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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of Transcutaneous Electrical Stimulation in gait of people with Parkinson's Disease
Scientific title
Study of Transcutaneous Electrical Stimulation in gait parameters of people with Parkinson's Disease
Secondary ID [1] 252974 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 258473 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258639 258639 0 0
Neurological 258662 258662 0 0

Study type
Description of intervention(s) / exposure
Before the aplication of stimulation in both groups, we applied a anamnese questionnaire with inclusion criterias of the study and personal informations such age, gender, ocupation, escolarity and time of diagnostic. If the person was able to participate of the study, the Hoehn-Yahr Modified scale was applied for classify the people in different stages of Parkinson's disease. Transcutaneous Electrical Stimulation on posterior cervical region, c3-c5 segments at Tens mode, small electrode of 1 cm by 0,5 cm, frequency=250 hz, pulse width=300 ms and intensity regulated at the maximum value possible, but respecting the people's perception. This procedure was a single procedure and had a half hour of duration.
Intervention code [1] 257469 0
Treatment: Devices
Comparator / control treatment
In control group, the Transcutaneous Electrical Stimulation device was used on posterior cervical region, c3-c5 segments, but the device was on (with same parameters of intervention group) with intensity zero. Therefore, the people in control group did not receive the stimulation.
Control group

Primary outcome [1] 259482 0
Gait parameters such step lenght, stride lenght and base width was obtained through the Footprint method of gait assessment. This method consists in a paper walkway. We printed a device placed at people's heel and they walk on the paper walkway. This form, we obtained the value of the variables above (gait parameters). Beyond this, the gait velocity was evaluated through the formula velocity=distance/time. The time was obtained through a chronometer.
Timepoint [1] 259482 0
The gait parameters were evaluated before and after the Transcutaneous Electrical Stimulation in a single session.
Primary outcome [2] 259523 0
The generality motor standard of people was evaluated too by Unified Parkinson's Disease Rating Scale Motor Exam
Timepoint [2] 259523 0
The Unified Parkinson's Disease Rating Scale Motor Exam's scores were evaluated before and after the Transcutaneous Electrical Stimulation in a single session.
Secondary outcome [1] 266133 0
Timepoint [1] 266133 0

Key inclusion criteria
The people were included in the study if they have a physician diagnostic of Parkinson's disease and if they were associated at Instituto Parkinsoniano de Minas Gerais, located at Timoteo city, Minas Gerais, Brazil.
Minimum age
52 Years
Maximum age
77 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
The people were excluded of the study if they have serious cardiorrespiratory or cardiovascular diseases, pathologic joint conditions and incapacity musculoskeletal diseases, another nervous system disease and people classified at estage five of Hoehn Yahr Modified scale.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The people were allocated in two groups: intervention and control through a central randomization by computer (computer software). The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. The intervention group has nine participants and the control group have eight participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used for allocate the participants was simple randomization using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 2987 0
State/province [1] 2987 0

Funding & Sponsors
Funding source category [1] 257921 0
Name [1] 257921 0
Instituto Parkinsoniano de Minas Gerais (Gruparkinson)
Address [1] 257921 0
Avenida 13, 70, Bairro Santa Maria - Timoteo - Minas Gerais - Cep 35.180-144
Country [1] 257921 0
Primary sponsor type
Ronaldo Araujo Abreu
Avenida Luiz Ramires, 341 - Recanto - Timoteo, Minas Gerais - CEP 35.182-400
Secondary sponsor category [1] 257111 0
Name [1] 257111 0
Lucas Araujo Castro e Souza
Address [1] 257111 0
Avenida Joao Pinheiro, 213 - Centro - Itabira, Minas Gerais. Cep 35.900-538
Country [1] 257111 0
Secondary sponsor category [2] 257112 0
Name [2] 257112 0
Edmar Henrique Ribeiro
Address [2] 257112 0
Rua Quincas Custodio, 10 - Bairro Areao - Itabira, Minas Gerais - CEP 35.900-397
Country [2] 257112 0
Secondary sponsor category [3] 257131 0
Name [3] 257131 0
Paula Maria Machado Arantes
Address [3] 257131 0
Rua Muzambinho, 159 - Bairro Cruzeiro, Belo Horizonte - Minas Gerais - CEP 30.310-280
Country [3] 257131 0
Other collaborator category [1] 251622 0
Name [1] 251622 0
Lucas Henrique Maia Magalhaes
Address [1] 251622 0
Rua Mariana, 120 - Centro - Ipatinga - Minas Gerais - Cep 35.160-018
Country [1] 251622 0
Other collaborator category [2] 251624 0
Name [2] 251624 0
Address [2] 251624 0
Rua Venancio Augusto Gomes, 50 - Predio Areao - Bairro Major Lage de Cima - Cep: 35900-842 - Itabira - Minas Gerais
Country [2] 251624 0

Ethics approval
Ethics application status
Ethics committee name [1] 259935 0
Comite de Etica da Santa Casa de Misericordia
Ethics committee address [1] 259935 0
Avenida Francisco Sales, 1111 - Santa Efigenia, Belo Horizonte - Cep 30150-221
Ethics committee country [1] 259935 0
Date submitted for ethics approval [1] 259935 0
Approval date [1] 259935 0
Ethics approval number [1] 259935 0

Brief summary
The purpose of the study was to evaluate if the Transcutaneous Electrical Stimulation applied at posterior cervical region segments c3-c5 has an effect in standard motor of Parkinson's disease patients.
Trial website
Trial related presentations / publications
The abstract of the pilot study of our study, with seven patients, was published in Annals of 17th Brazilian Congress of Geriatrics and Gerontology. Complete reference: ABREU, R. A. ; SOUZA, L. A. C. ; RIBEIRO, E. H. ; ARANTES, P. M. M. ; MAGALHAES, L. H. M. Estudo da Estimulação Elétrica Transcutânea na marcha de indivíduos com Doença de Parkinson. In: XVII Congresso Brasileiro de Geriatria e Gerontologia, 2010, Belo Horizonte. Anais do XVII Congresso Brasileiro de Geriatria e Gerontologia, 2010. v. 1. p. 00-00.
Public notes

Principal investigator
Name 31824 0
Address 31824 0
Country 31824 0
Phone 31824 0
Fax 31824 0
Email 31824 0
Contact person for public queries
Name 15071 0
Ronaldo Araujo Abreu
Address 15071 0
Avenida Luiz Ramires, 341 - Bairro Recanto - Timoteo, Minas Gerais - Cep 35.182-400
Country 15071 0
Phone 15071 0
+55 (31) 9611-8066
Fax 15071 0
Email 15071 0
Contact person for scientific queries
Name 5999 0
Ronaldo Araujo Abreu
Address 5999 0
Avenida Luiz Ramires, 341 - Bairro Recanto - Timoteo, Minas Gerais - Cep 35.182-400
Country 5999 0
Phone 5999 0
+55 (31) 9611-8066
Fax 5999 0
Email 5999 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary