BurnsNCT05212441
ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS
A study testing Light emitting diode therapy (LED therapy), Patient/family education program (Home program) and Positioning & Splinting in people with Burns and Hand Burn, run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Burns, Hand Burn, Hand Grasp
- What is being tested?
- Light emitting diode therapy (LED therapy), Patient/family education program (Home program) and Positioning & Splinting
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2022to 10 Jul 2022
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12611
About this study
Official title: ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS: A Randomized Controlled Trial
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.
- Conditions
- Burns, Hand Burn, Hand Grasp, Hand Injuries
- Being tested
- Light emitting diode therapy (LED therapy), Patient/family education program (Home program), Positioning & Splinting, Therapeutic Exercises
- Medical subject headings
- Burns, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light emitting diode therapy (LED therapy)Device
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.
Patient/family education program (Home program)Behavioural
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
Positioning & SplintingProcedure or surgery
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.
Therapeutic ExercisesOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (LED group) | Experimental | 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. Receives: Device: Light emitting diode therapy (LED therapy); Behavioral: Patient/family education program (Home program); Procedure: Positioning & Splinting; Other: Therapeutic Exercises |
| Group B (Control group) | Active comparator | This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment. Receives: Behavioral: Patient/family education program (Home program); Procedure: Positioning & Splinting; Other: Therapeutic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 6 weeks posttreatment
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.
Measured: baseline and 6 weeks posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start25 Feb 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion10 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Ali Hassan ElMeligie, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212441
- Sponsor's protocol ID
- LEDHB2122
- Status last verified
- May 2022
- First submitted
- 15 Jan 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05212441
- Acronym / sponsor ID
- LEDHB2122
- Conditions
- Burns, Hand Burn, Hand Grasp, Hand Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 10 Jul 2022 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (LED group) | Experimental | Device: Light emitting diode therapy (LED therapy), Behavioral: Patient/family education program (Home program), Procedure: Positioning & Splinting, Other: Therapeutic ExercisesThis 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) | Active comparator | Behavioral: Patient/family education program (Home program), Procedure: Positioning & Splinting, Other: Therapeutic ExercisesThis group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light emitting diode therapy (LED therapy)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. | Device | Group A (LED group) |
| Patient/family education program (Home program)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 | Behavioural | Group A (LED group), Group B (Control group) |
| Positioning & SplintingThe 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. | Procedure or surgery | Group A (LED group), Group B (Control group) |
| Therapeutic Exercises1. Passive ROM (PROM). 2. 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. 3. Stretching exercises: A low-load (low-intensity), long-duration stretch 4. Strengthening exercises: done in static mode initially and progress to dynamic strengthening using elastic bands. | Other | Group A (LED group), Group B (Control group) |
Primary outcome
Changes in Total active ROM from baseline to 6 weeks posttreatment
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light emitting diode therapy (LED therapy), Patient/family education program (Home program) and Positioning & Splinting in people with Burns and Hand Burn, run by October 6 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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?
Results are not available in the source record.
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?
Changes in Total active ROM from baseline to 6 weeks posttreatment (time frame: baseline and 6 weeks posttreatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2022.