NCT06862635

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

July 8, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 25, 2025

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Balance assessment (Berg Balance Scale)

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

Study Arms (2)

Hydrotherapy group

EXPERIMENTAL
Other: Hydrotherapy

Land Based exercise group

ACTIVE COMPARATOR
Other: traditional land-based balance exercises

Interventions

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

Hydrotherapy group

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

Land Based exercise group

Eligibility Criteria

Age35 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy

Giza, Egypt

Location

MeSH Terms

Conditions

Burns

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at faculty of Physical Therapy

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 6, 2025

Study Start

May 5, 2025

Primary Completion

August 5, 2025

Study Completion

August 10, 2025

Last Updated

July 8, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations