BurnsNCT06386549
Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial
A study testing tele-rehabilitation in people with Burns and Tele-rehabilitation, run by LIAO Peng at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Burns, Tele-rehabilitation, Scar
- What is being tested?
- tele-rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hongkong Poly Uiniversity
Hong Kong
Fu Jinfeng, +8613987695500, fujinfeng@etyy.cn
About this study
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?
Read the 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.
- Conditions
- Burns, Tele-rehabilitation, Scar, Children
- Being tested
- tele-rehabilitation
- Keywords
- tele-rehabilitation, parental stress, scar management, quality of life
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-rehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: tele-rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
Secondary outcomes (1)
psychological stress of caregvers
The Perceived Stress Scale (PSS) is the world's most widely used instrument to measure perceived stress, 14 items，its Chinese version is widely used and has good reliability and validity. Each item in the PSS questionnaire is rated on a five-point Likert scale, ranging from 0 (never) to 4 (very often). Participants are asked to indicate the frequency with which they have experienced each event over the past month.The total score on the PSS can range from 0 to 56. Higher scores indicate a higher level of perceived stress.
Measured: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start14 Nov 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LIAO Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LIAO Peng, The Hong Kong Polytechnic University
- Investigators
- Wang Shumei, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386549
- Sponsor's protocol ID
- HSEARS20220424001
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06386549
- Acronym / sponsor ID
- HSEARS20220424001
- Conditions
- Burns, Tele-rehabilitation, Scar, Children
- Keywords
- tele-rehabilitation, parental stress, scar management, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- LIAO PengUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tele-rehabilitation | Experimental | Behavioral: tele-rehabilitationexperimental 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. |
| routine post-discharge rehabilitation | Active comparator | Behavioral: tele-rehabilitationThe 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tele-rehabilitationUsing 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 | Behavioural | routine post-discharge rehabilitation, tele-rehabilitation |
Primary outcome
The scars of children with burns
Time frame: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
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).
The quality and outcomes of care for burn children
Time frame: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
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.
1 secondary outcome
psychological stress of caregvers
Time frame: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Shumei study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-rehabilitation in people with Burns and Tele-rehabilitation, run by LIAO Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liao Peng (+8613888142871, 19098405g@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The scars of children with burns (time frame: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.