Manual Therapy in Parkinson's Disease

NCT ID: NCT06853262

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-12-31

Brief Summary

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An experimental study will be carried out to examine how a manual therapy protocol can influence a series of parameters related to motor and non-motor symptoms in patients who have Parkinson's disease / Parkinsonism.

To do this, an intervention will be carried out that will last a minimum of 6 weeks. In addition to their ongoing treatment, the study subjects will receive a maximum of 2 sessions of manual therapy each week. They will undergo a series of measurements both before and after the intervention related to gait, balance, non-motor symptoms, and some more specific parameters of gait.

The study's main objective is to obtain information about possible treatment models based on manual therapy for Parkinson's disease. It is also hoped to compile a series of results that will lead to conclusions and benefit the development of physiotherapy for this disease. It is also hoped that this will help those affected so that the treatment is as comprehensive as possible and that the physiotherapist can use as many tools as are available to them to address the pathology.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Manual Therapy Protocol

The study subjects will receive a maximum of two manual therapy sessions per week for a minimum of six weeks. The variables will be measured before and after the six weeks for the secondary variables and during all the sessions for the main variables of nervous system activity.

The intervention protocol consists of a maximum of 15 manual therapy techniques, which will always be carried out in the same order. The estimated time for each technique is 90 seconds. Therefore, the intervention protocol will last approximately 25-35 minutes.

Before starting treatment, the patient will receive a document with all the information regarding the study and the informed consent form, which the research team must fill out and sign before the intervention.

Group Type EXPERIMENTAL

Manual Therapy Protocol

Intervention Type OTHER

The techniques were divided into three main groups: first, those carried out in transverse planes, then carried out in a specific zone, and finally, those aimed at the course of the vagus nerve. The techniques are carried out by physiotherapists with more than 15 years of healthcare experience and trained in manual therapy with more than 10 years of experience in this field.

Sham Manual Protocol

Manual intervention protocol with placebo techniques where the hands are placed on the same areas as in the experimental protocol techniques

Group Type SHAM_COMPARATOR

Sham Manual Protocol

Intervention Type OTHER

The Sham techniques were divided into three main groups: first, those carried out in transverse planes, then carried out in a specific zone, and finally, those aimed at the course of the vagus nerve. The Sham techniques are carried out by physiotherapists with more than 15 years of healthcare experience and trained in manual therapy with more than 10 years of experience in this field.

Interventions

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Manual Therapy Protocol

The techniques were divided into three main groups: first, those carried out in transverse planes, then carried out in a specific zone, and finally, those aimed at the course of the vagus nerve. The techniques are carried out by physiotherapists with more than 15 years of healthcare experience and trained in manual therapy with more than 10 years of experience in this field.

Intervention Type OTHER

Sham Manual Protocol

The Sham techniques were divided into three main groups: first, those carried out in transverse planes, then carried out in a specific zone, and finally, those aimed at the course of the vagus nerve. The Sham techniques are carried out by physiotherapists with more than 15 years of healthcare experience and trained in manual therapy with more than 10 years of experience in this field.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* People aged between 40 and 75 who voluntarily agree to take part in this study

Exclusion Criteria

* People with Dementia and established cognitive impairment with scores on the Montreal Cognitive Assessment Test (MoCA) of less than 25
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of La Laguna

OTHER

Sponsor Role lead

Responsible Party

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Juan Elicio Hernández Xumet

Principal Investigator; Clinical Professor; Head of the Clinical Research Laboratory - Physiotherapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Facultad de Ciencias de la Salud

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan-Elicio Hernández-Xumet, PhD

Role: CONTACT

Phone: 0034922319435

Email: [email protected]

Facility Contacts

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Juan-Elicio Hernández-Xumet, PhD

Role: primary

Other Identifiers

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CHUC_2024_28

Identifier Type: -

Identifier Source: org_study_id