Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn

NCT ID: NCT06862635

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-08-10

Brief Summary

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.

Conditions

Neuropathy; Burn

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hydrotherapy group

Group Type: EXPERIMENTAL

Hydrotherapy

Intervention Type: OTHER

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

Land Based exercise group

Group Type: ACTIVE_COMPARATOR

traditional land-based balance exercises

Intervention Type: OTHER

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

Interventions

Hydrotherapy

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

Intervention Type: OTHER

traditional land-based balance exercises

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Fayek Hammam

Lecturer at faculty of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr alainy

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005840

Identifier Type: -

Identifier Source: org_study_id