Effectiveness of a Gait Re-education Program on a Sequential Square Treadmill (Tapiz Fisior) in Subjects With Parkison´s Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: Universidad Europea de Madrid

Gait Re-education Program in Subjects With Parkinson´s Disease 
 
NCT05131880 
 
January 31, 2021 
 
Brief Project Description (type of study, methodological design, samples or 
subjects, research variables): 
This is a randomized controlled trial including participants diagnosed with mild to 
moderate stage Parkinson’s Disease and exhibiting gait pattern alterations. Participants 
will be randomized using a simple randomization procedure. One group will receive an 
intervention based on a gait reeducation program called “TAPIZ FISIOR”—which 
combines motor control and learning with a conventional physiotherapy program. The 
other group will receive only the conventional physiotherapy program. Evaluators will 
be blinded to the treatment allocation of the patients. 
 
The project will follow the guidelines of the Declaration of Helsinki. Subject 
confidentiality will be maintained in accordance with current regulations (Organic Law 
15/1999 of December 13 on the Protection of Personal Data) and the law governing 
biomedical research (Law 14/2007 of July 3 on Biomedical Research). 
 
Description of the intervention: 
The control group will participate in a physiotherapy program commonly used for 
Parkinson’s patients (including manual therapy on a treatment table; kinesitherapy; and 
exercises for: unilateral balance with support, postural control, gait, lower limb strength, 
and spatial-somatic coordination). Three sessions per week will be conducted for 12 
weeks. 
 
The experimental group will participate in the same physiotherapy program as the 
control group, with the addition of the gait reeducation program using a sequential 
square mat (including exercises for: anterior and lateral postural control, anterior and 
lateral balance overcoming obstacles, anterior and lateral gait sequencing, and lower 
limb strength). 
 
An initial assessment will be conducted at the beginning of the study and another after 
three months. The following variables will be measured: 
 
Variables and evaluation instruments: 
 
 
For gait functional capacity, balance, and basic functional capacity: 
o Short Physical Performance Battery (SPPB, Guralnik et al., 1994): 
composed of three tests—balance (feet together, semi-tandem, tandem), 
4-meter gait speed, and chair stand test (five times). 
o Timed “Up and Go” Test (Mathias et al., 1986): designed to assess basic 
functional mobility in frail older adults. It measures the time taken to 
stand up from a chair without using arms, walk three meters, turn, return, 
and sit down again. 
o Berg Balance Scale (Berg et al., 1992): evaluates postural balance 
through 14 different items analyzing static balance. 
o MDS-UPDRS: evaluates motor status, disability level, and disease 
progression. 
 
For the quality of life variable: 
o Barthel Index: assesses the individual’s ability to perform ten basic 

activities of daily living, yielding a quantitative estimate of the subject’s 
level of dependence. 

Sample/Subjects Characteristics: 
Participants will be informed about the project and will be required to sign informed 
consent. 
 
Sample size: calculation and/or reference: 
The estimated sample size is 40 participants. This estimation is based on the results 
of the study by Valverde Guijarro et al. (2020), which investigated the effects of 
dance on balance and gait in subjects with Parkinson’s Disease and reported 
statistically significant results. 
 
Inclusion criteria: 
 
Aged over 50 years 
 
Diagnosed with Parkinson’s Disease in stages 1 to 3 of the Hoehn & Yahr 
scale (1967), i.e., mild or moderate stage 
 
Not institutionalized 
 
Able to communicate and walk at least 10 meters 
 
Barthel Index score ≥ 60 
 
No cognitive impairment, or a score ≥ 24 on the Spanish-adapted and 
validated version of the Mini-Mental State Examination (MMSE) by 
Folstein, Folstein, and McHugh (1975) 
 
Exclusion criteria: 
 
 
Medical contraindications to the treatment 
 
Severe cognitive or behavioral problems that may hinder participation in 
the training program 
 
 
 
Statistical analysis plan 
 
Frequencies and percentages were calculated for categorical variables, while means 
and standard deviations were computed for numerical variables, given their normal 
distribution according to the histogram. 
 
For the bivariate analysis, the Student’s t-test was used. Finally, linear regression 
models with robust variance were constructed to quantify the association between 
covariates according to the intervention group, considering changes in variable 
values before and after the intervention. Beta coefficients (β), standard errors, p-
values, and 95% confidence intervals were estimated.All variables were included in 
the adjusted model because they were considered confounders according to the 
reviewed literature.. The absence of collinearity was verified using the VIF 
command. 
 
All analyses were performed using Stata v.18.0 for Windows. 
 
