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

Not Applicable

• Conditions: Burns; Hand Grasp; Hand Burn; Hand Injuries
• Interventions: Device: Light emitting diode therapy (LED therapy); Behavioral: Patient/family education program (Home program); Procedure: Positioning & Splinting; Other: Therapeutic Exercises

• Registration Number: NCT05212441
• Lead Sponsor: October 6 University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Study Start: 2022-02-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-10
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (LED group)	Therapeutic Exercises	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.
Group A (LED group)	Patient/family education program (Home program)	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.
Group B (Control group)	Therapeutic Exercises	This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
Group A (LED group)	Positioning & Splinting	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.
Group B (Control group)	Patient/family education program (Home program)	This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
Group A (LED group)	Light emitting diode therapy (LED therapy)	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.
Group B (Control group)	Positioning & Splinting	This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.

Primary Outcome Measures

Name	Time	Method
Changes in Total active ROM from baseline to 6 weeks posttreatment	baseline and 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	baseline and 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.

Trial Locations

Locations (1)

October 6 University Hospital; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt