Clinical trial NCT06386549: Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial
Official title: Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Tele-rehabilitation
Scar
Children
Keywords: tele-rehabilitation
parental stress
scar management
quality of life
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are:

* Is tele-rehabilitation better for improving the quality and outcomes of care for burn children?
* Is tele-rehabilitation more effective in improving scar management in children with burns injuries?
* Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries?

Detailed description: In this study, experimental group received a 12-week tele-rehabilitation program, which included face-to-face access to silicone pads, pressure garments, splint and other tools necessary for burn recovery. The tele-rehabilitation program was used for intervention and regular follow-up.

The control group also received a 12-week follow-up, but only on the basis of face-to-face access to silicone pads, pressure garments, splint and other tools necessary for burn recovery.

Researchers will compare whether the trial group has better the quality and outcomes of care and scarring for children and parents who perceived stress.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are based on the recommendations of the American Burn Association.
* Child suffered from burn injury 3-6 years old and had survived the burn event.
* The burn severity quantified by the total body surface area（TBSA）burned is equal or more than 1%.
* TBSA burned is the estimated proportion of the body with second or third degree burns.
* Burns involving neck, trunk，limbs and face.
* Only Chinese parents will be recruited.

Exclusion Criteria:

* 1.Insufficient parental Chinese language proficiency required to complete questionnaires.
* Parents cannot use social software (such as WeChat, QQ, etc.) for video, picture, and text communication after discharge.
* The main caregiver is someone other than the parents.
* Children did not live at home with their parents, such as hospitalization, boarding school, etc.
* Children who are receiving rehabilitation treatment.
* Children who have other severe disease, like cerebral palsy.

Primary outcomes:
measure: The scars of children with burns
timeFrame: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
measure: The quality and outcomes of care for burn children
timeFrame: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
Secondary outcomes:
measure: psychological stress of caregvers
timeFrame: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hongkong Poly Uiniversity
Study officials:
name: Wang Shumei
role: STUDY_CHAIR
References: