NeuropathyNCT06862635
Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn
A study testing Hydrotherapy and traditional land-based balance exercises in people with Neuropathy and Burn, run by MTI University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Neuropathy, Burn
- What is being tested?
- Hydrotherapy and traditional land-based balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2025to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read more
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
- Being tested
- Hydrotherapy, traditional land-based balance exercises
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrotherapyOther
Patients will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water
traditional land-based balance exercisesOther
Patients will receive traditional land-based balance exercises in the form of stretching, strengthening and balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Hydrotherapy group | Experimental | Not described Receives: Other: Hydrotherapy |
| Land Based exercise group | Active comparator | Not described Receives: Other: traditional land-based balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Berg balance scale will be recorded before the fisrt session and after 12 sessions (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start5 May 2025
- Primary completion5 Aug 2025 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Fayek Hammam, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862635
- Sponsor's protocol ID
- P.T.REC/012/005840
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn
- ClinicalTrials.gov ID
- NCT06862635
- Acronym / sponsor ID
- P.T.REC/012/005840
- Conditions
- Neuropathy, Burn
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Aug 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrotherapy group | Experimental | Other: Hydrotherapy |
| Land Based exercise group | Active comparator | Other: traditional land-based balance exercises |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrotherapyPatients will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water | Other | Hydrotherapy group |
| traditional land-based balance exercisesPatients will receive traditional land-based balance exercises in the form of stretching, strengthening and balance exercises. | Other | Land Based exercise group |
Primary outcome
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.
1 secondary outcome
Balance assessment (Berg Balance Scale)
Time frame: Berg balance scale will be recorded before the fisrt session and after 12 sessions (3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotherapy and traditional land-based balance exercises in people with Neuropathy and Burn, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.