BurnsXboxBurnNCT04350034
Xbox Kinect Promote Physical Fitness and Lean Mass in Severely Burned Children
A study testing Xbox training in people with Burns, run by Qassim University.
Trial summary
The outcome measures included quadriceps muscle strength as measured using an isokinetic dynamometer, LBM is measured by DEXA and cardiopulmonary fitness was assessed by measuring VO2 peak during a standardized treadmill exercise test using the modified Bruce protocol. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Burns
- What is being tested?
- Xbox training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2016to 20 Sep 2019
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- total body surface area (TBSA) of 40-60%.
- being ambulatory without an assistant.
Who cannot join
- metabolic disorders.neuropathy.
- visual or vestibular disorders.
- amputation.
- participation in another study.
- history of epilepsy.
- loss of balance.
- lower or upper limb deformity.
About this study
Official title: Xbox Kinect™ to Promote Physical Fitness and Lean Mass in Severely Burned Children: A Randomized Controlled Trial
The outcome measures included quadriceps muscle strength as measured using an isokinetic dynamometer, LBM is measured by DEXA and cardiopulmonary fitness was assessed by measuring VO2 peak during a standardized treadmill exercise test using the modified Bruce protocol. All outcome measures were evaluated immediately after discharge as baseline and after 12 weeks of intervention.
Read the detailed description
Forty healed pediatric burn patients (24 boys and 16 girls), aged 10 - 15 years, were enrolled from the outpatient clinic in the faculty of physical therapy, Cairo university, Egypt. The inclusion criteria were: total body surface area (TBSA) of 40-60%, being ambulatory without an assistant. The exclusion criteria included metabolic disorders, neuropathy, visual or vestibular disorders, amputation, participation in another study, any adverse medication reactions, history of epilepsy, loss of balance, and lower or upper limb deformity. All patients received similar standard medical care and treatment from the time of admission until the time of discharge.
Total burn surface area was assessed by the "modified Lund and Browder charts" method during excisional surgery immediately following hospital admittance. Informed written consent was obtained from each patient's guardian prior to enrollment.
All procedures were approved by the ethical committee of the faculty of physical therapy, Cairo university, Giza, Egypt. After consent was obtained, patients were randomly assigned to standard of care group (SOC) or Xbox training group (Xbox).
The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program (N=20). In contrast, the SOC group participated in the routine physiotherapy program (N=20).
A normal activity of daily living (ADL), diet and patient's lifestyle were maintained for all participants as much as possible.
- Conditions
- Burns
- Being tested
- Xbox training, Control group
- Keywords
- lean body mass, VO2 Peak, muscle strength, Enjoyment, Severely burned children, Xbox Kinect
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xbox trainingOther
Also called interactive video games
patients in this group received routine physical therapy protocol plus Xbox training.
Before the intervention started, the Xbox group was given a 45 min introductory session on how to use the xbox adventure games and its tools. All sessions were led by a single experienced physiotherapist (different to the physiotherapist who performed the assessments tests) in order to provide instruction on how to perform each exercise.
Control groupOther
Also called Standard of care
routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.
| Study group | Role | What they receive |
|---|---|---|
| Xbox training group | Experimental | The study group received Xbox training plus routine physical therapy protocol treatment. The dose of Xbox training was 50 min, three times a week for 12 weeks, using the Xbox gaming system (Xbox 360 Kinect console; Microsoft Inc., Redmond, Washington, USA). Receives: Other: Xbox training; Other: Control group |
| Control group | Placebo comparator | patients participated in a routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 peak
determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.
Measured: pre-intervention (1 month after burn injury)
VO2 peak
determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.
Measured: after 12 weeks of treatment
Secondary outcomes (2)
Isokinetic testing Muscle strength
assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).
Measured: pre-intervention (1 month after burn injury)
Isokinetic testing Muscle strength
assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).
Measured: after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 Jun 2016
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Factorial
- Model description
- The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program. The control group participated in the routine physiotherapy program. In the study group received Xbox training, the dose of Xbox training was 50 min, three times a week for 12 weeks, using the Xbox gaming system. The games were anticipated onto a 45-inch Samsung television. The playing area was 16 \* 12 m. The content of Xbox training consisted of practicing five Xbox games (Rally Ball, Reflex Ridge, River Rush, 2000 Leaks and parkour). Children practiced each game for 10 min, bringing about every session enduring 50 min.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350034
- Sponsor's protocol ID
- 2656PT
- Acronym
- XboxBurn
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Herndon DN, Rodriguez NA, Diaz EC, Hegde S, Jennings K, Mlcak RP, Suri JS, Lee JO, Williams FN, Meyer W, Suman OE, Barrow RE, Jeschke MG, Finnerty CC. Long-term propranolol use in severely burned pediatric patients: a randomized controlled study. Ann Surg. 2012 Sep;256(3):402-11. doi: 10.1097/SLA.0b013e318265427e.
PubMed 22895351Hettiaratchy S, Papini R. Initial management of a major burn: II--assessment and resuscitation. BMJ. 2004 Jul 10;329(7457):101-3. doi: 10.1136/bmj.329.7457.101. No abstract available.
PubMed 15242917Przkora R, Herndon DN, Suman OE. The effects of oxandrolone and exercise on muscle mass and function in children with severe burns. Pediatrics. 2007 Jan;119(1):e109-16. doi: 10.1542/peds.2006-1548. Epub 2006 Nov 27.
PubMed 17130281Basha MA, Aboelnour NH, Aly SM, Kamel FAH. Impact of Kinect-based virtual reality training on physical fitness and quality of life in severely burned children: A monocentric randomized controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101471. doi: 10.1016/j.rehab.2020.101471. Epub 2021 Nov 23.
