Parkinson DiseaseNCT06853262
Manual Therapy in Parkinson's Disease
A study testing Manual Therapy Protocol in people with Parkinson Disease, run by University of La Laguna at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Manual Therapy Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People aged between 40 and 75 who voluntarily agree to take part in this study
Who cannot join
- People with Dementia and established cognitive impairment with scores on the Montreal Cognitive Assessment Test (MoCA) of less than 25
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Ciencias de la Salud
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38200
About this study
Official title: Influence of Manual Therapy on the Motor and Non-motor Symptoms of 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.
- Conditions
- Parkinson Disease
- Being tested
- Manual Therapy Protocol, Sham Manual Protocol
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy ProtocolOther
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Sham Manual Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and every six weeks for up to 6 months from the start
Secondary outcomes (7)
PD NMS Quest
PD NMS Quest: this is the questionnaire for non-motor symptoms in Parkinson's disease. It consists of 30 yes or no questions.
Measured: Baseline and every six weeks for up to 6 months from the start
Mini-BESTest
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.
Measured: Baseline and every six weeks for up to 6 months from the start
Berg Balance Scale
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.
Measured: Baseline and every six weeks for up to 6 months from the start
Timed Up and Go (TUG)
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.
Measured: Baseline and every six weeks for up to 6 months from the start
Tinetti scale
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.
Measured: Baseline and every six weeks for up to 6 months from the start
Range of Motion (ROMs)
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.
Measured: Baseline and every six weeks for up to 6 months from the start
Walk Measure
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).
Measured: Baseline and every six weeks for up to 6 months from the start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Elicio Hernández Xumet, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853262
- Sponsor's protocol ID
- CHUC_2024_28
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Manual Therapy on the Motor and Non-motor Symptoms of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06853262
- Acronym / sponsor ID
- CHUC_2024_28
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Protocol | Experimental | Other: Manual Therapy ProtocolThe 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. |
| Sham Manual Protocol | Sham comparator | Other: Sham Manual ProtocolManual intervention protocol with placebo techniques where the hands are placed on the same areas as in the experimental protocol techniques |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People aged between 40 and 75 who voluntarily agree to take part in this study
Key exclusion criteria (1 listed)
- People with Dementia and established cognitive impairment with scores on the Montreal Cognitive Assessment Test (MoCA) of less than 25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy ProtocolThe 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. | Other | Manual Therapy Protocol |
| Sham Manual ProtocolThe 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. | Other | Sham Manual Protocol |
Primary outcome
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.
7 secondary outcomes
PD NMS Quest
Time frame: Baseline and every six weeks for up to 6 months from the start
Mini-BESTest
Time frame: Baseline and every six weeks for up to 6 months from the start
Berg Balance Scale
Time frame: Baseline and every six weeks for up to 6 months from the start
Timed Up and Go (TUG)
Time frame: Baseline and every six weeks for up to 6 months from the start
Tinetti scale
Time frame: Baseline and every six weeks for up to 6 months from the start
Range of Motion (ROMs)
Time frame: Baseline and every six weeks for up to 6 months from the start
Walk Measure
Time frame: Baseline and every six weeks for up to 6 months from the start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy Protocol in people with Parkinson Disease, run by University of La Laguna at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic nervous system activity (time frame: Baseline and every six weeks for up to 6 months from the start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.