BurnsNCT07017764
Combined Effect of Core Stability and Theraband Resisted Exercises on Gait Parameters in Lower Limb Burn
A study testing Core stability exercises, Theraband resisted exercises and Traditional physical therapy program in people with Burns, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is designed to evaluate the combined effect of core stability and theraband resisted exercises on gait parameters in lower limb burn. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Burns
- What is being tested?
- Core stability exercises, Theraband resisted exercises and Traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2025to 26 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will suffer from second degree lower limb burn (Partial thickness of thermal injury).
- Total body surface area (TBSA) for the burns will be ranged from 20% to 25% .
- Patients will begin the training program after complete skin closure from (1-2) weeks.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- Patients who had an open wound at or near treatment site.
- Patients who had chemical or electrical burn.
- Neurological and renal disorders.
- Malignant conditions.
- Psychiatric illness, severe behavior or cognitive disorders.
- Use of neurological drugs that influence gait parameters.
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- History of lower extremity injuries with in the last 6 months.
- History of muscular/ neural aliments (myopathy, myositis, peripheral neuropathy, muscular dystrophy).
- Postural abnormality in the upper or lower extremities (such as kyphosis, lordosis, forward head, knee valgus and knee varus).
- Surgery or fracture within a year before the study.
- Insulin-dependent diabetes.
- Joint rheumatoid arthritis.
- Diagnosed cerebrovascular disease or any other disease that interferes with sensory input.
- Lower extremity rotational deformities (increased anteversion, tibial torsion or pes planovalgus).
- Hormonal changes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Noha Mohamed Kamel, PhD contact
Egypt1 site
El Mahalla General Hospital and Burn Center in Mansoura University Hospital
Al Mansurah
Noura Mohamed Fouad Hussein, B.Sc, +20 102 690 2134, nouranew2022@gmail.com
About this study
The purpose of the study is designed to evaluate the combined effect of core stability and theraband resisted exercises on gait parameters in lower limb burn.
Read the detailed description
Impairments such as pain and decreased range of motion (ROM) may develop in patients who have thermal burn on their lower extremities. These impairments may contribute to an individual's functional limitations, including impaired gait. For example, patients with burns on planter aspects of their feet have difficulty with ambulation because of pain. Also, individuals with burns on Achilles tendon area or popliteal space have difficulty with ambulation because of decreased ROM of the ankle and knee, respectively. Burns on the lower extremities may cause changes in step length and deviations in heel-toe gait pattern as the patient tries to avoid bearing down on the affected extremity. Patients with lower extremity burns may walk with decreased stance phase on the affected lower extremity, a decreased swing phase on the unaffected lower extremity, and a wider base of support.
One goal of core stability is to optimize motor control of the lumbo-pelvic region to sustain functional stability in neutral positions and contribute to producing and transmitting energy from the trunk to the limbs.
Core stability aims to provide proximal stability to facilitate distal mobility and power generation, particularly in movements in which the stability of the spine is involved.
Since 1980 and with resounding research and outcomes, the use of the Theraband as an elastic resistance training (ERT) modality has become a common treatment intervention. Improved functional ability, enhanced strength and endurance with higher muscular activation, and reduced injury risks are some of its advantages.
Systematic resistance exercise, results in gait analysis changes in the synergy ratios of different muscle groups, while resistance training using elastic bands increases muscle strength levels and improves explosive strength. Also, evident is the effect of elastic resistance exercise in increasing the range of motion, the flexibility of movement, walking ability (effect on kinematic parameters in gait analysis) and the promotion of various skills of everyday life. Furthermore, the need for this study is developed from the lack of information in the published studies about the effect of core stability and theraband resisted exercises on gait parameters in lower limb burn. So, this study is designed to evaluate the combined effect of core stability and theraband resisted exercises on gait parameters in lower limb burn.
- Conditions
- Burns
- Being tested
- Core stability exercises, Theraband resisted exercises, Traditional physical therapy program
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability exercisesOther
Core stability exercises will be performed for 8 weeks, 3 times per week, 30 minutes per session. The program includes bed, wedge, and Swiss ball exercises. Bed exercises involve bridges, curl-ups, bird dog, and side bridges. Wedge exercises include curl-ups in various arm positions. Ball exercises involve bridges, curl-ups, bird dog, and push-ups. Each position is held for 7 seconds with 10 seconds of rest, repeated 10 times per set, for 2 sets per session with 60 seconds rest between sets.
Theraband resisted exercisesOther
TheraBand resisted exercises will be performed for 8 weeks, 3 times per week, 30 minutes per session. Each session includes a 5-minute warm-up (stretching and joint mobilization), 30 minutes of resistance training for lower limbs (ankle, knee, hip), and a 5-minute cool-down with deep breathing and self-massage. Exercises include ankle flexion/extension, knee flexion/extension, and hip flexion/extension, abduction/adduction using elastic bands. Movements are done alternately on both sides, 10 reps each, 3 sets per session, with 1-2 min rest between sets. Yellow bands are used in weeks 1-4; green bands in weeks 5-8.
