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

NCT07017764 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005543
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (7)

• Step length

  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.

  8 weeks

• Stride length

  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.

  8 weeks

• Step width

  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.

  8 weeks

• Step time

  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.

  8 weeks

• Stride time

  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.

  8 weeks

• Cadence

  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.

  8 weeks

• Velocity

  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.

  8 weeks

Study Arms (3)

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

EXPERIMENTAL

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.

Other: Core stability exercises; Other: Theraband resisted exercises; Other: Traditional physical therapy program

Core stability exercises + Traditional physical therapy program

ACTIVE COMPARATOR

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.

Other: Core stability exercises; Other: Traditional physical therapy program

Theraband resisted exercises + Traditional physical therapy program

ACTIVE COMPARATOR

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.

Other: Theraband resisted exercises; Other: Traditional physical therapy program

Interventions

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.

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

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.

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

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.

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

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El Mahalla General Hospital and Burn Center in Mansoura University Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Eman Mohamed Othman, PhD

  Professor, Cairo university

  STUDY CHAIR

• Tarek Ahmed Amer, PhD

  Professor, Cairo university

  STUDY DIRECTOR

• Noha Mohamed Kamel, PhD

  Lecturer, Cairo university

  STUDY DIRECTOR

Central Study Contacts

Noura Mohamed Fouad Hussein, B.Sc

CONTACT

+20 102 690 2134; nouranew2022@gmail.com

Noha Mohamed Kamel, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: June 11, 2025
• Primary Completion: October 11, 2025
• Study Completion: October 26, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

EG (1)