BurnsNCT06718829
Effect of Core Stability and Sensorimotor Training Exercises on Postural Stability Post Lower Limb Burn
A study testing Core Stability Exercises, Sensorimotor Training 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 to determine the effect of core stability and sensorimotor training exercises on postural stability post lower limb burn. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Burns
- What is being tested?
- Core Stability Exercises, Sensorimotor Training Exercises and Traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2024to 25 May 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients are both males and females.
- Their age will range from (20-50) years.
- Patients will suffer from lower limb second degree burn (Partial thickness of thermal injury).
- Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
- Patients will begin the training program after complete wound healing.
- Patients will be given their informed consent.
Who cannot join
- Patients who had an open wound at or near treatment site.
- Patients who had chemical or electrical burn.
- Musculoskeletal disorders that will impair performance during training and tests.
- Uncontrolled cardiovascular or pulmonary diseases .
- Neurological and renal disorders.
- Metabolic or vascular disease with a neurological component such as diabetes.
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- Malignant conditions.
- Psychiatric illness, severe behavior or cognitive disorders.
- Uncooperative patients.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khadra Mohamed Ali, PhD contact
Egypt1 site
Faculty of physical therapy, Cairo University
Giza
Rofaida Mohie Eldeen Ali Sobh, M.Sc, 01270214420, sobhrofaida@gmail.com
Khadra Mohamed Ali, PhD
About this study
The purpose of the study is to determine the effect of core stability and sensorimotor training exercises on postural stability post lower limb burn.
Read the detailed description
The need for this study develops from the lack of information in the published studies about the effectiveness of core stability exercises and sensorimotor training on the rehabilitation of burned patients.
Severe burn injuries, particularly those encompassing over 20% of the total body surface area (TBSA), trigger elevated catabolism and hypermetabolic responses in adult and pediatric burn patients. This wide spectrum of pronounced effects stemming from the hypermetabolic response and catabolism includes substantial muscle mass depletion, reduced muscle strength and endurance, hindered wound healing, impaired sensory perception, constrained ambulatory capacity, postural instability, and diminished functional mobility.
Core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function.
Sensorimotor training exercise emphasizes postural control and progressive challenges to the sensorimotor system to restore normal motor programs in patients. The proprio sensory system helps the motor system to maintain equilibrium on a reflex, automatic basis. In response to a sudden load, "the muscles will respond rapidly to stabilize the body, i.e., they will try to maintain balance and posture.
The present study is designed to investigate the effect of core stability and sensorimotor training exercises on postural stability in burned patients.
- Conditions
- Burns
- Being tested
- Core Stability Exercises, Sensorimotor Training 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
Patients will perform core stability exercises three times weekly for eight weeks. The exercises include abdominal hollowing, bridge, right-angle leg lifts with thigh press, seated twist, knee-to-chest with elbow flexion, prone abdominal hollowing, prone arm and leg lift, quadruped abdominal hollowing, quadruped arm or arm-leg lifts, and various plank positions: forearm plank, side plank, forearm plank with hip raise, and forearm plank with straight legs.
Sensorimotor Training ExercisesOther
Patients will perform sensorimotor training exercises three times weekly for eight weeks, progressing through three phases: static (weeks 1-2), dynamic (weeks 3-4), and functional (weeks 5-8). Exercises, repeated 3-5 times per session with rest intervals, advance from simple to complex as patients master each level. Static exercises include standing on firm/soft surfaces and single-leg balances. Dynamic exercises add forward lunges and T-band kicks. Functional training incorporates walking on various surfaces, toe and heel skipping, squats, balance drills on wobble boards, and multidirectional rolling movements with visual and single-leg variations. This progression enhances coordination, balance, and functional stability.
Traditional physical therapy programOther
All patients will undergo a traditional physical therapy program consisting of stretching exercises, strengthening exercises, and scar management techniques, three times weekly for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Core Stability Exercises + Traditional physical therapy program | Experimental | This group will be composed of 30 patients with lower limb burns. Patients will receive core stability exercises in addition to a traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Core Stability Exercises; Other: Traditional physical therapy program |
| Sensorimotor Training Exercises + Traditional physical therapy program | Experimental | This group will be composed of 30 patients with lower limb burns. Patients will receive sensorimotor training exercise in addition to traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Sensorimotor Training Exercises; Other: Traditional physical therapy program |
| Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy program | Experimental | This group will be composed of 30 patients with lower limb burns. Patients will receive core stability exercises and sensorimotor training exercise in addition to traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Core Stability Exercises; Other: Sensorimotor Training Exercises; Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall stability index
It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.
Measured: 8 weeks
anterior-posterior stability index
It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.
Measured: 8 weeks
medial-lateral stability index
It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.
