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NCT Number: NCT07017764

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Mahalla General Hospital and Burn Center in Mansoura University Hospital

Al Mansurah, Egypt

Location contact

Noura Mohamed Fouad Hussein, B.Sc

CONTACT

[email protected]

+20 102 690 2134

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Core Stability Exercises

Other

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 exercises

Other

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 program

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Noha Mohamed Kamel, PhD

CONTACT

Noura Mohamed Fouad Hussein, B.Sc

CONTACT

[email protected]

+20 102 690 2134

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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