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Completed

NCT Number: NCT05749003

Sensorimotor Training Exercise After Lower Extremity Burns

Burn injury affects dermal tissue which contains sensory neurones that contribute to the conscious and automatic feedback systems which in turn, control balance and coordination. Impediments arising from lower limb burn injuries are similar to those observed in other populations suffering lower limb disease or pathology and further, these complications cause balance dysfunction. Balance and mobility are complex bodily functions integral to discharge disposition, social function and quality of life. Therefore, to guide recovery accurately and facilitate rehabilitation after LLBI, multi-factorial assessment is required.

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Key information

Conditions

Lower Extremity Burns Burns Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nesma Morgan Allam

Tanta, 12111, Egypt

About this study

Burns to the lower limbs can cause pain, scar tissue contracture, impaired sensation, muscle weakness and postural imbalance are all potential complications of lower limb burn injury (LLBI) which negatively influence a person's ability to function normally

Sensorimotor training is a special form of proprioceptive and balance exercise that was designed for management of patients with chronic musculoskeletal pain syndromes. It is based on the concept that instead of emphasizing the isolated strength of a group of muscles around a joint, we should realize the importance of the central nervous system in regulating movement in order to reach proper firing patterns for maintaining joint stability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of thermal burn injuries at the lower extremities.
  • Total body surface area burned approximately from 40 to 50%.
  • Patients age: 20 to 50 years.

Exclusion criteria

  • Cognitive or mentality dysfunctions.
  • Psychiatric conditions.
  • Fractures.
  • Pregnancy.
  • Cancer.
  • Severe vascular complications.

Treatment and study plan

sensorimotor training exercise

Other

Patients will be trained through three stages: static, dynamic and functional. Each exercise will be repeated 3-5 times during a session and with enough periods of rest between each set of exercises. The exercise graduated from easy to more difficult and the patient was not progressed to a more difficult stage until performing the easier one.

conventional physical therapy program of exercise.

Other

stretching exercise for 30 minutes, then strengthening exercise and usual burn care for the lower extremity. Exercises will be applied for 3 times a week for 8 consecutive weeks.

Primary outcomes

  1. Stability assessment

    Time frame: 2 months

    Biodex balance scale (Biodex medical systems Inc, Shirley, New York, USA), will be used for balance assessment. Anteroposterior stability index, mediolateral stability index, and overall stability index will be used to assess fluctuations around the zero point representing standard deviations rather than around a group mean.

  2. Balance assessment

    Time frame: 2 months

    The Berg balance scale includes 14 items with scores from 0 to 4. A score of 0 represents the inability to do the task, while a score of 4 represents the ability to do the task completely, according to the assigned criteria, with 56 indicates the total score.

Secondary outcomes

  1. Mobility assessment

    Time frame: 2 months

    For assessment of mobility, the timed-up and go test was used. The test asks the participant to raise up from the sitting position followed by walking for 3 m, turning around, sitting again on the chair with his back supported, and resting his arms on the armrests. A stopwatch was used to measure the time in seconds for each participant to finish the task. The test was repeated for three trials, and the best or lowest trial time was documented for analysis.

  2. Quality of life (36-Item Short Form Health Survey (SF-36).

    Time frame: 2 months

    HRQoL using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). The SF-36 is a generic measure of HRQoL that contains 36 items grouped into: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Scores on each subscale range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status.

  3. Muscle Torque assessment

    Time frame: 2 months

    The therapist will perform the initial evaluation of knee extensor muscles of the dominant burned limb with Biodex isokinetic dynamometer (Biodex Medical System, Shiley, NY, USA, linked to IBM PC-computer software). After a 5-min warm-up on the treadmill without resistance, the participants will be positioned in an isokinetic dynamometer with hip angle of 100°. The trunk, pelvis and thigh will be stabilized using straps, in accordance with the Test and Rehabilitation System User's Guide of Biodex.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Sensorimotor Training Exercise After Lower Extremity Burns, Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 1, 2023
Registry last updated
Sep 20, 2024

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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