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Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn (HandBurn)

Primary Purpose

Burns, Hand Burn

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
control
Xbox kinect
task oriented training
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring children burns, Hand Function, Grip strength, pinch strength, Jebsen-Taylor Hand Function Test, Duruoz Hand Index, Canadian Occupational Performance Measure

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shorook Physical Therapy Centers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

control

task oriented training

Xbox kinect

Arm Description

The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.

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.

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.

Outcomes

Primary Outcome Measures

Jebsen-Taylor Hand Function Test
is an objective and standard method designed to assess the hand's functional abilities
Jebsen-Taylor Hand Function Test
is an objective and standard method designed to assess the hand's functional abilities
Duruoz Hand Index
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
Duruoz Hand Index
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
Canadian Occupational Performance Measure
is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.
Canadian Occupational Performance Measure
is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.

Secondary Outcome Measures

total active range of motion (ROM) of the digits
The total active ROM was measured by a hand-held steel finger goniometer
total active range of motion (ROM) of the digits
The total active ROM was measured by a hand-held steel finger goniometer
hand grip strength
Grip strength was assessed using a Jamar hydraulic dynamometer
hand grip strength
Grip strength was assessed using a Jamar hydraulic dynamometer
pinch strength
pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer
pinch strength
pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer

Full Information

First Posted
July 24, 2020
Last Updated
July 29, 2020
Sponsor
Qassim University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04497103
Brief Title
Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn
Acronym
HandBurn
Official Title
Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Hand Burn
Keywords
children burns, Hand Function, Grip strength, pinch strength, Jebsen-Taylor Hand Function Test, Duruoz Hand Index, Canadian Occupational Performance Measure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Task-oriented training TOT group and Xbox training group were conducted with an average of 50-min sessions three times a week for 8 weeks. The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.
Arm Title
task oriented training
Arm Type
Experimental
Arm Description
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.
Arm Title
Xbox kinect
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Xbox kinect
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
task oriented training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Jebsen-Taylor Hand Function Test
Description
is an objective and standard method designed to assess the hand's functional abilities
Time Frame
baseline
Title
Jebsen-Taylor Hand Function Test
Description
is an objective and standard method designed to assess the hand's functional abilities
Time Frame
immediately after the intervention
Title
Duruoz Hand Index
Description
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
Time Frame
baseline
Title
Duruoz Hand Index
Description
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
Time Frame
immediately after the intervention
Title
Canadian Occupational Performance Measure
Description
is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.
Time Frame
baseline
Title
Canadian Occupational Performance Measure
Description
is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
total active range of motion (ROM) of the digits
Description
The total active ROM was measured by a hand-held steel finger goniometer
Time Frame
baseline
Title
total active range of motion (ROM) of the digits
Description
The total active ROM was measured by a hand-held steel finger goniometer
Time Frame
immediately after the intervention
Title
hand grip strength
Description
Grip strength was assessed using a Jamar hydraulic dynamometer
Time Frame
baseline
Title
hand grip strength
Description
Grip strength was assessed using a Jamar hydraulic dynamometer
Time Frame
immediately after the intervention
Title
pinch strength
Description
pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer
Time Frame
baseline
Title
pinch strength
Description
pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maged Basha, PhD
Organizational Affiliation
Qassim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shorook Physical Therapy Centers
City
Cairo
ZIP/Postal Code
11241
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
26335108
Citation
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.
Results Reference
result
PubMed Identifier
27402183
Citation
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.
Results Reference
result
PubMed Identifier
33617863
Citation
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.
Results Reference
derived

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Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn

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