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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04497103
Other study ID # 2694PT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date September 20, 2019

Study information

Verified date July 2020
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). All measurement was conducted at two occasions: at the baseline and after intervention.


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).


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date September 20, 2019
Est. primary completion date September 20, 2019
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
control
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 kinect
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 training
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.

Locations

Country Name City State
Egypt Shorook Physical Therapy Centers Cairo

Sponsors (2)

Lead Sponsor Collaborator
Qassim University Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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 — View 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 Ju — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Jebsen-Taylor Hand Function Test is an objective and standard method designed to assess the hand's functional abilities baseline
Primary Jebsen-Taylor Hand Function Test is an objective and standard method designed to assess the hand's functional abilities immediately after the intervention
Primary 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
Primary 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
Primary Canadian Occupational Performance Measure is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time. baseline
Primary 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 total active range of motion (ROM) of the digits The total active ROM was measured by a hand-held steel finger goniometer baseline
Secondary total active range of motion (ROM) of the digits The total active ROM was measured by a hand-held steel finger goniometer immediately after the intervention
Secondary hand grip strength Grip strength was assessed using a Jamar hydraulic dynamometer baseline
Secondary hand grip strength Grip strength was assessed using a Jamar hydraulic dynamometer immediately after the intervention
Secondary pinch strength pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer baseline
Secondary pinch strength pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer immediately after the intervention
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