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Trial registered on ANZCTR


Registration number
ACTRN12610000922077
Ethics application status
Approved
Date submitted
23/10/2010
Date registered
29/10/2010
Date last updated
29/10/2010
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
None
Universal Trial Number (UTN)
U1111-1117-5688
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
Physiotherapy
Neurological 258662 258662 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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
None
Timepoint [1] 266133 0
None

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 257921 0
Charities/Societies/Foundations
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
Brazil
Primary sponsor type
Individual
Name
Ronaldo Araujo Abreu
Address
Avenida Luiz Ramires, 341 - Recanto - Timoteo, Minas Gerais - CEP 35.182-400
Country
Brazil
Secondary sponsor category [1] 257111 0
Individual
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
Brazil
Secondary sponsor category [2] 257112 0
Individual
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
Brazil
Secondary sponsor category [3] 257131 0
Individual
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
Brazil
Other collaborator category [1] 251622 0
Individual
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
Brazil
Other collaborator category [2] 251624 0
University
Name [2] 251624 0
Funcesi
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
Brazil

Ethics approval
Ethics application status
Approved
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
Brazil
Date submitted for ethics approval [1] 259935 0
18/12/2009
Approval date [1] 259935 0
05/02/2010
Ethics approval number [1] 259935 0
122/2009

Summary
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

Contacts
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
Brazil
Phone 15071 0
+55 (31) 9611-8066
Fax 15071 0
Email 15071 0
ronaldoabreu.abreu@gmail.com
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
Brazil
Phone 5999 0
+55 (31) 9611-8066
Fax 5999 0
Email 5999 0
ronaldoabreu.abreu@gmail.com

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