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临床试验/NCT07390825
NCT07390825招募中不适用

Evaluation of the Effects of Aquatic Therapy on Activities of Daily Living, Walking, Balance, Posture, Pain, and Depression in Parkinson's Patients

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
2
主要终点
Parkinson's Disease Questionnaire-39

研究概览

简要总结

Parkinson's Disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms such as bradykinesia, tremors, and postural instability, as well as various non-motor symptoms. Conventional land-based rehabilitation is standard; however, aquatherapy-utilizing water's buoyancy, hydrostatic pressure, and viscosity-offers a promising alternative to improve balance and mobility while reducing fall risks. This study aims to evaluate the effects of aquatherapy on gait, balance, posture, freezing of gait, activities of daily living (ADL), pain, and depression in Turkish PD patients.

This is a prospective, single-blind, randomized controlled trial involving 42 patients at Ankara City Hospital. Participants will be divided into two groups:

  • Group 1 (Control): Home-based exercise program (5 days/week for 6 weeks).
  • Group 2 (Intervention): Home-based exercises plus supervised aquatherapy (3 sessions/week, 45 minutes each, in a 30-32°C pool).

The study utilizes high-tech objective measurements and validated scales:

  • Gait & Posture: Zebris Gait Analysis (spatiotemporal parameters) and Diers Formetric 4D (topographical posture analysis).
  • Balance: HUR-Smart Balance device and the Berg Balance Scale.
  • Clinical Scales: PDQ-39 (quality of life), Freezing of Gait Questionnaire, Falls Efficacy Scale, MMSE (cognitive), Beck Depression Inventory, and VAS (pain).

This research is noteworthy as the first aquatherapy study among Turkish PD patients to utilize a large sample size and standardized aquatic exercise protocols. It seeks to provide a comprehensive analysis of both motor and non-motor improvements, potentially establishing aquatherapy as a superior adjunctive treatment for enhancing functional independence in Parkinson's patients.

Primary hypothesis or outcome measure : Parkinson's Disease Questionnaire-39 . PDQ-39 is a patient-reported outcome measure designed to evaluate the health-related quality of life in Parkinson's patients across eight specific domains, including mobility, activities of daily living, and emotional well-being.

详细描述

Abstract / Project Description Parkinson's Disease (PD) is a progressive neurodegenerative disorder characterized by the degeneration of dopamine-producing cells in the substantia nigra, ranking as the second most common neurodegenerative disease after Alzheimer's. The prevalence of the disease in Turkey is approximately 2/1000. The primary symptoms of Parkinson's disease include bradykinesia, resting tremor, rigidity, and postural instability. Posture, balance, and gait disturbances are significant findings that emerge during the course of the disease, causing severe disability. The gait pattern in PD varies across different stages and affects patients to varying degrees. Typically, a shortening of step length, patients walk slowly with small steps. In advanced stages, difficulty in initiating gait, freezing of gait, and postural instability are frequently developing symptoms. In addition to classic motor findings, non-motor symptoms such as urinary incontinence, sexual dysfunction, orthostatic hypotension, sleep disorders, depression, anxiety, and pain may also be observed.

The Modified Hoehn & Yahr Staging is a scale used to stage Parkinson's disease, with proven validity and reliability in Turkish. Developed by Hoehn and Yahr in 1967, this system allows both the patient and the clinician to easily define the severity of the disease and evaluate its progression across five stages. In the literature, Stages 1 and 2 are classified as "mild," Stage 3 as "moderate," and Stages 4 and 5 as "severe".

As conventional rehabilitation therapy, Parkinson's patients are frequently prescribed land-based gait and mobilization, posture, relaxation exercises, occupational therapy, and respiratory and swallowing exercises. Whether combined with other therapies or not, aquatherapy improves balance and functional mobility in PD patients compared to conventional rehabilitation. Aquatherapy, developed to improve balance, make walking more functional, and minimize strength imbalances between muscles, is considered a viable method for PD .

