NCT04350034

Brief 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. All outcome measures were evaluated immediately after discharge as baseline and after 12 weeks of intervention.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

3.3 years

First QC Date

April 9, 2020

Last Update Submit

April 15, 2020

Conditions

Keywords

lean body massVO2 Peakmuscle strengthEnjoymentSeverely burned childrenXbox Kinect

Outcome Measures

Primary Outcomes (2)

  • VO2 peak

    determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.

    pre-intervention (1 month after burn injury)

  • VO2 peak

    determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.

    after 12 weeks of treatment

Secondary Outcomes (2)

  • Isokinetic testing Muscle strength

    pre-intervention (1 month after burn injury)

  • Isokinetic testing Muscle strength

    after 12 weeks of treatment

Study Arms (2)

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).

Other: Xbox trainingOther: 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.

Other: Control group

Interventions

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.

Also known as: interactive video games
Xbox training group

routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.

Also known as: Standard of care
Control groupXbox training group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • total body surface area (TBSA) of 40-60%.
  • being ambulatory without an assistant.

You may not qualify if:

  • metabolic disorders.neuropathy.
  • visual or vestibular disorders.
  • amputation.
  • participation in another study.
  • history of epilepsy.
  • loss of balance.
  • lower or upper limb deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22895351BACKGROUND
  • Hettiaratchy 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.

    PMID: 15242917BACKGROUND
  • Przkora 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.

    PMID: 17130281BACKGROUND
  • Basha 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.

MeSH Terms

Conditions

Burns

Interventions

Control GroupsStandard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 16, 2020

Study Start

June 15, 2016

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
IPD will be available upon reasonable request by email from the main author after revising the requester qualification relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.