Traditional physical therapy programOther
All patients will receive a traditional physical therapy program consisting of ambulation training, stretching exercises for lower limb muscles, and range of motion exercises.
| Study group | Role | What they receive |
|---|---|---|
| Core stability exercises + Theraband resisted exercises + Traditional physical therapy program | Experimental | This group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive core stability and theraband resisted exercises in addition to a traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises. Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Core stability exercises; Other: Theraband resisted exercises; Other: Traditional physical therapy program |
| Core stability exercises + Traditional physical therapy program | Active comparator | This group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive core stability exercises in addition to traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises.
Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Core stability exercises; Other: Traditional physical therapy program |
| Theraband resisted exercises + Traditional physical therapy program | Active comparator | This group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive theraband resisted exercises in addition to traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises. Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Theraband resisted exercises; Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length
Using two-dimentional (2D) videobased gait assessment system, the distance between the ipsilateral and contralateral heel strikes will be measured in meters before and after treatment for all participants in the three groups.
Measured: 8 weeks
Stride length
Using two-dimentional (2D) videobased gait assessment system, the distance between two consecutive heel strikes of the same foot will be measured in meters before and after treatment for all participants in the three groups.
Measured: 8 weeks
Step width
Using two-dimentional (2D) videobased gait assessment system, the distance between the centre lines of the two feet, perpendicular to the plane of walking will be measured in centimeters before and after treatment for all participants in the three groups.
Measured: 8 weeks
Step time
Using two-dimentional (2D) videobased gait assessment system, the time between ipsilateral and contralateral heel strikes will be measured in seconds before and after treatment for all participants in the three groups.
Measured: 8 weeks
Stride time
Using two-dimentional (2D) videobased gait assessment system, the time elapsed between the first contact of two consecutive footsteps of the same foot will be measured in seconds before and after treatment for all participants in the three groups.
Measured: 8 weeks
Cadence
Using two-dimentional (2D) videobased gait assessment system, the number of steps in a minute, [steps/ minute]. It will be measured in seconds before and after treatment for all participants in the three groups.
Measured: 8 weeks
Velocity
Using two-dimentional (2D) videobased gait assessment system, the distance covered by the body in unit time, (meter/minute) = Step length × Cadence. It will be measured in seconds before and after treatment for all participants in the three groups.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start11 Jun 2025 (estimated)
- Primary completion11 Oct 2025 (estimated)
- Study completion26 Oct 2025 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Mohamed Fouad Hussein, Cairo University
- Investigators
- Eman Mohamed Othman, PhD, Study chair, Professor, Cairo universityTarek Ahmed Amer, PhD, Study director, Professor, Cairo universityNoha Mohamed Kamel, PhD, Study director, Lecturer, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017764
- Sponsor's protocol ID
- P.T.REC/012/005543
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Core Stability and Theraband Resisted Exercises on Gait Parameters in Lower Limb Burn
- ClinicalTrials.gov ID
- NCT07017764
- Acronym / sponsor ID
- P.T.REC/012/005543
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (estimated)
- Primary completion
- 11 Oct 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 12 Jun 2025 (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.
The purpose of the study is designed to evaluate the combined effect of core stability and theraband resisted exercises on gait parameters in lower limb burn.
Detailed description
Impairments such as pain and decreased range of motion (ROM) may develop in patients who have thermal burn on their lower extremities. These impairments may contribute to an individual's functional limitations, including impaired gait. For example, patients with burns on planter aspects of their feet have difficulty with ambulation because of pain. Also, individuals with burns on Achilles tendon area or popliteal space have difficulty with ambulation because of decreased ROM of the ankle and knee, respectively. Burns on the lower extremities may cause changes in step length and deviations in heel-toe gait pattern as the patient tries to avoid bearing down on the affected extremity. Patients with lower extremity burns may walk with decreased stance phase on the affected lower extremity, a decreased swing phase on the unaffected lower extremity, and a wider base of support.
One goal of core stability is to optimize motor control of the lumbo-pelvic region to sustain functional stability in neutral positions and contribute to producing and transmitting energy from the trunk to the limbs.
Core stability aims to provide proximal stability to facilitate distal mobility and power generation, particularly in movements in which the stability of the spine is involved.
Since 1980 and with resounding research and outcomes, the use of the Theraband as an elastic resistance training (ERT) modality has become a common treatment intervention. Improved functional ability, enhanced strength and endurance with higher muscular activation, and reduced injury risks are some of its advantages.