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 posted5 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion25 May 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rofaida Mohie Eldeen Ali Sobh, Cairo University
- Investigators
- Haidy Nady Ashem, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718829
- Sponsor's protocol ID
- P.T.REC/012/005151
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability and Sensorimotor Training Exercises on Postural Stability Post Lower Limb Burn
- ClinicalTrials.gov ID
- NCT06718829
- Acronym / sponsor ID
- P.T.REC/012/005151
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 5 Dec 2024 (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 to determine the effect of core stability and sensorimotor training exercises on postural stability post lower limb burn.
Detailed description
The need for this study develops from the lack of information in the published studies about the effectiveness of core stability exercises and sensorimotor training on the rehabilitation of burned patients.
Severe burn injuries, particularly those encompassing over 20% of the total body surface area (TBSA), trigger elevated catabolism and hypermetabolic responses in adult and pediatric burn patients. This wide spectrum of pronounced effects stemming from the hypermetabolic response and catabolism includes substantial muscle mass depletion, reduced muscle strength and endurance, hindered wound healing, impaired sensory perception, constrained ambulatory capacity, postural instability, and diminished functional mobility.
Core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function.
Sensorimotor training exercise emphasizes postural control and progressive challenges to the sensorimotor system to restore normal motor programs in patients. The proprio sensory system helps the motor system to maintain equilibrium on a reflex, automatic basis. In response to a sudden load, "the muscles will respond rapidly to stabilize the body, i.e., they will try to maintain balance and posture.
The present study is designed to investigate the effect of core stability and sensorimotor training exercises on postural stability in burned patients.
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 + Traditional physical therapy program | Experimental | Other: Core Stability Exercises, Other: Traditional physical therapy programThis group will be composed of 30 patients with lower limb burns. Patients will receive core stability exercises in addition to a traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
| Sensorimotor Training Exercises + Traditional physical therapy program | Experimental | Other: Sensorimotor Training Exercises, Other: Traditional physical therapy programThis group will be composed of 30 patients with lower limb burns. Patients will receive sensorimotor training exercise in addition to traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
| Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy program | Experimental | Other: Core Stability Exercises, Other: Sensorimotor Training Exercises, Other: Traditional physical therapy programThis group will be composed of 30 patients with lower limb burns. Patients will receive core stability exercises and sensorimotor training exercise in addition to traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients are both males and females.
- Their age will range from (20-50) years.
- Patients will suffer from lower limb second degree burn (Partial thickness of thermal injury).
- Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
- Patients will begin the training program after complete wound healing.
Key exclusion criteria (10 listed)
- Patients who had an open wound at or near treatment site.
- Patients who had chemical or electrical burn.
- Musculoskeletal disorders that will impair performance during training and tests.
- Uncontrolled cardiovascular or pulmonary diseases .
- Neurological and renal 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 ExercisesPatients will perform core stability exercises three times weekly for eight weeks. The exercises include abdominal hollowing, bridge, right-angle leg lifts with thigh press, seated twist, knee-to-chest with elbow flexion, prone abdominal hollowing, prone arm and leg lift, quadruped abdominal hollowing, quadruped arm or arm-leg lifts, and various plank positions: forearm plank, side plank, forearm plank with hip raise, and forearm plank with straight legs. | Other | Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy program, Core Stability Exercises + Traditional physical therapy program |
| Sensorimotor Training ExercisesPatients will perform sensorimotor training exercises three times weekly for eight weeks, progressing through three phases: static (weeks 1-2), dynamic (weeks 3-4), and functional (weeks 5-8). Exercises, repeated 3-5 times per session with rest intervals, advance from simple to complex as patients master each level. Static exercises include standing on firm/soft surfaces and single-leg balances. Dynamic exercises add forward lunges and T-band kicks. Functional training incorporates walking on various surfaces, toe and heel skipping, squats, balance drills on wobble boards, and multidirectional rolling movements with visual and single-leg variations. This progression enhances coordination, balance, and functional stability. | Other | Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy program, Sensorimotor Training Exercises + Traditional physical therapy program |
| Traditional physical therapy programAll patients will undergo a traditional physical therapy program consisting of stretching exercises, strengthening exercises, and scar management techniques, three times weekly for eight weeks. | Other | Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy program, Core Stability Exercises + Traditional physical therapy program, Sensorimotor Training Exercises + Traditional physical therapy program |
Primary outcome
overall stability index
Time frame: 8 weeks
It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.
anterior-posterior stability index
Time frame: 8 weeks
It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.
medial-lateral stability index
Time frame: 8 weeks
It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.
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 5 Dec 2024.
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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.
Khadra Mohamed Ali, PhD contact
Haidy Nady Ashem, PhD study chair
Professor, 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, Sensorimotor Training 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 6 inclusion and 10 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 5 Dec 2024. 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 Rofaida Mohie Eldeen Ali Sobh, M.Sc (01270214420, sobhrofaida@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall stability index (time frame: 8 weeks). The study lists 3 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 5 Dec 2024.