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

NCT05495412 | Unknown

• 2 other identifiers: 2698NIHR301008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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

Conditions

Neurologic Disorder; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Change in caregiver-reported respiratory symptoms between week 0, 6, 12 and week 18

  Self/proxy reported respiratory symptoms in the last month, using the Respiratory Questionnaire For Children with Neurological Impairment

  Proposed Measurement point: week 0, 6, 12, and 18.

Secondary Outcomes (8)

• Change in Clinical Respiratory Observations

  Proposed Measurement points: serial weekly measurements from week 0-18.

• Change in Chailey Levels of Ability

  Proposed Measurement points: week 0, 6, 12, 18

• Change in Caregiver Priorities & Child Health Index of Life with Disabilities questionnaire

  Proposed Measurement points: week 0, 6, 12, 18

• Change in self-reported general health

  Proposed Measurement points: serial weekly measurements from week 0-18.

• Change in self-reported change in postural management care plan

  Proposed Measurement points: serial weekly measurements from week 0-18.

Study Arms (1)

Rebound therapy

OTHER

Exercise therapy which uses a full sized trampoline to provide opportunities for movement, therapeutic exercise and recreation for children and young people.

Other: Rebound therapy

Interventions

Rebound therapy OTHER

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

Rebound therapy

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: \>4 years up to \<16years
• Access to a caregiver in a position of main custody, capable of giving consent on the participant's behalf
• Access to a caregiver in a position of main custody who is able to consent to also participate in the study
• Accesses full time education
• Clinical diagnosis of neurodisability
• Physical impairment Gross Motor Function Classification Scale level 3-5 defined as: (Level 3): Walks with aids. Uses wheelchair for long distances; (Level 4): Self mobility with powered mobility; (Level 5): Severely limited, unable to lift head and trunk or use powered mobility due to other comorbidities like vision impairment.
• Swallow impairment Eating Drinking Ability Classification Scale Level 3-5, defined as (Level 3): Eats and drinks with some limitations to safety; maybe limitations to efficiency; (Level 4): Eats and drinks with significant limitations to safety; (Level 5): Unable to eat or drink safely - tube feeding may be considered to provide nutrition
• Symptoms of respiratory impairment, experienced at least once a week, defined as one or more of the following: (1) Noisy breathing (wheezy, gurgling, rattily etc.); (2) Weak/poor cough; (3) Difficulty clearing secretions AND a history of a chest infection in the past 3 years requiring medication.
• Risk assessment of safe access to educational setting
• Risk assessment of contraindications and care factors for rebound therapy

You may not qualify if:

• Children diagnosed with a progressive neurological presentation, including muscular dystrophies.
• Children with a confirmed absolute contraindication that will determine the participant unsuitable to participate in rebound therapy. These include: (1)Cranio-vertebral Instability (including Atlanto-Axial Instability \& Atlanto-Occipital Instability); (2) Detatching retina (s) or repaired retina (s); (3) Pregnancy; (4) Brittle bones; (5) Dwarfism; (6) Spinal rodding.

Sponsors & Collaborators

• Jon Marsden: lead
• UCL Great Ormond Street Institute of Child Health: collaborator

Study Sites (3)

Bidwell Brook School

Dartington, Devon, TQ9 6JU, United Kingdom

ACTIVE NOT RECRUITING

John Parkes Unit, Torbay Hospital, Torbay and South Devon NHS Foundation Trust

Torquay, Devon, TQ2 7BA, United Kingdom

RECRUITING

Mayfield School

Torquay, TQ2 8NH, United Kingdom

RECRUITING

Related Publications (4)

• Morris C, Janssens A, Tomlinson R, Williams J, Logan S. Towards a definition of neurodisability: a Delphi survey. Dev Med Child Neurol. 2013 Dec;55(12):1103-8. doi: 10.1111/dmcn.12218. Epub 2013 Aug 5.

  PMID: 23909744 BACKGROUND

• Gibson N, Blackmore AM, Chang AB, Cooper MS, Jaffe A, Kong WR, Langdon K, Moshovis L, Pavleski K, Wilson AC. Prevention and management of respiratory disease in young people with cerebral palsy: consensus statement. Dev Med Child Neurol. 2021 Feb;63(2):172-182. doi: 10.1111/dmcn.14640. Epub 2020 Aug 9.

  PMID: 32803795 BACKGROUND

• Winfield NR, Barker NJ, Turner ER, Quin GL. Non-pharmaceutical management of respiratory morbidity in children with severe global developmental delay. Cochrane Database Syst Rev. 2014 Oct 19;2014(10):CD010382. doi: 10.1002/14651858.CD010382.pub2.

  PMID: 25326792 BACKGROUND

• Bradley JM, Moran FM, Elborn JS. Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: an overview of five Cochrane systematic reviews. Respir Med. 2006 Feb;100(2):191-201. doi: 10.1016/j.rmed.2005.11.028.

  PMID: 16412951 BACKGROUND

Related Links

• The National Confidential Enquiry into Patient Outcome and Death. Each and Every Need. 2018. London
• Bruce, S. and Stanley, D. Standards of Practice for Physiotherapists Working with adults with a learning disability. 2020
• Roberts, D. Bounce Benefits, Physiotherapy Frontline. 2006. 12(3); 12-14.

MeSH Terms

Conditions

Nervous System Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Jonathan Marsden, PhD

  University of Plymouth

  STUDY CHAIR

Central Study Contacts

Jonathan Marsden, PhD

CONTACT

+441752587590; jonathan.marsden@plymouth.ac.uk

Rachel Rapson, MSc

CONTACT

+441752587486; rachel.rapson@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Rehabilitation

Model Details: single case study

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: August 10, 2022
• Study Start: March 25, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

GB (3)