 
 
 

INFORMED CONSENT: 
 
 
 
PATIENT INFORMATION SHEET 
 
 
STUDY TITLE: EFFECTIVENESS OF A GAIT RETRAINING PROGRAM ON A SEQUENTIAL 
SQUARES MAT IN SUBJECTS WITH PARKINSON'S DISEASE 
 
 
Dear Sir/Madam, 
 
Your physician has invited you to participate in this study. In compliance with Law 41/2002 of 
November 14th, “Basic Law regulating patient autonomy and rights and obligations regarding 
information and clinical documentation,” we now reiterate in writing the verbal explanation already 
provided, in order to request your authorization to include you in this study. 
 
Before deciding whether to participate, it is important that you understand why this study is being 
conducted and what your involvement would entail if you choose to participate. 
 
Please read the following information carefully. If there is anything unclear or if you would like more 
information, do not hesitate to ask. You may request further details from the principal investigator 
or any of their collaborators, or from your attending physician. We will allow you as much time as 
needed to make your decision. 
 
STUDY IDENTIFICATION AND DESCRIPTION 
 
This is a randomized controlled trial involving participants diagnosed with mild to moderate stage 
Parkinson’s disease who present gait pattern alterations. Participants will be randomly assigned 
using a simple randomization procedure. One group will receive an intervention based on a gait 
retraining program called “TAPIZ FISIOR,” which involves motor control learning in addition to a 
conventional physiotherapy program. The other group will receive only the conventional 
physiotherapy program. The evaluators will be blinded to the participants’ treatment group. 
 
STUDY OBJECTIVES 
 
The main aim of this study is to demonstrate the effectiveness of a structured motor control training 
sequence using a square mat to improve key gait parameters and functional capacity in individuals 
diagnosed with Parkinson’s disease. 
 
Specific objectives: 
 
- 
To demonstrate the effectiveness of a structured motor control training sequence on a square 
mat to improve gait functionality and balance in people diagnosed with Parkinson’s disease. 
 
- 
To demonstrate the effectiveness of this intervention in improving basic functional capacity in 
people with Parkinson’s disease. 
 
- 
To demonstrate the effectiveness of the square mat motor control training sequence in 
enhancing activities of daily living in this population. 
 
Participation is entirely voluntary. You are under no obligation to participate, and if you choose to 
do so, you may withdraw at any time. All aspects of this study, including results, will be handled 
with strict confidentiality. 
 
WHY HAVE YOU BEEN SELECTED? 
 
PATIENT INFORMATION SHEET 
AND INFORMED CONSENT 

You have been selected because you meet the following criteria: 
 
 
Being over 50 years of age. 
 
Being diagnosed with Parkinson’s Disease in stages 1 to 3 of the Hoehn & Yahr scale 
(1967), corresponding to mild or moderate stages. 
 
Not being institutionalized. 
 
Being able to communicate and walk at least 10 meters. A score of ≥ 60 on the 
Barthel Index. 
 
 
Not presenting cognitive impairment, or scoring ≥ 24 on the Spanish-adapted and 
validated version of the Mini-Mental State Examination (MMSE) by Folstein, Folstein, 
and McHugh (1975), known in Spain as the Mini Examen Cognoscitivo (MEC). 
 
CONFIDENTIALITY: 
 
Your right to privacy and the confidentiality of all health-related data is guaranteed, including 
both the data obtained during the research and the data recorded in your medical history. This 
is in accordance with Law 3/2018 on Personal Data Protection and guarantee of digital rights, 
and Law 41/2002 regulating patient autonomy and rights and obligations regarding clinical 
information and documentation. 
 
For the purposes of this study, you will be identified by a code, and your personal information 
will not be shared or disclosed to third parties without your prior written consent. You will not 
be personally identified in any written publications or seminars in which the results of this 
study may be presented. 
 
Monitors, auditors, the Research Ethics Committee (CEIC), and competent authorities will 
have direct access to the subject's original medical records to verify the procedures and/or 
data of the study/clinical trial, without violating subject confidentiality, as permitted by 
applicable regulations. By signing the informed consent form, the subject or their legal 
representative authorizes access to this data. 
 
ETHICAL CONSIDERATIONS: 
 
This study will be conducted in accordance with the principles of good clinical practice and is 
solely intended to demonstrate the effectiveness of a non-invasive, low-cost, and easy-to-
implement intervention aimed at improving the functional abilities of individuals with 
Parkinson’s Disease. This means that by participating in the study, you will not be subjected to 
any unnecessary procedures, nor will you be denied necessary care for your condition should 
you choose not to participate. 
 
EXPECTED DURATION OF YOUR PARTICIPATION IN THE STUDY: 
 
The study will last 12 weeks. 
 
APPROXIMATE NUMBER AND CHARACTERISTICS OF PARTICIPANTS EXPECTED TO 
BE INCLUDED IN THE STUDY: 
 
50 participants will be selected. 
 
