Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06853262

Manual Therapy in Parkinson's Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Ciencias de la Salud

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Autonomic nervous system activity

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

    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.

Secondary outcomes

  1. PD NMS Quest

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

    PD NMS Quest: this is the questionnaire for non-motor symptoms in Parkinson's disease. It consists of 30 yes or no questions.

  2. Mini-BESTest

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

    Mini-BESTest: identified as the most comprehensive balance measurement for adults and the elderly. It has a series of items with their corresponding score, the maximum score that can be obtained at the end of the test is 28 points.

  3. Berg Balance Scale

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

    Berg Balance Scale: allows the static and dynamic balance abilities of a person to be assessed. Like other tests and scales, it has a series of items and the maximum score that can be achieved at the end of the test is 56 points.

  4. Timed Up and Go (TUG)

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

    Timed Up and Go (TUG): this is a test that consists of getting up from a chair, walking to a mark 3 metres away, turning around and sitting back down in the same chair. The time taken to complete the test is measured.

  5. Tinetti scale

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

    Tinetti scale: used to detect the risk of falls in the elderly, it consists of a series of items with their corresponding score. The maximum score that can be obtained at the end of the test is 28 points.

  6. Range of Motion (ROMs)

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

    Range of Motion (ROMs): using slow-motion recordings from a sagittal plane, the ranges of hip, knee, plantar and dorsal ankle flexion are measured while the person walks in a straight line. The recordings are then imported into software where the corresponding analyses of the captured images are carried out. The results are expressed in degrees.

  7. Walk Measure

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

    Stride length: the distance between the points of contact of the alternating feet with the ground. To evaluate this variable, the same process is used as for the ROMs (using slow-motion videos and subsequent analysis). The results are expressed in centimetres (cm).

    Bipodal support time: this is the time that both feet are supported on the ground while walking. To evaluate this variable, the same process was carried out as with the ROMs and the length of the step (using slow motion videos and subsequent analysis). The results are expressed in milliseconds (ms).

    Stride time: this is the time interval between two successive contacts of the same foot on the ground. To evaluate this variable, the same process is used as for ROMs, stride length and bipodal support time (using slow motion videos and subsequent analysis). The results are expressed in milliseconds (ms).

Sponsors and collaborators

Lead sponsor

University of La Laguna

Other

Registry information

Official study title

Influence of Manual Therapy on the Motor and Non-motor Symptoms of Parkinson's Disease

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.