Effect of Hydrotherapy On Pain, Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydrotherapy training, Land training.
- Who it may be relevant to
- Registry conditions: Diabetic Peripheral Neuropathy. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Hydrotherapy training
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. - Other Land training
The patients do the same exercise of the experimental group on land three days per week for 12 weeks.
Primary outcome measures
- Toronto Clinical Neuropathy Score [Time frame: 12 weeks]
- McGill pain assessment questionnaire [Time frame: 12 weeks]
- Berg balance scale [Time frame: 12 weeks]
Secondary outcome measures (1)
- Diabetes self-Care Activities measurement [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Beni-Suef university hospital — Banī Suwayf
Identifiers
NCT: NCT07260214 · FPTBSUREC/0305/2325