Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree BurnsROM-SDBNCT07883863
Impact of Range of Motion Exercises on Pain and Functional Ability
A study testing Range of Motion exercises in people with Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns, run by Al-Azhar University.
Trial summary
The goal of this quasi-experimental study is to evaluate the effect of range of motion (ROM) exercises on pain and functional ability among adult patients of both genders with second-degree burn injuries affecting the upper and/or lower extremities. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
- What is being tested?
- Range of Motion exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Apr 2027
- Phase
- Interventional
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients (18 to 60 years old) from both genders recently diagnosed with second degree burn injury.
- The burn in upper limb and/or lower limb injury.
Who cannot join
- Neurological problems such as a history of joint problems (rheumatoid arthritis, osteoarthritis, and any joint abnormality), serious fracture, amputation and severe infection.
- Contraindications to ROM such as chronic obstructive pulmonary disease (COPD) and deep venous thrombosis (DVT).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fatin A Ahmed, Bachelor Degree of Nursing contact
About this study
Official title: Range of Motion Exercises and Their Effects on Pain and Functional Ability Among Patients With Second Degree Burn Injury
The goal of this quasi-experimental study is to evaluate the effect of range of motion (ROM) exercises on pain and functional ability among adult patients of both genders with second-degree burn injuries affecting the upper and/or lower extremities.
The main questions addressed by the study are:
Read more
Do range of motion exercises reduce pain levels among patients with second-degree burn injuries? Do range of motion exercises improve the functional ability of burned upper and/or lower extremities among patients with second-degree burn injuries?
A comparison between the study group receiving range of motion exercises and the control group receiving routine care will be conducted to evaluate the effects of range of motion exercises on pain levels and functional ability.
Study participants will undergo the following procedures:
Assessment of pain levels before implementing range of motion exercises. Assessment of the functional ability of burned upper and/or lower extremities before implementing range of motion exercises.
Implementation of range of motion exercises for the study group according to the study protocol.
Provision of routine care to the control group. Post-intervention assessment of pain levels and functional ability to evaluate changes following the intervention.
Read the detailed description
Burn injuries represent a significant global public health concern because of their potential to cause physical impairment, prolonged hospitalization, psychological distress, and reduced quality of life. The consequences of burn injuries extend beyond the initial tissue damage and may include persistent pain, restricted mobility, muscle weakness, joint stiffness, scar formation, and limitations in daily activities. These complications may affect functional independence and increase the need for rehabilitation and supportive care.
Second-degree burns, also known as partial-thickness burns, involve the epidermis and part of the dermis. These burns are classified into superficial partial-thickness and deep partial-thickness burns according to the depth of tissue involvement. Superficial partial-thickness burns commonly present with blisters, a moist wound surface, and significant pain. Healing generally occurs within approximately two to three weeks, depending on the extent of the injury and the healing process. Deep partial-thickness burns extend further into the dermis and may require a longer healing period, with an increased risk of scarring and functional impairment.
Pain is one of the most common and distressing symptoms experienced by patients with burn injuries. Burn-related pain may arise from the initial injury, wound care procedures, tissue healing, and restricted movement. Pain intensity varies according to the depth, extent, and location of the burn, as well as the stage of recovery. Persistent pain may limit movement, reduce participation in rehabilitation activities, and interfere with the performance of activities of daily living.
Burn injuries affecting the upper and lower extremities may lead to restricted joint mobility, muscle weakness, scar contractures, and impaired functional performance. Such limitations can interfere with essential daily activities, including dressing, bathing, eating, grooming, walking, and personal hygiene. Functional impairment may be particularly significant when burns involve the hands, arms, legs, or joints, where adequate mobility is essential for independent movement and self-care.
Range of motion (ROM) exercises are therapeutic movements designed to maintain or improve joint mobility, preserve flexibility, and reduce movement restrictions. These exercises are generally classified into three types: active range of motion (AROM), passive range of motion (PROM), and active-assisted range of motion (AAROM). AROM exercises involve independent joint movement performed by the patient. PROM exercises involve joint movement performed by a healthcare professional without active participation from the patient. AAROM exercises involve active movement with assistance from a healthcare professional when additional support is required to complete the movement.
ROM exercises may play an important role in the rehabilitation of patients with burn injuries by maintaining joint mobility, minimizing stiffness, and supporting the recovery of functional movement. Appropriate exercises may facilitate the gradual restoration of movement in affected extremities and support the performance of daily activities. The selection and implementation of exercises depend on the patient's clinical condition, the location and extent of the burn, and any relevant medical contraindications.
The evaluation of pain and functional ability is essential for determining the potential benefits of ROM exercises among patients with second-degree burn injuries. Assessment of pain intensity and the functional performance of affected upper and lower extremities before and after the intervention can help identify changes associated with the exercise program. Comparison of outcomes between the study group receiving ROM exercises and the control group receiving routine care will provide information regarding the effectiveness of ROM exercises in reducing pain and improving functional ability among patients with second-degree burn injuries.
Despite the importance of rehabilitation in burn care, further evaluation of the effects of range of motion (ROM) exercises on pain and functional ability among patients with second-degree burn injuries is warranted. Assessing changes in pain intensity and the functional ability of affected upper and lower extremities may provide valuable evidence regarding the role of ROM exercises in improving rehabilitation outcomes. Therefore, the present study aims to evaluate the effects of ROM exercises on pain and functional ability among patients with second-degree burn injuries through a comparison between a study group receiving ROM exercises and a control group receiving routine care.
