Improving comfort and mobility for children with special needs
| ISRCTN | ISRCTN81120790 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81120790 |
- Submission date
- 09/10/2025
- Registration date
- 28/10/2025
- Last edited
- 13/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Different studies consider general rehabilitation for immobile individuals as a part of a 24-hour postural management programme. Little attention has been given to the importance of a sleep system in improving postural care. This study aims to highlight the importance of a sleep system in maximising functional ability and minimising the progression of any musculoskeletal deformity. It will include any neurological diagnosis from a variety of ages to guide therapists in best practice toward postural care.
Who can participate?
Children aged between 2 -17 who have a neurological condition and developed musculoskeletal deformities due to wrong positioning for long period of time.
What does the study involve?
Applying postural management care during bedtime to reduce body asymmetry, increase comfort, and improve the quality of the client’s and caregiver's life. Education, guidance, and support will be given to families and caregivers throughout the research period to promote the success of the intervention. Assessments will be conducted in a Physical Medicine and Rehabilitation Hospital, and the intervention will be applied at home.
What are the possible benefits and risks of participating?
The study aims to prove that postural management care will help in reducing body asymmetry and improving the quality of clients’ and caregivers' lives. No harm will reach the child from applying the intervention; it is a totally safe procedure.
Where is the study run from?
Physical Medicine and Rehabilitation Hospital, Kuwait.
When is the study starting and how long is it expected to run for?
September 2024 to May 2026. The study will start enrolling in October 2025 for 4 months and may extend to 6 months.
Who is funding the study?
Kuwait University, Kuwait.
Who is the main contact?
Bashayer Alkandery, bashayer.alkandery@ku.edu.kw
Contact information
Public, Scientific, Principal investigator
Kuwait University, Aljabria
Kuwait
46300
Kuwait
| Phone | +96594082410 |
|---|---|
| bashayer.alkandery@ku.edu.kw |
Study information
| Study design | Single centre experimental design (within-subjects repeated measure design) interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not applicable |
| Scientific title | Postural management care for children with neurological disorder |
| Study objectives | • Assess the Effectiveness of Sleep Positioning Systems: Evaluate whether sleep positioning systems can reduce body asymmetry for individuals with neurological disorders. • Examine Impact on Quality of Life: Investigate how the use of sleep positioning systems affects the quality of life for both the client and their caregiver. • Address Gaps in Existing Research: Highlight the limited evidence available on the benefits of sleep positioning systems across various neurological conditions, emphasizing the need for further research beyond cerebral palsy. • Contribute to Healthcare Knowledge: Provide valuable insights for healthcare professionals regarding the importance of postural care in managing neurological disorders. |
| Ethics approval(s) |
1. Approved 04/05/2025, Health Sciences Center Ethical Committee for the Use of Humans in Research (College of Medcine, Kuwait University, P.O. box 24923 Safat, Kuwait city, 13110, Kuwait; +965 24636203; esther.samuel@ku.edu.kw), ref: VDR / EC - 2025, 92 2. Approved 20/08/2025, Ministry of Health (Kuwait, Kuwait city, 13001, Kuwait; +9651810005; ccmhr@moh.gov.kw), ref: 428 |
| Health condition(s) or problem(s) studied | Implement postural care during sleep for children with neurological disorders who have developed musculoskeletal deformities |
| Intervention | Participants who meet the inclusion criteria will be randomly assigned using a random number generator to one of three groups: 1. Sleep System Group (Intervention Group) (N=5): Participants in this group will receive specialized sleep system equipment designed to improve posture and sleep quality during bedtime for 6 months. 2. Traditional Treatment Group (Comparison Group)(N=5): Participants in this group will receive traditional treatment, alternating clients’ positions during bedtime for 6 months. 3. Control Group (No Treatment)(N=5): Participants in this group will not receive any form of sleep intervention or treatment during the study period. They will continue with their usual routines without additional support. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sleep system equipment |
| Primary outcome measure | The effectiveness of the sleep positioning system in reducing body asymmetry measured using Goldsmith Indices of Body Symmetry at the 4 to 6-month period |
| Secondary outcome measures | Client and caregiver quality of life (QoL) will be measured using a subjective measure at the 4 to 6-month period |
| Overall study start date | 15/09/2024 |
| Completion date | 20/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target number of participants | 15 |
| Key inclusion criteria | 1. 2 to 17 years old 2. Postural deformity |
| Key exclusion criteria | 1. Recent orthopedic corrective surgery with less than 6 months 2. Any condition that contraindicates postural adjustments |
| Date of first enrolment | 08/10/2025 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- Kuwait
Study participating centre
Kuwait city
13001
Kuwait
Sponsor information
University/education
Aljabria
Kuwait city
46300
Kuwait
| Website | https://www.ku.edu.kw/ |
|---|---|
"ROR" |
https://ror.org/021e5j056 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- KU
- Location
- Kuwait
Results and Publications
| Intention to publish date | 05/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
09/10/2025: Study's existence confirmed by the Health Sciences Center Ethical Committee for the Use of Humans in Research, College of Medicine, Kuwait University, Kuwait.