Systematic resistance exercise, results in gait analysis changes in the synergy ratios of different muscle groups, while resistance training using elastic bands increases muscle strength levels and improves explosive strength. Also, evident is the effect of elastic resistance exercise in increasing the range of motion, the flexibility of movement, walking ability (effect on kinematic parameters in gait analysis) and the promotion of various skills of everyday life. Furthermore, the need for this study is developed from the lack of information in the published studies about the effect of core stability and theraband resisted exercises on gait parameters in lower limb burn. So, this study is designed to evaluate the combined effect of core stability and theraband resisted exercises on gait parameters in lower limb burn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core stability exercises + Theraband resisted exercises + Traditional physical therapy program | Experimental | Other: Core stability exercises, Other: Theraband resisted exercises, Other: Traditional physical therapy programThis group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive core stability and theraband resisted exercises in addition to a traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
| Core stability exercises + Traditional physical therapy program | Active comparator | Other: Core stability exercises, Other: Traditional physical therapy programThis group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive core stability exercises in addition to traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
| Theraband resisted exercises + Traditional physical therapy program | Active comparator | Other: Theraband resisted exercises, Other: Traditional physical therapy programThis group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive theraband resisted exercises in addition to traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients will suffer from second degree lower limb burn (Partial thickness of thermal injury).
- Total body surface area (TBSA) for the burns will be ranged from 20% to 25% .
- Patients will begin the training program after complete skin closure from (1-2) weeks.
- All patients enrolled to the study will have their informed consent.
Key exclusion criteria (15 listed)
- Patients who had an open wound at or near treatment site.
- Patients who had chemical or electrical burn.
- Neurological and renal disorders.
- Malignant conditions.
- Psychiatric illness, severe behavior or cognitive disorders.
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 |
|---|---|---|
| Core stability exercisesCore stability exercises will be performed for 8 weeks, 3 times per week, 30 minutes per session. The program includes bed, wedge, and Swiss ball exercises. Bed exercises involve bridges, curl-ups, bird dog, and side bridges. Wedge exercises include curl-ups in various arm positions. Ball exercises involve bridges, curl-ups, bird dog, and push-ups. Each position is held for 7 seconds with 10 seconds of rest, repeated 10 times per set, for 2 sets per session with 60 seconds rest between sets. | Other | Core stability exercises + Theraband resisted exercises + Traditional physical therapy program, Core stability exercises + Traditional physical therapy program |
| Theraband resisted exercisesTheraBand resisted exercises will be performed for 8 weeks, 3 times per week, 30 minutes per session. Each session includes a 5-minute warm-up (stretching and joint mobilization), 30 minutes of resistance training for lower limbs (ankle, knee, hip), and a 5-minute cool-down with deep breathing and self-massage. Exercises include ankle flexion/extension, knee flexion/extension, and hip flexion/extension, abduction/adduction using elastic bands. Movements are done alternately on both sides, 10 reps each, 3 sets per session, with 1-2 min rest between sets. Yellow bands are used in weeks 1-4; green bands in weeks 5-8. | Other | Core stability exercises + Theraband resisted exercises + Traditional physical therapy program, Theraband resisted exercises + Traditional physical therapy program |
| Traditional physical therapy programAll patients will receive a traditional physical therapy program consisting of ambulation training, stretching exercises for lower limb muscles, and range of motion exercises. | Other | Core stability exercises + Theraband resisted exercises + Traditional physical therapy program, Core stability exercises + Traditional physical therapy program, Theraband resisted exercises + Traditional physical therapy program |
Primary outcome
Step length
Time frame: 8 weeks
Using two-dimentional (2D) videobased gait assessment system, the distance between the ipsilateral and contralateral heel strikes will be measured in meters before and after treatment for all participants in the three groups.
Stride length
Time frame: 8 weeks
Using two-dimentional (2D) videobased gait assessment system, the distance between two consecutive heel strikes of the same foot will be measured in meters before and after treatment for all participants in the three groups.
Step width
Time frame: 8 weeks
Using two-dimentional (2D) videobased gait assessment system, the distance between the centre lines of the two feet, perpendicular to the plane of walking will be measured in centimeters before and after treatment for all participants in the three groups.
Step time
Time frame: 8 weeks
Using two-dimentional (2D) videobased gait assessment system, the time between ipsilateral and contralateral heel strikes will be measured in seconds before and after treatment for all participants in the three groups.
Stride time
Time frame: 8 weeks
Using two-dimentional (2D) videobased gait assessment system, the time elapsed between the first contact of two consecutive footsteps of the same foot will be measured in seconds before and after treatment for all participants in the three groups.
Cadence
Time frame: 8 weeks
Using two-dimentional (2D) videobased gait assessment system, the number of steps in a minute, [steps/ minute]. It will be measured in seconds before and after treatment for all participants in the three groups.
Velocity
Time frame: 8 weeks
Using two-dimentional (2D) videobased gait assessment system, the distance covered by the body in unit time, (meter/minute) = Step length × Cadence. It will be measured in seconds before and after treatment for all participants in the three groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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.
Noha Mohamed Kamel, PhD contact
Eman Mohamed Othman, PhD study chair
Professor, Cairo university
Tarek Ahmed Amer, PhD study director
Professor, Cairo university
Noha Mohamed Kamel, PhD study director
Lecturer, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability exercises, Theraband resisted exercises and Traditional physical therapy program in people with Burns, run by Cairo 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 4 inclusion and 15 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: opening soon, as of the sponsor's last update on 12 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noura Mohamed Fouad Hussein, B.Sc (+20 102 690 2134, nouranew2022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length (time frame: 8 weeks). The study lists 7 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 12 Jun 2025.