NCT07390825

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Aug 2026

Study Start

First participant enrolled

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

January 23, 2026

Last Update Submit

February 1, 2026

Conditions

Keywords

Parkinson's DiseaseAquatherapyRehabilitation of Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Parkinson's Disease Questionnaire-39

    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.

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (1)

  • Berg Balance Scale

    From enrollment to the end of treatment at 6 weeks.

Study Arms (2)

Arm 1: Control Group (Home-based Exercise)

EXPERIMENTAL

Control Group (Home-based Exercise)

Other: home exercise

Arm2: Experimental Group

EXPERIMENTAL

Experimental Group (Aquatherapy + Home-based Exercise)

Other: Aquatherapy

Interventions

The specific aquatic exercise protocol for Group 2, conducted in a 120 cm deep therapy pool at 30-32°C, includes the following exercises: Gait and Mobility: Water walking (forward and backward) and side-stepping. Dynamic Balance: Forward and lateral lunges, and single-leg stance/balance drills. Lower Extremity Strengthening: Hip kicks performed at the pool wall (flexion, extension, and abduction) and standing knee raises. Upper Body and Coordination: Arm raises (multi-directional) and deep-water cycling movements. Home Exercise Component: In addition to aquatic sessions, patients will continue land-based exercises including posture correction, flexibility/stretching, balance-coordination training, and strengthening.

Arm2: Experimental Group

Group 1 patients will be prescribed a home exercise program at least 5 days per week for a duration of 6 weeks

Arm 1: Control Group (Home-based Exercise)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bilkent City Hospital

Çankaya, Ankara, 06800, Turkey (Türkiye)

RECRUITING

Bilkent City Hospital

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Pinto C., et al. (2019). "The Effects of Hydrotherapy on Balance, Functional Mobility, Motor Status, and Quality of Life in Patients with Parkinson Disease: A Systematic Review and Meta-analysis", PM R, 11(3), 278-291. https://doi.org/10.1016/j.pmrj.2018.09.031

    BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Halil Uçan, Prof. Doctor

    Bilkent City Hospital

    STUDY DIRECTOR

Central Study Contacts

Duygu Yanıktaş, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study was designed as a single-blind trial, where participants were kept unaware of their group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Doctor

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 5, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly to protect patient confidentiality and ensure strict adherence to personal data protection laws. The raw data contains sensitive health information that could potentially lead to the de-identification of participants, which would violate the ethical terms outlined in the informed consent forms

Locations