Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial

NCT06386549 | Recruiting DMC

• 1 other identifier: HSEARS20220424001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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?

Conditions

Burns; Tele-rehabilitation; Scar; Children

Keywords

tele-rehabilitation; parental stress; scar management; quality of life

Outcome Measures

Primary Outcomes (2)

• The scars of children with burns

  Ultrasound assessment of scar thickness, The DermaLab Combo assessment of scar Transepidermal Water Loss (TEWL), pigmentation, hydration and elasticity. The normal skin thickness is about 0.07-1.2mm, while the thickness of hypertrophic scars increases with the severity. The DermaLab Combo® (Cortex Technologies, Denmark) is a commercially available skin testing device. It is a high-specification device based on proven technologies. It is an easy to use and commercially available device, making it a viable option for scar assessment in both clinical and research settings. The worse the scar condition, the greater the Transepidermal Water Loss (TEWL), the darker the pigmentation (the larger the value), the smaller the hydration, and the smaller the elasticity (the larger the value).

  baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)

• The quality and outcomes of care for burn children

  The health outcomes burn questionnaire (HOBQ) for infants and children 6 years of age and younger is developed by American Burn Association/Shriners Hospitals for Children. The HOBQ has a total of 55 items, calculated on a hundred-point scale, the higher the score, the better. Consists of 10 subscale, and each item is also converted into a percentage system. For the same score, the higher the better. There are 5 items for play, 4 items for language, 7 items for fine motor skills, 7 items for gross motor skills, 9 items for behavior, 5 items for family, 7 items for pain/itching, 3 items for appearance, 5 items for satisfaction, and 3 items for concern/worry. The number of items per scale ranges from two to nine. All subscales relate to the past month,except the subscale 'satisfaction'. The questionnaire has been translated into Chinese, and the reliability and validity of its Chinese version have also been confirmed.

  baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)

Secondary Outcomes (1)

• psychological stress of caregvers

  baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)

Study Arms (2)

tele-rehabilitation

EXPERIMENTAL

experimental group received an 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.

Behavioral: tele-rehabilitation

routine post-discharge rehabilitation

ACTIVE COMPARATOR

The control group also received an 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.

Behavioral: tele-rehabilitation

Interventions

tele-rehabilitation BEHAVIORAL

Using the social networking tool WeChat, families of children with burns are educated and trained through texts, photos, voice messages, and live videos, twice a week for a total of 12 weeks

routine post-discharge rehabilitation; tele-rehabilitation

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LIAO Peng: lead

Study Sites (1)

Hongkong Poly Uiniversity

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Burns; Cicatrix

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Wang Shumei

  STUDY CHAIR

Central Study Contacts

Liao Peng

CONTACT

+8613888142871; 19098405g@connect.polyu.hk

Le Rongnan

CONTACT

+8618313875676; 1046919494@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 26, 2024
• Study Start: November 14, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)