Manual Therapy in Parkinson's Disease

NCT06853262 | Active Not Recruiting

• 1 other identifier: CHUC_2024_28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Autonomic nervous system activity

  To evaluate the activity of the ANS through the indices of the Sympathetic Nervous System (SNS) and Parasympathetic Nervous System (PNS). These two parameters are the main variables of the study and were evaluated before, during and after the manual protocols to be applied. For this purpose, the Elite HRV smartphone application was used, which connects to a Polar transmitter band placed on the person's chest at the level of the xiphoid process of the sternum, which allowed constant monitoring of the subject during each of the interventions.

  Baseline and every six weeks for up to 6 months from the start

Secondary Outcomes (7)

• PD NMS Quest

  Baseline and every six weeks for up to 6 months from the start

• Mini-BESTest

  Baseline and every six weeks for up to 6 months from the start

• Berg Balance Scale

  Baseline and every six weeks for up to 6 months from the start

• Timed Up and Go (TUG)

  Baseline and every six weeks for up to 6 months from the start

• Tinetti scale

  Baseline and every six weeks for up to 6 months from the start

Study Arms (2)

Manual Therapy Protocol

EXPERIMENTAL

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.

Other: Manual Therapy Protocol

Sham Manual Protocol

SHAM COMPARATOR

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

Other: Sham Manual Protocol

Interventions

Manual Therapy Protocol 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.

Manual Therapy Protocol

Sham Manual Protocol 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.

Sham Manual Protocol

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of La Laguna: lead

Study Sites (1)

Facultad de Ciencias de la Salud

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38200, Spain

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Clinical Professor; Head of the Clinical Research Laboratory - Physiotherapy Department

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 28, 2025
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)