet to be established in children with neurodisability.

Aim:

This clinical study seeks to explore the impact of community-based rebound therapy on chest health outcomes in school-aged children and young people with complex neurodisability and respiratory issues.

Method:

A single case study ABA design, inviting 4-6 children with neurodisability and respiratory issues to participate. The study will comprise of:

Phase A: 6-week observational baseline measures alongside usual care Phase B: 6-week of rebound therapy, delivered twice weekly alongside usual care Phase A: 6-week observational follow up measures alongside usual care.

Measurements:

1. Chest health parameters, measured using respiratory rate, cough frequency, time taken to complete chest care, hospital days, emergency days and primary care consultation days
2. Caregiver-reported chest health, measured using the Respiratory Questionnaire for Children with Neurological Impairment questionnaire.
3. Caregiver reported quality of life, measured using the CPCHILD Questionnaire and an optional exit interview at week 18 of the study
4. Posture will be measured using the Chailey Levels of Ability Scale.
5. Adverse Events, measured through safety monitoring of new symptoms, worsening symptoms, hospital days, emergency department days and primary consultation days.
6. Adherence, measured through % attendance to 12 rebound sessions.

Data Analysis:

For each single case study, serial data will be subjected to within-phase (A) analysis of stability criterion and across phase (AB) analysis. Single outcome measure data will be plotted alongside serial data findings, providing visual analysis and interpretation of trends. The exit interview will provide textual data that will be subject to thematic analysis methods.

Anticipated Results:

Results will provide early proof of concept data informing the short term effects of exercise-based rebound therapy intervention on chest health, posture and quality of life for children with complex neurodisabilities.

A composite of passive respiratory clinical measurements and participant/caregiver-reported outcomes will be proposed, implementing a combination of serial and single measurements to inform feasibility of future hypothesis testing research.

The close monitoring of adverse events and adherence will inform safety of intervention prescribed and feasibility of delivering intervention to children with complex neurodisabilities and respiratory impairment.

Conditions

  • Neurologic Disorder
  • Respiratory Tract Infections

Interventions

OTHER

Rebound therapy

Exercise therapy delivered twice weekly for 6 weeks, during Phase B of an ABA single case study design.

Sponsors & Collaborators

  • UCL Great Ormond Street Institute of Child Health

    collaborator OTHER
  • Jon Marsden

    lead OTHER

Principal Investigators

  • Jonathan Marsden, PhD · University of Plymouth

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2022-09-30
Completion
2022-09-30

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 NCT05495412 on ClinicalTrials.gov