PubMed 33316436
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xbox Kinect™ to Promote Physical Fitness and Lean Mass in Severely Burned Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04350034
- Acronym / sponsor ID
- XboxBurn / 2656PT
- Conditions
- Burns
- Keywords
- lean body mass, VO2 Peak, muscle strength, Enjoyment, Severely burned children, Xbox Kinect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 16 Apr 2020 (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 outcome measures included quadriceps muscle strength as measured using an isokinetic dynamometer, LBM is measured by DEXA and cardiopulmonary fitness was assessed by measuring VO2 peak during a standardized treadmill exercise test using the modified Bruce protocol. All outcome measures were evaluated immediately after discharge as baseline and after 12 weeks of intervention.
Detailed description
Forty healed pediatric burn patients (24 boys and 16 girls), aged 10 - 15 years, were enrolled from the outpatient clinic in the faculty of physical therapy, Cairo university, Egypt. The inclusion criteria were: total body surface area (TBSA) of 40-60%, being ambulatory without an assistant. The exclusion criteria included metabolic disorders, neuropathy, visual or vestibular disorders, amputation, participation in another study, any adverse medication reactions, history of epilepsy, loss of balance, and lower or upper limb deformity. All patients received similar standard medical care and treatment from the time of admission until the time of discharge.
Total burn surface area was assessed by the "modified Lund and Browder charts" method during excisional surgery immediately following hospital admittance. Informed written consent was obtained from each patient's guardian prior to enrollment.
All procedures were approved by the ethical committee of the faculty of physical therapy, Cairo university, Giza, Egypt. After consent was obtained, patients were randomly assigned to standard of care group (SOC) or Xbox training group (Xbox).
The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program (N=20). In contrast, the SOC group participated in the routine physiotherapy program (N=20).
A normal activity of daily living (ADL), diet and patient's lifestyle were maintained for all participants as much as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program. The control group participated in the routine physiotherapy program. In the study group received Xbox training, the dose of Xbox training was 50 min, three times a week for 12 weeks, using the Xbox gaming system. The games were anticipated onto a 45-inch Samsung television. The playing area was 16 * 12 m. The content of Xbox training consisted of practicing five Xbox games (Rally Ball, Reflex Ridge, River Rush, 2000 Leaks and parkour). Children practiced each game for 10 min, bringing about every session enduring 50 min.
| Arm | Type | Receives |
|---|---|---|
| Xbox training group | Experimental | Other: Xbox training, Other: Control groupThe study group received Xbox training plus routine physical therapy protocol treatment. The dose of Xbox training was 50 min, three times a week for 12 weeks, using the Xbox gaming system (Xbox 360 Kinect console; Microsoft Inc., Redmond, Washington, USA). |
| Control group | Placebo comparator | Other: Control grouppatients participated in a routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- total body surface area (TBSA) of 40-60%.
- being ambulatory without an assistant.
Key exclusion criteria (7 listed)
- metabolic disorders.neuropathy.
- visual or vestibular disorders.
- amputation.
- participation in another study.
- history of epilepsy.
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 |
|---|---|---|
| Xbox trainingAlso: interactive video gamespatients in this group received routine physical therapy protocol plus Xbox training. Before the intervention started, the Xbox group was given a 45 min introductory session on how to use the xbox adventure games and its tools. All sessions were led by a single experienced physiotherapist (different to the physiotherapist who performed the assessments tests) in order to provide instruction on how to perform each exercise. | Other | Xbox training group |
| Control groupAlso: Standard of careroutine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training. | Other | Control group, Xbox training group |
Primary outcome
VO2 peak
Time frame: pre-intervention (1 month after burn injury)
determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.
VO2 peak
Time frame: after 12 weeks of treatment
determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.
2 secondary outcomes
Isokinetic testing Muscle strength
Time frame: pre-intervention (1 month after burn injury)
Isokinetic testing Muscle strength
Time frame: after 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Background: PubMed 22895351Herndon DN, Rodriguez NA, Diaz EC, Hegde S, Jennings K, Mlcak RP, Suri JS, Lee JO, Williams FN, Meyer W, Suman OE, Barrow RE, Jeschke MG, Finnerty CC. Long-term propranolol use in severely burned pediatric patients: a randomized controlled study. Ann Surg. 2012 Sep;256(3):402-11. doi: 10.1097/SLA.0b013e318265427e.
- Background: PubMed 15242917Hettiaratchy S, Papini R. Initial management of a major burn: II--assessment and resuscitation. BMJ. 2004 Jul 10;329(7457):101-3. doi: 10.1136/bmj.329.7457.101. No abstract available.
- Background: PubMed 17130281Przkora R, Herndon DN, Suman OE. The effects of oxandrolone and exercise on muscle mass and function in children with severe burns. Pediatrics. 2007 Jan;119(1):e109-16. doi: 10.1542/peds.2006-1548. Epub 2006 Nov 27.
- Derived from this study: PubMed 33316436Basha MA, Aboelnour NH, Aly SM, Kamel FAH. Impact of Kinect-based virtual reality training on physical fitness and quality of life in severely burned children: A monocentric randomized controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101471. doi: 10.1016/j.rehab.2020.101471. Epub 2021 Nov 23.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Xbox training in people with Burns, run by Qassim University.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 peak (time frame: pre-intervention (1 month after burn injury)). 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?
On the ClinicalTrials.gov record for NCT04350034, which also lists 4 linked publications.
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 16 Apr 2020.