- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06718829
Effect of Core Stability and Sensorimotor Training Exercises on Postural Stability Post Lower Limb Burn
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rofaida Mohie Eldeen Ali Sobh, M.Sc
- Phone Number: 01270214420
- Email: sobhrofaida@gmail.com
Study Contact Backup
- Name: Khadra Mohamed Ali, PhD
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, Cairo University
-
Contact:
- Rofaida Mohie Eldeen Ali Sobh, M.Sc
- Phone Number: 01270214420
- Email: sobhrofaida@gmail.com
-
Contact:
- Khadra Mohamed Ali, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Malignant conditions.
- Psychiatric illness, severe behavior or cognitive disorders.
- Uncooperative patients.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core Stability Exercises + Traditional physical therapy program
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.
|
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.
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.
|
|
Experimental: Sensorimotor Training Exercises + Traditional physical therapy program
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.
|
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.
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.
|
|
Experimental: Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy program
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Haidy Nady Ashem, PhD, Professor, Cairo university
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005151
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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