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

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

      • Cairo, Egypt, 11241
        • Shorook Physical Therapy Centers

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
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
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.

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.

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

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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