NCT04497103

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

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

May 1, 2018

Completed
1.4 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
10 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

July 24, 2020

Last Update Submit

July 29, 2020

Conditions

Keywords

children burnsHand FunctionGrip strengthpinch strengthJebsen-Taylor Hand Function TestDuruoz Hand IndexCanadian Occupational Performance Measure

Outcome Measures

Primary Outcomes (6)

  • Jebsen-Taylor Hand Function Test

    is an objective and standard method designed to assess the hand's functional abilities

    baseline

  • Jebsen-Taylor Hand Function Test

    is an objective and standard method designed to assess the hand's functional abilities

    immediately after the intervention

  • 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

    baseline

  • 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

    immediately after the intervention

  • Canadian Occupational Performance Measure

    is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.

    baseline

  • Canadian Occupational Performance Measure

    is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.

    immediately after the intervention

Secondary Outcomes (6)

  • total active range of motion (ROM) of the digits

    baseline

  • total active range of motion (ROM) of the digits

    immediately after the intervention

  • hand grip strength

    baseline

  • hand grip strength

    immediately after the intervention

  • pinch strength

    baseline

  • +1 more secondary outcomes

Study Arms (3)

control

ACTIVE COMPARATOR

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

Other: control

task oriented training

EXPERIMENTAL

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.

Other: controlOther: task oriented training

Xbox kinect

EXPERIMENTAL

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.

Other: controlOther: Xbox kinect

Interventions

controlOTHER

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.

Xbox kinectcontroltask oriented training

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.

Xbox kinect

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.

task oriented training

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shorook Physical Therapy Centers

Cairo, 11241, Egypt

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Maged Basha, PhD

    Qassim University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.

Study Record Dates

First Submitted

July 24, 2020

First Posted

August 4, 2020

Study Start

May 1, 2018

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after de-identification (text, tables,and figures)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Immediately following 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.

Locations