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

NCT ID: NCT07017764

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2025-10-26

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Core stability exercises + Theraband resisted exercises + Traditional physical therapy program

This group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive core stability and theraband resisted exercises in addition to a traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises. Exercises will be applied for 3 times a week for 8 consecutive weeks.

Group Type: EXPERIMENTAL

Core stability exercises

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Core stability exercises + Traditional physical therapy program

This group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive core stability exercises in addition to traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises.

Exercises will be applied for 3 times a week for 8 consecutive weeks.

Group Type: ACTIVE_COMPARATOR

Core stability exercises

Intervention Type: 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.

Traditional physical therapy program

Intervention Type: 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.

Theraband resisted exercises + Traditional physical therapy program

This group will be composed of 22 patients with second degree lower limb burn of thermal injury. Patients will receive theraband resisted exercises in addition to traditional physical therapy program in the form of ambulation, stretching exercises for the muscles of the lower limbs and range of motion exercises. Exercises will be applied for 3 times a week for 8 consecutive weeks.

Group Type: ACTIVE_COMPARATOR

Theraband resisted exercises

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Noura Mohamed Fouad Hussein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Mohamed Othman, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Tarek Ahmed Amer, PhD

Role: STUDY_DIRECTOR

Professor, Cairo university

Noha Mohamed Kamel, PhD

Role: STUDY_DIRECTOR

Lecturer, Cairo university

Locations

El Mahalla General Hospital and Burn Center in Mansoura University Hospital

Al Mansurah, , Egypt

Countries

Egypt

Central Contacts

Noura Mohamed Fouad Hussein, B.Sc

Role: CONTACT

nouranew2022@gmail.com

+20 102 690 2134

Noha Mohamed Kamel, PhD

Role: CONTACT

Facility Contacts

Noura Mohamed Fouad Hussein, B.Sc

Role: primary

nouranew2022@gmail.com

+20 102 690 2134

Other Identifiers

P.T.REC/012/005543

Identifier Type: -

Identifier Source: org_study_id