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BurnsHandBurnNCT04497103

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

A study testing Xbox kinect and task oriented training in people with Burns and Hand Burn, run by Qassim University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 7 to 14 years
Conditions the study is for
Burns, Hand Burn
What is being tested?
Xbox kinect and task oriented training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteEgypt
Study dates
1 May 2018to 20 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • children with infection
  • juvenile arthritis
  • fracture
  • tendon injuries
  • muscle injury
  • degenerative joint diseases
Show all 10Show fewer
  • peripheral nerve diseases
  • Pre - established psychologically and physically disorders
  • extreme aphasia
  • cognitive and developmental deficits that can influence the rehabilitation

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Shorook Physical Therapy Centers

    Cairo, 11241

Other trials in Egypt

About this study

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.

Read the 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).

Conditions
Burns, Hand Burn
Being tested
control, Xbox kinect, task oriented training
Keywords
children burns, Hand Function, Grip strength, pinch strength, Jebsen-Taylor Hand Function Test, Duruoz Hand Index, Canadian Occupational Performance Measure
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 kinectOther

    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.

  • task oriented trainingOther

    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.

Study groups in NCT04497103
Study groupRoleWhat they receive
controlActive comparatorThe traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.
Receives: Other: control
task oriented trainingExperimentalTask-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.
Receives: Other: control; Other: task oriented training
Xbox kinectExperimentalXbox 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.
Receives: Other: control; Other: Xbox kinect

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Jebsen-Taylor Hand Function Test

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

    Measured: baseline

  2. Jebsen-Taylor Hand Function Test

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

    Measured: immediately after the intervention

  3. 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

    Measured: baseline

  4. 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

    Measured: immediately after the intervention

  5. Canadian Occupational Performance Measure

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

    Measured: baseline

  6. Canadian Occupational Performance Measure

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

    Measured: immediately after the intervention

Secondary outcomes (6)

  1. total active range of motion (ROM) of the digits

    The total active ROM was measured by a hand-held steel finger goniometer

    Measured: baseline

  2. total active range of motion (ROM) of the digits

    The total active ROM was measured by a hand-held steel finger goniometer

    Measured: immediately after the intervention

  3. hand grip strength

    Grip strength was assessed using a Jamar hydraulic dynamometer

    Measured: baseline

  4. hand grip strength

    Grip strength was assessed using a Jamar hydraulic dynamometer

    Measured: immediately after the intervention

  5. pinch strength

    pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer

    Measured: baseline

  6. pinch strength

    pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start1 May 2018
  3. Primary completion20 Sep 2019
  4. Study completion20 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497103
Sponsor's protocol ID
2694PT
Acronym
HandBurn
Status last verified
Jul 2020
First submitted
24 Jul 2020
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables,and figures)

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.

    PubMed 26335108

  • 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.

    PubMed 27402183

  • 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.

    PubMed 33617863

Questions about this trial

What is this clinical trial studying?

A study testing Xbox kinect and task oriented training in people with Burns and Hand Burn, run by Qassim University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Jebsen-Taylor Hand Function Test (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04497103, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.

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