Clinical trial NCT07017764: Combined Effect of Core Stability and Theraband Resisted Exercises on Gait Parameters in Lower Limb Burn
Official title: Combined Effect of Core Stability and Theraband Resisted Exercises on Gait Parameters in Lower Limb Burn
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Step length
timeFrame: 8 weeks
measure: Stride length
timeFrame: 8 weeks
measure: Step width
timeFrame: 8 weeks
measure: Step time
timeFrame: 8 weeks
measure: Stride time
timeFrame: 8 weeks
measure: Cadence
timeFrame: 8 weeks
measure: Velocity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: El Mahalla General Hospital and Burn Center in Mansoura University Hospital
Study officials:
affiliation: Professor, Cairo university
name: Eman Mohamed Othman, PhD
role: STUDY_CHAIR
affiliation: Professor, Cairo university
name: Tarek Ahmed Amer, PhD
role: STUDY_DIRECTOR
affiliation: Lecturer, Cairo university
name: Noha Mohamed Kamel, PhD
role: STUDY_DIRECTOR
References: