Diabetic Peripheral NeuropathyNCT07260214
Effect of Hydrotherapy On Pain, Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy
A study testing Hydrotherapy training and Land training in people with Diabetic Peripheral Neuropathy, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The current study aims to investigate the effects of hydrotherapy compared to land-based training on patients with diabetic peripheral neuropathy. It will evaluate hydrotherapy's impact on pain relief, sensation improvement, balance, and overall quality of life for these patients. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Hydrotherapy training and Land training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Mar 2026
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetic peripheral neuropathy due to type 2 diabetes mellitus of both sex Patients must have confirmed diagnosis of diabetic peripheral neuropathy based on clinical symptoms (E.G, numbness, tingling and burning pain) and diagnostic test such as nerve conduction studies
- Chronicity of type 2 diabetes mellitus more than 10 years
- Age range: between 40-65years old
- Stable Blood Glucose Levels HbA1c (≤5.7)
- No active infections or wound
Who cannot join
- Severe Renal Impairment.
- Uncontrolled cardiovascular diseases
- Pregnancy
- Neurological or musculoskeletal conditions
- Inability to safely enter or exit the pool
- Uncontrolled infections
- Vitamin B12 deficiency.
- Postural hypotension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tamer Ibrahim Abo Elyazed, PhD contact
Egypt1 site
Beni-Suef university hospital
Banī Suwayf
Aya Yasser Saber Mahmoud, B.Sc, +201559406122, Ayayassersaber@gmail.com
About this study
The current study aims to investigate the effects of hydrotherapy compared to land-based training on patients with diabetic peripheral neuropathy. It will evaluate hydrotherapy's impact on pain relief, sensation improvement, balance, and overall quality of life for these patients.
Read the detailed description
Hydrotherapy training is a rehabilitative approach proposed for different medical conditions, the hydrotherapy environment facilitates patients with functional limitations, who feel a safer setting and are consequently more motivated to the training. The physical properties of water help to improve patient stability and to allow limbs movements by offloading the body weight and Exerting resistance against the body segments and giving proprioceptive inputs.
Moreover, the warmth of hydrotherapy pool helps muscle relaxation and seems to reduce pain perception, aiming to improve blood circulation so that nutrients can be distributed more smoothly to body tissues, strengthen small muscles, calves, and thighs, as well as address joint mobility limitations often experienced by diabetes mellitus patients.
Several authors evaluated hydrotherapy therapy as possible gait and balance training of neurological patients and demonstrated beneficial effects mostly in Parkinson's disease and stroke. Limited number of studies, even if affected by small sample sizes, made a comparison between hydrotherapy training and on land training. Showing best balance results of the former for the same diseases.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Hydrotherapy training, Land training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrotherapy trainingOther
The patients will participate in hydrotherapy sessions three days per week for 12 weeks in a heated swimming pool maintained at 32°C. Each session will include a sequence of activities: relaxation and breath control, balance exercises, gait training, and hydrotherapy cycling.
Land trainingOther
The patients do the same exercise of the experimental group on land three days per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hydrotherapy training | Experimental | This group will consist of seventeen diabetic peripheral neuropathy patients will perform hydrotherapy training for 12 weeks. Receives: Other: Hydrotherapy training |
| Land training | Active comparator | This group will consist of seventeen diabetic peripheral neuropathy patients will do land training for 12 weeks. Receives: Other: Land training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Clinical Neuropathy Score
The Toronto Clinical Neuropathy Score (TCNS) is a validated tool for diagnosing and monitoring diabetic sensorimotor peripheral neuropathy (DSPN). It ranges from 0 to 19 points, comprising six points from symptom scores, eight points from lower limb reflexes, and five points from sensory examinations at the toes. The total score categorizes neuropathy severity as follows: 0-5 indicates no neuropathy, 6-8 mild neuropathy, 9-11 moderate neuropathy, and 12 or more indicates severe neuropathy. This scoring system helps clinicians accurately assess neuropathy progression and guide patient management.
Measured: 12 weeks
McGill pain assessment questionnaire
The McGill Pain Questionnaire is a tool used to assess and quantify the severity and characteristics of neuropathic pain, which results from nerve damage or dysfunction. It evaluates pain intensity on a 0-10 scale, where 0 means "no pain" and 10 is the worst possible pain. Patients describe their pain quality using terms like burning, stabbing, electric shock-like, tingling, numbness, and itching. The scoring reflects pain severity, with higher scores indicating more intense pain. This multidimensional tool helps clinicians understand pain characteristics and guide treatment decisions effectively.
Measured: 12 weeks
Berg balance scale
The Berg Balance Scale (BBS) is a widely recognized tool for assessing balance, consisting of 14 items scored on an ordinal scale from 0 to 4, with a total score of 56. Lower scores indicate higher fall risk, where 0 represents the lowest function and 4 the highest. The test typically takes about 20 minutes. Functional levels based on scores include 0-20 indicating ability to walk with a walking aid, 21-40 suggesting walking with assistance, and 41-56 indicating independent walking. The BBS is also used as a fall risk predictor: scores of 41-56 indicate low risk, 21-40 medium risk, and 0-20 high risk.
Measured: 12 weeks
Secondary outcomes (1)
Diabetes self-Care Activities measurement
The Self-Care Activities (SDSCA) scale, developed by Wan Qiaoqin of Peking University, China, will be used to measure the self-care level of patients with diabetic peripheral neuropathy. This scale includes 11 items across six dimensions: general diet, special diet, exercise, blood glucose monitoring, foot care, and medication adherence. Each item will be scored on an eight-point scale from 0 to 7, reflecting the frequency of self-care activities performed by the patients.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Yasser Saber Mahmoud, Beni-Suef University
- Investigators
- Tamer Ibrahim Abo Elyazed, PhD, Study chair, Assistant Professor, Beni-Suef UniversityReham Ali Mohamed Ali, PhD, Study director, Lecturer, Beni-Suef UniversityAhmed Moheyeldien Hamed, PhD, Study director, Lecturer, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260214
- Sponsor's protocol ID
- FPTBSUREC/0305/2325
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrotherapy On Pain, Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07260214
- Acronym / sponsor ID
- FPTBSUREC/0305/2325
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 Dec 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.
