Effects of Land and Water Physiotherapy on Motor Function in Parkinson's Disease

NCT ID: NCT05866120

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2024-12-15

Brief Summary

The aim of this study is to assess the effect of dry soil therapy and shallow water therapy on motor function in individuals with Parkinson's disease. Regarding the benefits, is there a difference between the therapies?

Detailed Description

Parkinson's disease (PD) is a chronic progressive neurological disorder that involves motor and non-motor symptoms that commonly include bradykinesia, rigidity, tremor and postural instability and culminates in functional decline and disability. Postural instability is due to postural alterations that are commonly found in these individuals. Muscular disorders characterized by the inability to generate adequate synergy patterns may be responsible for postural instability, leading to postural alterations in the sagittal plane, often with the onset of hyperkyphosis. Exercise is increasingly being recognized as an effective and highly promising non-pharmacological intervention to improve muscle strength in PD. Typical land-based physical therapy treatment includes strength training, gait and balance training and has several benefits in reducing motor symptoms of PD. Interventions such as aquatic physical therapy have a growing body of evidence to support the efficacy of exercise in the PD population. Aquatic exercise has the intrinsic advantage of helping individuals lose body weight, leading to greater efficacy of the exercise itself. Knowing that muscle strength is associated with functional capacity and disease severity, physiotherapy becomes an important treatment resource with exercises to improve muscle strength and consequently reduce subsequent functional difficulties. However, due to the scattered evidence of physiotherapy in PD, there is insufficient evidence to prescribe a defined rehabilitation program for strengthening the trunk extensor muscles. Although there is increasing evidence of the effectiveness of land-based or aquatic therapies, the evidence is insufficient to support or refute the effectiveness of one physiotherapy intervention over another. Therefore, this study aims to describe and compare the effects of 12 weeks of land-based physical therapy and aquatic physical therapy on the motor function of individuals with PD, as well as to evaluate muscle strength, functional capacity, mobility, flexibility, muscle mass and balance, while examining the linear relationship between PD severity and these parameters. A Randomized Clinical Trial will be conducted, which will include individuals diagnosed with Parkinson's Disease, akinetic-rigid type, with postural instability, classified from 1 to 3 on the Hoehn and Yahr Scale, aged between 50 and 85 years, who sign the Free and Informed Consent Form, and have a minimum score of 26 on the Montreal Cognitive Assessment (MoCA).

Individuals will be randomized into two treatment groups: land-based physiotherapy and aquatic physiotherapy. The evaluation will be carried out in two stages: pre-intervention and post-intervention.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individuals with Parkinson's Disease to perform physiotherapy on the ground.

The protocols will last for 12 weeks, with a frequency of 2 times a week.

Group Type: ACTIVE_COMPARATOR

Aquatic physiotherapy

Intervention Type: OTHER

Aquatic physiotherapy will be performed in 12 weeks, twice a week, in shallow water. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.

Individuals with Parkinson's Disease to undergo aquatic physiotherapy

The protocols will last for 12 weeks, with a frequency of 2 times a week.

Group Type: ACTIVE_COMPARATOR

Physiotherapy on the ground

Intervention Type: OTHER

Physical therapy will be performed on the ground, in 12 weeks, twice a week. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.

Interventions

Physiotherapy on the ground

Physical therapy will be performed on the ground, in 12 weeks, twice a week. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.

Intervention Type: OTHER

Aquatic physiotherapy

Aquatic physiotherapy will be performed in 12 weeks, twice a week, in shallow water. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with Parkinson's Disease and rated from 1 to 3 on the Hoehn and Yahr Scale;
• With akinetic rigid type PD;
• Aged between 50 and 85 years old;
• Minimum score of 26 on the Montreal Cognitive Assessment (MoCA);
• Who sign the Free and Informed Consent Term (TCLE).

Exclusion Criteria

• Parkinson's disease of the dominant tremor type;
• Previous associated neurological diseases;
• Severe heart diseases;
• Uncontrolled high blood pressure;
• Previous spine surgeries;
• Inflammatory diseases of the spine;
• Chlorine allergy;
• Aquaphobia.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Cechetti

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

Função_Motora_DP+FA+FS

Identifier Type: -

Identifier Source: org_study_id