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

NCT05866120 | Completed DMC

• 1 other identifier: Função_Motora_DP+FA+FS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Physical Therapy Modalities; Muscle Strength; Aquatic Therapy

Outcome Measures

Primary Outcomes (9)

• MDS UPDRS Motor Assessment

  The Unified Parkinson's Disease Rating Scale (UPDRS) is a tool used to monitor the progression of the disease. Part II of the scale is the patient's self-assessment of daily activities, while part III is the motor assessment monitored by the clinician. Part II of the UPDRS assesses: speech, swallowing, writing, dressing, hygiene, falls, salivation, turning over in bed, walking, and cutting food. Part III of the UPDRS is the motor assessment monitored by clinical aspects and the cutoff points for classifying motor impairment as mild, moderate, and severe are as follows: Mild/Moderate - 32/33, Moderate/Severe - 58/59.

  3 months

• Berg Scale and Romberg Test

  The Berg Balance Scale (BBS), translated and validated into Brazilian Portuguese in 2004, will be used to assess postural balance. The BBS, developed in 1992, consists of 14 common tasks involving static and dynamic balance. The tasks are evaluated through observation, presenting an ordinal scale of five alternatives, ranging from zero to four, totaling a maximum score of 56 points. The score decreases if the time to perform the task is not reached, or the individual needs supervision or external support to perform it. The Romberg test, on the other hand, consists of a clinical evaluation that reveals alterations in the patient's static balance, allowing the analysis of 3 neurophysiological bases that make balance possible: vestibular, visual and proprioceptive systems. This test exists to investigate disturbances that interfere with this task. A positive Romberg can be seen with loss of balance during the procedure.

  3 months

• Timed Up and Go (TUG)

  The Timed Up and Go (TUG) test will also be used, which was developed to assess balance, risk of falls and functional capacity of elderly individuals, timing the time it takes the individual to leave the sitting position with the back supported on a chair, stand up, walk 3 meters to a marked point on the ground as fast as possible, turn around, return to the chair and sit down again, leaning against it. Performance is evaluated according to the time taken to perform the task. It takes approximately 1 to 2 minutes and only requires a chair approximately 46cm high and 65cm high armrest, a stopwatch and a 3 meter runner. The patient will perform the test a first time to understand the task and a second time for registration and evaluation. A time greater than 30 seconds to perform the task is indicative of the individual's functional dependence.

  3 months

• Dual-energy X-ray absorptiometry

  Whole-body dual-energy X-ray absorptiometry (DEXA) is a sensitive and accurate method for quantifying body composition, including fat mass and lean body mass as a surrogate measure of skeletal muscle. Body composition will be estimated by dual-energy X-ray absorptiometry. Prior to scanning, participants will be asked to remove all removable objects containing metal (i.e. jewelry, glasses, clothing with buttons and/or zippers). Scans will be performed with participants lying supine along the longitudinal axis of the centerline of the scanning table. The feet will be tied together to immobilize the legs, while the hands will be kept in a prone position within the scanning region. All exams will be performed by the same evaluator. DEXA results will include body composition parameters including fat free mass, body fat percentage, fat mass and bone mineral density (whole body, whole left femur and lumbar spine vertebrae).

  3 months

• Ultrasonography

  Ultrasonography is a non-invasive method for assessing the thickness and echogenicity of skeletal muscle. The research subjects will be approved to evaluate the quadriceps femoris musculature through Ultrasonography Nemio XG (Toshiba, Japan) in B mode and a 3.75 MHz convex transducer. The transducer will be coated with a water-soluble transmission gel to provide acoustic contact without depressing the dermal surface.

  3 months

• Isokinetic dynamometer - torque

  The isokinetic dynamometer is considered the gold standard instrument for assessing muscle performance, whether to analyze the effectiveness of training, treatment or even to verify a person's muscle condition. The individuals will be submitted to an isokinetic muscular evaluation of the trunk extensor and flexor muscles and knee extensors and flexor performed in a Cybex Norm isokinetic dynamometer (Cybex Inc., Ronkonkoma, NY, USA).

  3 months

• Parkinson's Disease Questionnaire (PDQ-39)

  The PDQ-39 will be applied to assess the patient's perception of quality of life, participation and restrictions resulting from the disease. The PDQ-39 is the most used disease-specific quality of life assessment tool in PD. The questionnaire consists of 39 questions covering the themes: mobility, activities of daily living, emotional well-being, social support, bodily discomfort, stigma, cognition and communication. The individual identifies how often in the last month he found himself in the situations mentioned. The options are never (0 points), rarely (1 point), sometimes (2 points), often (3 points), and always (4 points). Between 0 and 100, the lowest score corresponds to the highest quality of life.

  3 months

• Sit-and-Reach test

  Muscle flexibility will be assessed by the Sit-and-Reach (SR) test, in which the patient, sitting with legs extended and feet resting on a box, leans forward keeping arms extended and knees straight. The greatest distance reached will be recorded in centimeters (cm).

  3 months

• 30-second sit-to-stand test

  The 30-second sit-to-stand test (STS) assesses functional capacity by recording the number of repetitions completed within a set time. Participants will begin by sitting in a 17-inch-high chair with their arms crossed in front of their chest and perform the sit-to-stand cycles as quickly as possible. They will be instructed to stand fully upright and to touch the seat each time they sit down again.

  3 months

Secondary Outcomes (1)

• Thigh and quadriceps muscle quality by specific tension and echo intensity

  3 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Other: Aquatic physiotherapy

Individuals with Parkinson's Disease to undergo aquatic physiotherapy

ACTIVE COMPARATOR

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

Other: Physiotherapy on the ground

Interventions

Physiotherapy on the ground 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.

Individuals with Parkinson's Disease to undergo aquatic physiotherapy

Aquatic physiotherapy 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 perform physiotherapy on the ground.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Universidade de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: May 19, 2023
• Study Start: June 12, 2023
• Primary Completion: April 15, 2024
• Study Completion: December 15, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)