The current study aims to investigate the effects of hydrotherapy compared to land-based training on patients with diabetic peripheral neuropathy. It will evaluate hydrotherapy's impact on pain relief, sensation improvement, balance, and overall quality of life for these patients.
Detailed description
Hydrotherapy training is a rehabilitative approach proposed for different medical conditions, the hydrotherapy environment facilitates patients with functional limitations, who feel a safer setting and are consequently more motivated to the training. The physical properties of water help to improve patient stability and to allow limbs movements by offloading the body weight and Exerting resistance against the body segments and giving proprioceptive inputs.
Moreover, the warmth of hydrotherapy pool helps muscle relaxation and seems to reduce pain perception, aiming to improve blood circulation so that nutrients can be distributed more smoothly to body tissues, strengthen small muscles, calves, and thighs, as well as address joint mobility limitations often experienced by diabetes mellitus patients.
Several authors evaluated hydrotherapy therapy as possible gait and balance training of neurological patients and demonstrated beneficial effects mostly in Parkinson's disease and stroke. Limited number of studies, even if affected by small sample sizes, made a comparison between hydrotherapy training and on land training. Showing best balance results of the former for the same diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrotherapy training | Experimental | Other: Hydrotherapy trainingThis group will consist of seventeen diabetic peripheral neuropathy patients will perform hydrotherapy training for 12 weeks. |
| Land training | Active comparator | Other: Land trainingThis group will consist of seventeen diabetic peripheral neuropathy patients will do land training for 12 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of diabetic peripheral neuropathy due to type 2 diabetes mellitus of both sex Patients must have confirmed diagnosis of diabetic peripheral neuropathy based on clinical symptoms (E.G, numbness, tingling and burning pain) and diagnostic test such as nerve conduction studies
- Chronicity of type 2 diabetes mellitus more than 10 years
- Age range: between 40-65years old
- Stable Blood Glucose Levels HbA1c (≤5.7)
- No active infections or wound
Key exclusion criteria (8 listed)
- Severe Renal Impairment.
- Uncontrolled cardiovascular diseases
- Pregnancy
- Neurological or musculoskeletal conditions
- Inability to safely enter or exit the pool
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 |
|---|---|---|
| Hydrotherapy trainingThe patients will participate in hydrotherapy sessions three days per week for 12 weeks in a heated swimming pool maintained at 32°C. Each session will include a sequence of activities: relaxation and breath control, balance exercises, gait training, and hydrotherapy cycling. | Other | Hydrotherapy training |
| Land trainingThe patients do the same exercise of the experimental group on land three days per week for 12 weeks. | Other | Land training |
Primary outcome
Toronto Clinical Neuropathy Score
Time frame: 12 weeks
The Toronto Clinical Neuropathy Score (TCNS) is a validated tool for diagnosing and monitoring diabetic sensorimotor peripheral neuropathy (DSPN). It ranges from 0 to 19 points, comprising six points from symptom scores, eight points from lower limb reflexes, and five points from sensory examinations at the toes. The total score categorizes neuropathy severity as follows: 0-5 indicates no neuropathy, 6-8 mild neuropathy, 9-11 moderate neuropathy, and 12 or more indicates severe neuropathy. This scoring system helps clinicians accurately assess neuropathy progression and guide patient management.
McGill pain assessment questionnaire
Time frame: 12 weeks
The McGill Pain Questionnaire is a tool used to assess and quantify the severity and characteristics of neuropathic pain, which results from nerve damage or dysfunction. It evaluates pain intensity on a 0-10 scale, where 0 means "no pain" and 10 is the worst possible pain. Patients describe their pain quality using terms like burning, stabbing, electric shock-like, tingling, numbness, and itching. The scoring reflects pain severity, with higher scores indicating more intense pain. This multidimensional tool helps clinicians understand pain characteristics and guide treatment decisions effectively.
Berg balance scale
Time frame: 12 weeks
The Berg Balance Scale (BBS) is a widely recognized tool for assessing balance, consisting of 14 items scored on an ordinal scale from 0 to 4, with a total score of 56. Lower scores indicate higher fall risk, where 0 represents the lowest function and 4 the highest. The test typically takes about 20 minutes. Functional levels based on scores include 0-20 indicating ability to walk with a walking aid, 21-40 suggesting walking with assistance, and 41-56 indicating independent walking. The BBS is also used as a fall risk predictor: scores of 41-56 indicate low risk, 21-40 medium risk, and 0-20 high risk.
1 secondary outcome
Diabetes self-Care Activities measurement
Time frame: 12 weeks
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 3 Dec 2025.
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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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.
Tamer Ibrahim Abo Elyazed, PhD contact
Tamer Ibrahim Abo Elyazed, PhD study chair
Assistant Professor, Beni-Suef University
Reham Ali Mohamed Ali, PhD study director
Lecturer, Beni-Suef University
Ahmed Moheyeldien Hamed, PhD study director
Lecturer, Beni-Suef University
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 training and Land training in people with Diabetic Peripheral Neuropathy, run by Beni-Suef 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Dec 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?
Contact Aya Yasser Saber Mahmoud, B.Sc (+201559406122, Ayayassersaber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Clinical Neuropathy Score (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 3 Dec 2025.