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Not yet recruiting NCT07017764

Combined Effect of Core Stability and Theraband Resisted Exercises on Gait Parameters in Lower Limb Burn

No phase Interventional Burns

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Core stability exercises, Theraband resisted exercises, Traditional physical therapy program.
Who it may be relevant to
Registry conditions: Burns. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Core stability exercises
    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.
  • Other Theraband resisted exercises
    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 rep
  • Other Traditional physical therapy program
    All patients will receive a traditional physical therapy program consisting of ambulation training, stretching exercises for lower limb muscles, and range of motion exercises.

Primary outcome measures

  • Step length [Time frame: 8 weeks]
  • Stride length [Time frame: 8 weeks]
  • Step width [Time frame: 8 weeks]
  • Step time [Time frame: 8 weeks]
  • Stride time [Time frame: 8 weeks]
  • Cadence [Time frame: 8 weeks]
  • Velocity [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • El Mahalla General Hospital and Burn Center in Mansoura University Hospital — Al Mansurah

Identifiers

NCT: NCT07017764 · P.T.REC/012/005543

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