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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Burn; Neuropathy
• Intervention / Treatment: Other: Hydrotherapy; Other: traditional land-based balance exercises

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Kasr Alainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrotherapy group	Other: Hydrotherapy; Patients will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water
Active Comparator: Land Based exercise group	Other: traditional land-based balance exercises; Patients will receive traditional land-based balance exercises in the form of stretching, strengthening and balance exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance assessment (Biodex Balance System)	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.	Balance will be assessed by bode balance system before the first session and after 12 sessions (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance assessment (Berg Balance Scale)	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.	Berg balance scale will be recorded before the fisrt session and after 12 sessions (3 months)

Collaborators and Investigators

• Sponsor: MTI University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): August 5, 2025
• Study Completion (Estimated): August 10, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: P.T.REC/012/005840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No