Aquatherapy is a rehabilitation method based on exercises performed in water using the physical properties of water . It is beneficial in the treatment of musculoskeletal, neurological, and cardiopulmonary diseases, among other conditions. The therapeutic safety margin of aquatherapy is quite broad . During treatment, the physical properties of water are utilized: hydrostatic pressure increases lymphatic and venous return in the extremities, contributing to the reduction of edema. Due to the buoyancy of water, patients move more comfortably; body weight is reduced by 90% with immersion up to the cervical region and by 60% up to the xiphoid process . Because of water's viscosity, resistance to movement is higher than in air, allowing movements to be performed at a constant speed. This resistance makes water an effective environment for strengthening. Additionally, heat can be retained or transferred through the thermodynamic effect of water . Aquatherapy is recognized as an effective adjunctive treatment in PD, particularly for improving motor symptoms . It reduces pressure on the joints, alleviates pain, provides support during movement, and reduces the risk of falling, thereby helping patients improve their balance skills .

In this study, the aquatherapy exercise program will be conducted in a therapy pool with a depth of 120 cm. Patients will be recommended to wear aquatic shoes to prevent slipping. Access to the pool will be provided via a lift. The water temperature will be maintained at 30-32°C. The aim of this study is to investigate the effects of aquatherapy on gait, balance, posture, freezing, activities of daily living (ADL), pain, and depression in Parkinson's patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The study was designed as a single-blind trial, where participants were kept unaware of their group assignments.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of Idiopathic Parkinson's Disease between the ages of 40-80 and consenting to the treatment.
  • Being regularly followed by a neurologist and having a stable medical treatment regimen for at least 3 months.
  • Having a disease stage between 1-3 according to the Modified Hoehn-Yahr Staging Scale (MHY).
  • A score of 24 or higher on the Mini-Mental State Examination (MMSE).
  • Being able to verticalize independently and ambulate with or without assistance.

排除标准

  • Having orthopedic, rheumatological, or non-Parkinson's neurological disorders that affect functional status.
  • Having a medical treatment regimen that has been modified within the last 3 months.
  • Presence of Atypical Parkinson's Disease.
  • Visual impairment.
  • Presence of dementia.
  • Decompensated cardiac or respiratory failure.
  • Diabetes insipidus.
  • Presence of systemic infection.
  • Impaired skin integrity or the presence of skin infections.
  • Increased sensitivity to inhaled steam or water chemicals.
  • History of epilepsy or asthma.
  • Urinary or fecal incontinence.
  • Refusal to participate in or consent to the treatment.

研究组 & 干预措施

Arm 1: Control Group (Home-based Exercise)

Experimental

Control Group (Home-based Exercise)

干预措施: home exercise (Other)

Arm2: Experimental Group

Experimental

Experimental Group (Aquatherapy + Home-based Exercise)

干预措施: Aquatherapy (Other)

结局指标

主要结局

Parkinson's Disease Questionnaire-39

时间窗: From enrollment to the end of treatment at 6 weeks

Patients' quality of life will be evaluated using the Parkinson's Disease Questionnaire-39 (PDQ-39).The PDQ-39 is a 39-item questionnaire that covers eight distinct dimensions of functioning and well-being. The domains include: Mobility , Activities of Daily Living, Emotional Well-being , Stigma, Social Support, Cognition, Communicatio, Bodily Discomfort.The questionnaire uses a 5-point Likert response format where patients rate their experiences from "never" (0) to "always" (4). For each of the eight dimensions, a score is calculated and normalized to a 0-100 scale using the formula:Dimension Score = (Sum of Item Scores / Maximum Possible Score for Dimension) × 100 each dimension the minimum possible score is 0 and the maximum possible score is 100 after normalization. Considering the entire PDQ-39, the raw total score ranges from 0 to 156, where 0 represents the best possible quality of life and 156 the worst possible quality of life.

次要结局

  • Berg Balance Scale(From enrollment to the end of treatment at 6 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu Yanıktaş

Assistant Doctor

Ankara City Hospital Bilkent

研究点 (2)

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