- Conditions
- Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
- Being tested
- Range of Motion exercises
- Keywords
- Range of motion exercises , Pain , Functional ability , Burn injury
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Range of Motion exercisesOther
Also called study group intervention
A structured, individualized ROM exercise program will be implemented for study group with second-degree burn injuries affecting the upper or lower extremities. The program will be conducted three times daily for three consecutive weeks. Each targeted joint movement will be repeated 10 times and maintained for 30 seconds within the available pain-free range of motion. Exercises will target the shoulders, elbows, and wrists of the upper extremities and the hips, knees, and ankles of the lower extremities, according to the location of the burn injury. The exercises will be demonstrated and supervised by the researcher during hospitalization and performed according to the study protocol
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in this group will receive routine hospital nursing care and standard medical management for second-degree burn injuries according to institutional protocols. Prescribed analgesic medications will be administered according to the attending physicians' orders. Pain intensity and functional ability will be assessed at baseline and at the end of the three-week study period using the Numeric Pain Rating Scale (NPRS), Upper Extremity Functional Index (UEFI), and Lower Extremity Functional Scale (LEFS), according to the location of the burn injury. |
| Study group (Range of Motion Exercises Group) | Experimental | Study Group:
Patients this will receive routine hospital care, including pharmacological therapy, hydrotherapy, and wound dressing, in addition to Range of Motion (ROM) exercises. The researcher will demonstrate the ROM exercises to patients in the burn inpatient and outpatient units. The exercises will be performed three times daily, with each movement repeated 10 times and held for 30 seconds, according to the full range of motion of the major joints of the upper and lower extremities, including the wrists, elbows, shoulders, thighs, knees, and ankles. Pain level and functional ability of the burned limb will be assessed before and after the intervention using the Numeric Pain Rating Scale, Upper Extremity Functional index, and Lower Extremity Functional Scale, respectively. The final assessment will be conducted after three weeks. Receives: Other: Range of Motion exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Structured Interview Questionnaire
It will be divided into two parts and written in the Arabic language. Part 1: Patient's demographic characteristics
It aims to assess patient' age, gender, marital status, degree of education …. etc.
Part 2: Medical health profile It aims to assess information on the patient's present history, past history. It will include cause of burn, degree of burn, percent of burn, first aid, skin graft, limb affected, date of admission and date of discharge.
Measured: Baseline assessment before the intervention
Change in Pain Intensity
Pain Numeric Rating Scale It will be used to assess the patient's level of pain through asked the patient to make four pain ratings from 0 to 10 score, corresponding to current, no pain, mild, moderate and severe pain experienced.
Scoring system
- 0 (no pain)
- 3 (mild pain)
- 4 - 6 (moderate pain)
- 7- 10 (severe pain)
Measured: Baseline assessment before the intervention and follow-up assessment at the end of 3 weeks.
Change in Functional Ability of the Affected upper Extremities
Upper Extremity Functional Index (UEFI) It will be used to assess upper extremities functional abilities of patients with burn injury in performing activities of daily living. The scale lists 20 activities, and the patient gives a score to each based on the difficulty they have completing that activity. The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.
This scale has 5-point rating scale, ranging from 0 to 4. 0 indicates extreme difficulty or unable to perform activity while 4 indicates no difficulty. A lower score indicates that the person is reporting increased difficulty with the daily activities as a result of their limb condition.
- (0 - 9) extreme extremity functional limitation.
- (10 - 31) severe extremity functional limitation.
- (32 - 52) moderate extremity functional limitation.
- (53 - 79) mild extremity functional limitation.
- (80) no extremity functional limitation.
Measured: Baseline and 3 weeks after the intervention
Change in Functional Ability of the Affected lower Extremities
Lower Extremity Functional Scale (LEFS) It will used to assess the functional limitation of a patient with lower extremities burn injury. The scale lists 20 activities, and the patient gives a score to each based on the difficulty they have completing that activity.
This scale has 5-point rating scale, ranging from 0 to 4. 0 indicates extreme difficulty or unable to perform activity while 4 indicates no difficulty. A lower score indicates that the person is reporting increased difficulty with the daily activities as a result of their limb condition.
- (0 - 9) extreme extremity functional limitation.
- (10 - 31) severe extremity functional limitation.
- (32 - 52) moderate extremity functional limitation.
- (53 - 79) mild extremity functional limitation.
- (80) no extremity functional limitation.
Measured: Baseline and 3 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The principal investigator will be responsible for participant recruitment and group allocation through individual face-to-face interviews, with an average of four patient evaluations per week. A purposive sample of 80 eligible patients will be recruited and divided into two groups: a study group (n = 40) and a control group (n = 40), without random assignment. Baseline Assessment Before the implementation of the intervention, baseline assessments will be conducted for participants in both groups. Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). Functional ability of the affected upper and/or lower extremities will be assessed using the Upper Extremity Functional Index (UEFI) and the Lower Extremity Functional Scale (LEFS), according to the location of the burn injury. Intervention Protocol: Range of Motion Exercises Analgesic Management: Participants in both groups will receive analgesic medications prescribed by the attending physicians according to hospita
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatin Ali Soliman Ahmed, Al-Azhar University
- Investigators
- Manal Hassan, PhD, Study director, Professor of Medical Surgical Nursing, Faculty of Nursing, Ain Shams University, Cairo, Egypt.Abeer W Aziz, PhD, Study director, Professor of Medical Surgical Nursing, Faculty of Nursing, Ain Shams University, Cairo, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883863
- Sponsor's protocol ID
- ROM-SDB 26.03.1150
- Acronym
- ROM-SDB
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No