- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497103
Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn (HandBurn)
July 29, 2020 updated by: Maged Basha, Qassim University
The Jebsen-Taylor Hand Function Test and Canadian Occupational Performance Measure (COPM) were considered as primary outcome measurements.
Secondary outcomes included total active range of motion (ROM) of the digits, hand grip strength and pinch strengths (tip, palmer and lateral pinch).
All measurement was conducted at two occasions: at the baseline and after intervention.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The included participant were children with a deep partial thickness or a full thickness burn induced by either a scaled or a flame thermal burn with involvement of more than 50% of the hand and wrist, total body surface area (TBSA) less than 30% , age ranged from 7 to 14 years, recent discharge of inpatient acute care, spontaneous healing (within 34 weeks) or grafting with split thickness or full-thickness skin grafts (at least before 2 weeks).
Children were excluded from this study if they had infection, juvenile arthritis, fracture, tendon injuries, muscle injury, degenerative joint diseases, peripheral nerve diseases, Pre - established psychologically and physically disorders (extreme aphasia, cognitive and developmental deficits that can influence the rehabilitation).
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 11241
- Shorook Physical Therapy Centers
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children with deep partial thickness or a full thickness burn
- burn induced by either a scaled or a flame thermal burn
- involvement of more than 50% of the hand and wrist
- total body surface area (TBSA) less than 30%
- age ranged from 7 to 14 years
- recent discharge of inpatient acute care
- spontaneous healing (within 34 weeks)
- grafting with split thickness or full-thickness skin grafts (at least before 2 weeks).
Exclusion Criteria:
- children with infection
- juvenile arthritis
- fracture
- tendon injuries
- muscle injury
- degenerative joint diseases
- peripheral nerve diseases
- Pre - established psychologically and physically disorders
- extreme aphasia
- cognitive and developmental deficits that can influence the rehabilitation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: control
The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.
|
The traditional therapy included immersing the hand in paraffin for 10 min; soft massaging with a moisturizing gel for 5 min; passive mobilization of the wrist, MP, PIP, and DIP joints; active/passive ROM and stretching exercises; strengthening exercises (done in static mode initially and progressed in the second month to dynamic strengthening using elastic bands); desensitizing sensory stimulation of hypertrophic scars, occupational therapy.
|
EXPERIMENTAL: task oriented training
Task-oriented training TOT group was conducted with an average of 50-min sessions three times a week for 8 weeks.
Baseline Canadian Occupational Performance Measure COPM results were used to generate individualized intervention goals for each participant.
|
The traditional therapy included immersing the hand in paraffin for 10 min; soft massaging with a moisturizing gel for 5 min; passive mobilization of the wrist, MP, PIP, and DIP joints; active/passive ROM and stretching exercises; strengthening exercises (done in static mode initially and progressed in the second month to dynamic strengthening using elastic bands); desensitizing sensory stimulation of hypertrophic scars, occupational therapy.
The traditional plus the target activities involved training with the materials (clothes, spoons, pencils, buttons, rope, etc) needed for the activity as well as Velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.
|
EXPERIMENTAL: Xbox kinect
Xbox training group was conducted with an average of 50-min sessions three times a week for 8 weeks.
Baseline Canadian Occupational Performance Measure COPM results were used to generate individualized intervention goals for each participant.
|
The traditional therapy included immersing the hand in paraffin for 10 min; soft massaging with a moisturizing gel for 5 min; passive mobilization of the wrist, MP, PIP, and DIP joints; active/passive ROM and stretching exercises; strengthening exercises (done in static mode initially and progressed in the second month to dynamic strengthening using elastic bands); desensitizing sensory stimulation of hypertrophic scars, occupational therapy.
The traditional plus Xbox Kinect games were related to five target activities determined according to the person-centered analysis results were chosen for each patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Jebsen-Taylor Hand Function Test
Time Frame: baseline
|
is an objective and standard method designed to assess the hand's functional abilities
|
baseline
|
Jebsen-Taylor Hand Function Test
Time Frame: immediately after the intervention
|
is an objective and standard method designed to assess the hand's functional abilities
|
immediately after the intervention
|
Duruoz Hand Index
Time Frame: baseline
|
is a self-reported questionnaire developed to assess hand ability in the kitchen, during dressing, while performing personal hygiene and office tasks, and other general items
|
baseline
|
Duruoz Hand Index
Time Frame: immediately after the intervention
|
is a self-reported questionnaire developed to assess hand ability in the kitchen, during dressing, while performing personal hygiene and office tasks, and other general items
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immediately after the intervention
|
Canadian Occupational Performance Measure
Time Frame: baseline
|
is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.
|
baseline
|
Canadian Occupational Performance Measure
Time Frame: immediately after the intervention
|
is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.
|
immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total active range of motion (ROM) of the digits
Time Frame: baseline
|
The total active ROM was measured by a hand-held steel finger goniometer
|
baseline
|
total active range of motion (ROM) of the digits
Time Frame: immediately after the intervention
|
The total active ROM was measured by a hand-held steel finger goniometer
|
immediately after the intervention
|
hand grip strength
Time Frame: baseline
|
Grip strength was assessed using a Jamar hydraulic dynamometer
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baseline
|
hand grip strength
Time Frame: immediately after the intervention
|
Grip strength was assessed using a Jamar hydraulic dynamometer
|
immediately after the intervention
|
pinch strength
Time Frame: baseline
|
pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer
|
baseline
|
pinch strength
Time Frame: immediately after the intervention
|
pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Maged Basha, PhD, Qassim University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Parry I, Painting L, Bagley A, Kawada J, Molitor F, Sen S, Greenhalgh DG, Palmieri TL. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up. J Burn Care Res. 2015 Sep-Oct;36(5):534-44. doi: 10.1097/BCR.0000000000000165.
- Voon K, Silberstein I, Eranki A, Phillips M, Wood FM, Edgar DW. Xbox Kinect based rehabilitation as a feasible adjunct for minor upper limb burns rehabilitation: A pilot RCT. Burns. 2016 Dec;42(8):1797-1804. doi: 10.1016/j.burns.2016.06.007. Epub 2016 Jul 9.
- Kamel FAH, Basha MA. Effects of Virtual Reality and Task-Oriented Training on Hand Function and Activity Performance in Pediatric Hand Burns: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Jun;102(6):1059-1066. doi: 10.1016/j.apmr.2021.01.087. Epub 2021 Feb 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2018
Primary Completion (ACTUAL)
September 20, 2019
Study Completion (ACTUAL)
September 20, 2019
Study Registration Dates
First Submitted
July 24, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (ACTUAL)
August 4, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 4, 2020
Last Update Submitted That Met QC Criteria
July 29, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2694PT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after de-identification (text, tables,and figures)
IPD Sharing Time Frame
Immediately following publication.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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