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Enrolling by Invitation

NCT Number: NCT06862635

Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn

Balance problems are common among neuropathic patients following burns, primarily due to sensory and motor impairments.The goal of the study is to investigate the effect of a hydrotherapy program on balance in neuropathic patients following burns. It is a randomized controlled study will be conducted on fifty male patients (age range from 35 to 45 years) with polyneuropathy following lower limb burn injuries, mainly at the sole of the foot, with 3rd-degree injuries and 30% burn extent.

Balance will be assessed before and after treatment using the Biodex Balance System and the Berg Balance Scale (BBS).

Patients will be randomly assigned into two equal groups:

Group A (study group) will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water.

Group B (control group) will receive traditional land-based balance exercises only.

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Key information

Conditions

Neuropathy Burn Burns Wounds and Injuries

Age range

35 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kasr alainy

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • polyneuropathy following burn injuries of the lower limb mainly at the sole of the foot.
  • 3rd-degree injuries and 30% burn extent.
  • Patients' ages range from 35 to 45 years,
  • Ability to understand instructions and following commands.

Exclusion criteria

  • balance disturbances due to neurological disorders other than polyneuropathy (e.g., Parkinson's disease, inner ear disorders, vestibular or cerebellar dysfunctions).
  • Uncontrolled hypertension.
  • Diabetes mellitus,
  • Cognitive impairments
  • Blindness.
  • Deafness.
  • Significant respiratory or cardiac conditions.

Treatment and study plan

Hydrotherapy

Other

Patients will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water

traditional land-based balance exercises

Other

Patients will receive traditional land-based balance exercises in the form of stretching, strengthening and balance exercises.

Primary outcomes

  1. Balance assessment (Biodex Balance System)

    Time frame: Balance will be assessed by bode balance system before the first session and after 12 sessions (3 months)

    The Biodex Balance System is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress. It uses a circular platform that is free to move in the anterior-posterior and medial-lateral axes simultaneously. It can also be used for the purpose of balance training.

Secondary outcomes

  1. Balance assessment (Berg Balance Scale)

    Time frame: Berg balance scale will be recorded before the fisrt session and after 12 sessions (3 months)

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Jul 8, 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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