QUESTIONS THAT MAY ARISE DURING AND AFTER YOUR PARTICIPATION IN THE 
STUDY: 
 
If you have any questions about the study at any time, you can contact: (Principal 
Investigator’s contact information) 
 
FINANCIAL COMPENSATION: 
 
There is no financial compensation for participation in this study. 
 
 

PATIENT INFORMED CONSENT 
 
 
I have read and understood the Patient Information Sheet. I have had the opportunity to 
discuss any issues related to this information. My questions and concerns have been 
answered satisfactorily. 
I understand that my participation is voluntary and that I am free to withdraw from the study at 
any time without affecting my legal rights. 
I understand that anonymized data may be used in other documents, excluding personal data, 
and will be handled with due discretion and confidentiality. 
I give authorization for my medical reports to be accessed without disclosing personal 
information. I agree that information related to my participation in this study may be shared 
with my specialist and general practitioner if requested. 
I have read the above information and I agree to participate in the study. 
 
 
 
 
PARTICIPANT 
 
Full name: .................................................................................... 
 
 
 
Signature: ____________________________ Date: _______________ 
 
LEGAL REPRESENTATIVE 
 
Full name: .................................................................................... 
 
 
 
Signature of parent, guardian, or legal representative: ____________________________ 
Date: _______________ 
 
INVESTIGATOR 
 
Full name: JOSÉ ALEGRE TAMARIZ / ALBERTO BERMEJO FRANCO 
 
 
 
Signature: ____________________________ Date: _______________

WITHDRAWAL OF PATIENT INFORMED CONSENT 
 
Mr./Ms.: .............................................................................., aged ........, residing at 
(Full name of the patient) ...................................................................................... and holder of ID 
number ........................................ 
 
 
I HEREBY WITHDRAW the consent granted on the date .........................................................., 
and I request the deletion or anonymization of all personal data and any stored samples, without 
this resulting in any harm or loss of healthcare benefits to which I am entitled. I understand that 
this deletion will not apply to data derived from consented research studies that have already 
been carried out. 
 
In Las Palmas de Gran Canaria, on the ...... day of ......................, ............ 
 
 
 
 

INFORMATION SHEET AND PERSONAL DATA CONSENT FORM 
 
In compliance with the provisions of Article 5 of Organic Law 3/2018 on the Protection of 
Personal Data and the Guarantee of Digital Rights, which regulates the right to information in 
the collection of data, we inform you that the personal data provided in this form will be included 
in and treated with confidentiality and security in files under the responsibility of THE GENERAL 
MANAGEMENT 
OF 
….............................................................................................................................., the purpose 
of which is to carry out A RESEARCH STUDY making use of new technologies. 
 
The recipient of the data is THE RESEARCH TEAM OF THE SERVICE (indicate name of the 
Service), WITH THE PRINCIPAL INVESTIGATOR (indicate name(s) of the principal 
investigator(s)) BEING RESPONSIBLE, and there is no intention to transfer data to third parties 
other than those provided for by law or those expressly authorized by you or your legal 
representative. Likewise, the Collaborating Investigators (indicate name(s) of the collaborating 
investigator(s)) shall also assume this responsibility. 
 
The data provided must be truthful, accurate, complete, and up to date. The participant will be 
responsible for any direct or indirect damage or harm resulting from failure to comply with this 
obligation. 
 
In compliance with the principle of data quality, the GENERAL MANAGEMENT OF 
…............................................................................................................................................. will 
retain the information recorded for the purpose described. If you wish to modify your data, you 
must contact the principal investigator. 
 
The participant may exercise the rights of access, rectification, cancellation, and opposition 
under the terms established in the aforementioned Organic Law 3/2018 and related regulations 
before the GENERAL MANAGEMENT OF ................................................................................., 
located at ............................................................................................................................... 
 
You may revoke the consent granted, without retroactive effect, by submitting a written request 
to the GENERAL REGISTRY of ……………………………, expressly mentioning “Data 
Protection”, or by email to the following address (email of the principal investigator(s); either 
provide a corporate email address or create one exclusively for the study), or by ordinary mail to 
the above-mentioned address, enclosing a copy of your National ID Card (DNI). 
 
 
PARTICIPANT 
 
Full Name: .................................................................................... 
 
 
 
Signature: _____________________________ Date: _______________ 
 
LEGAL REPRESENTATIVE 
 
Full Name: .................................................................................... 
 
 
 
Signature of parent/guardian: _____________________________ Date: _______________ 
 
INVESTIGATOR 
 
Full Name: .................................................................................... 
 
 
 
Signature: _____________________________ Date: _______________