Parkinson Disease
Conditions
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.
Interventions
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.
OTHERSham 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.
Sponsors
University of La Laguna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic nervous system activity | 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
| Measure | Time frame | Description |
|---|---|---|
| PD NMS Quest | 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. |
| Mini-BESTest | 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. |
| Berg Balance Scale | 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. |
| Timed Up and Go (TUG) | 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. |
| Tinetti scale | 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. |
| Range of Motion (ROMs) | 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. |
| Walk Measure | 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). |
Countries
Spain
Outcome results
None listed