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ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS

Primary Purpose

Burns, Hand Burn, Hand Grasp

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Light emitting diode therapy (LED therapy)
Patient/family education program (Home program)
Positioning & Splinting
Therapeutic Exercises
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subject selection will be according to the following criteria:

  • Burn caused by thermal injury (flame or scald) with involvement of the wrist and hand and other parts of the body not including shoulder and elbow.
  • Age range between 20-35 years.
  • Male gender.
  • Subacute Partial-thickness burn " From 3rd day of burn".
  • Recent discharge of in patient acute care, spontaneous healing.
  • All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

  • Cardiac diseases.
  • Perception of persistent respiratory problem related to a previous inhalation injury
  • Signs of burn infection (i.e., unclear fluid oozing from the wound, increased pain, expanded redness and swelling)
  • Exposed tendons.
  • Nerve, muscle injury.
  • Scar contracture of hand.
  • Cognitive disorders.
  • Presence of fractures.
  • Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
  • Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.

Sites / Locations

  • October 6 University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (LED group)

Group B (Control group)

Arm Description

This group includes 30 burned patients who will receive LED therapy in addition to their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.

This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.

Outcomes

Primary Outcome Measures

Changes in Total active ROM from baseline to 6 weeks posttreatment
Total active ROM is the sum of the active metacarpophalangeal (MP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) arc of motion in degrees of an individual digit. The measurement will be performed via a hand-held finger goniometer
Changes in hand grip strength from baseline to 6 weeks posttreatment
A calibrated hydraulic JAMAR (Model: 5030J1, Sammons Preston Rolyan, Chicago, USA), analogue hand-grip dynamometer will be used to measure grip strength. The device provides 1 kg increments on the measurement dial which faces the assessor as mentioned by Clifford et al., 2013.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2022
Last Updated
May 6, 2022
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05212441
Brief Title
ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS
Official Title
ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 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
This study will be done to evaluate effect of applying LED before hand exercise on hand grip strength. Sixty male patients with subacute partial thickness burn of hand will be randomly allocated into two equal groups of 30 patients. The following equipment and tools will be used Measurement equipments: For total active motion of fingers (TAM): Goniometer. For hand grip strength: Hand grip dynamometer. Therapeutic equipment: Light emitting diode therapy (LED) device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Hand Burn, Hand Grasp, Hand Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (LED group)
Arm Type
Experimental
Arm Description
This group includes 30 burned patients who will receive LED therapy in addition to their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
Arm Title
Group B (Control group)
Arm Type
Active Comparator
Arm Description
This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
Intervention Type
Device
Intervention Name(s)
Light emitting diode therapy (LED therapy)
Intervention Description
The patient's forearm is positioned on table with palm facuing upward during the therapy. For LEDT, the center of the light spot located at approximately 50% of landmark line from the medial epicondyle to the styloid process of the ulna, which is the center belly of flexor digitorum superficialis. The subject's forearm maintained in the rest state without moving during the therapy. LED is performed before exercise.
Intervention Type
Behavioral
Intervention Name(s)
Patient/family education program (Home program)
Intervention Description
Patients and their families will instructed to learn the anti contracture positioning/splinting, scar massage and exercises program, application of the custom garments and inserts, and functional training to perform them on their own at home. Written and illustrative instructions and reciprocal demonstration sessions will be provided to the children and their families to ensure successful acquisition and delivery of rehabilitation skills at home program. The therapist will be reported about compliance with the home program every couple of days
Intervention Type
Procedure
Intervention Name(s)
Positioning & Splinting
Intervention Description
The wrist joint is splinted at 30 hyperextension, the MCP joint in 90 of flexion, the IP joints in extension, and the thumb in abduction. The webs of fingers kept in abduction. The hands are elevated above the level of the heart to minimize post-burn edema. Splinting: Splints are tailored to help to maintain the functional or anti-contracture position of the injured body parts.The intervals for monitoring vary from once every hour to once every 4-6 hours, depending on types of splints and skin conditions. It is described as 10 hours on and two hours off. When the splint is taken off, active and/or passive ROM should be carried out.
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercises
Intervention Description
Passive ROM (PROM). Active ROM (AROM) & Active-assistive ROM (AAROM): The exercise will focus on extending the wrist to 45 degrees, flexing the MCP joints to 90 degrees and keeping the IP joints in full extension, while maintaining a thumb web space. The exercises will performed in the following sequences; (1) MCP joints flexion and extension with the wrist in neutral or slight extension and the IP joints in neutral position. (2) IP joints flexion to only 30-40 degrees with the wrist stabilized in the neutral or slight extension, while the MCP joints held in full extension, (3) thumb and fingers abduction and adduction, and (4) thumb opposition (tip of the thumb to tip of the small finger). Each exercise was performed for 8-10 repetition, daily, for 6 days/week. Stretching exercises: A low-load (low-intensity), long-duration stretch Strengthening exercises: done in static mode initially and progress to dynamic strengthening using elastic bands.
Primary Outcome Measure Information:
Title
Changes in Total active ROM from baseline to 6 weeks posttreatment
Description
Total active ROM is the sum of the active metacarpophalangeal (MP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) arc of motion in degrees of an individual digit. The measurement will be performed via a hand-held finger goniometer
Time Frame
baseline and 6 weeks posttreatment
Title
Changes in hand grip strength from baseline to 6 weeks posttreatment
Description
A calibrated hydraulic JAMAR (Model: 5030J1, Sammons Preston Rolyan, Chicago, USA), analogue hand-grip dynamometer will be used to measure grip strength. The device provides 1 kg increments on the measurement dial which faces the assessor as mentioned by Clifford et al., 2013.
Time Frame
baseline and 6 weeks posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject selection will be according to the following criteria: Burn caused by thermal injury (flame or scald) with involvement of the wrist and hand and other parts of the body not including shoulder and elbow. Age range between 20-35 years. Male gender. Subacute Partial-thickness burn " From 3rd day of burn". Recent discharge of in patient acute care, spontaneous healing. All patients enrolled to the study will have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: Cardiac diseases. Perception of persistent respiratory problem related to a previous inhalation injury Signs of burn infection (i.e., unclear fluid oozing from the wound, increased pain, expanded redness and swelling) Exposed tendons. Nerve, muscle injury. Scar contracture of hand. Cognitive disorders. Presence of fractures. Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases. Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.
Facility Information:
Facility Name
October 6 University Hospital
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
12611
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS

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