Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001092088
Ethics application status
Approved
Date submitted
6/12/2010
Date registered
13/12/2010
Date last updated
13/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electric stimulation and walking backwards on a treadmill: the effect of a training day on locomotor pattern in individuals following stroke.
Scientific title
Electric stimulation and walking backwards on a treadmill: the effect of a training day on locomotor pattern in individuals following stroke.
Secondary ID [1] 253244 0
The participants agreed with the Informed Consent approved by the Ethics in Human Research - CEP Universidade do Estado de Santa Catarina Brazil protocol number 43/2009.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The decrease in knee flexion in swing phase present in chronic stroke individuals 258774 0
Condition category
Condition code
Stroke 258917 258917 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Backward walking performed for 20 minutes on the treadmill at comfortable speed supervised by a physiotherapist associated with electric stimulation in the knee flexors in the swing phase triggered by a sensor placed on the insole. The subjects with chronic hemiparesis were filmed while walking on a treadmill in three conditions in the Bacward Walking ( before training, During the ride back with electric stimulation and 10 minutes after training ) and two conditions of Forwad Walking (pre-trainig and after the training)
Intervention code [1] 257711 0
Rehabilitation
Comparator / control treatment
Backward and foward walking on the treadmill at comfortable speed with no electric stimulation supervised by a physiotherapist. The patients are their own controls
Control group
Active

Outcomes
Primary outcome [1] 259783 0
Angular variables of knee analyzed with Kinematics
Timepoint [1] 259783 0
measured before and after backward and foward walking
Primary outcome [2] 259784 0
Intra limb coordination through the method called vector coding
Timepoint [2] 259784 0
measured before and after foward walking
Secondary outcome [1] 268561 0
Angular variables of hip analyzed with Kinematics
Timepoint [1] 268561 0
measured before and after backward and foward walking

Eligibility
Key inclusion criteria
Chronic Stroke (at least six months), Medical Release for physical activity, Level 4 and 5 of the Functional Ambulation Category
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Thomas test positive greater than 15 degrees, residual flexion deformity of the knees or limitation greater than 30 degrees for knee flexion with hip extension, Tonus of knee extensors greater than 2 in the modified Ashworth scale, Another diagnosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 3076 0
Brazil
State/province [1] 3076 0

Funding & Sponsors
Funding source category [1] 258176 0
University
Name [1] 258176 0
Universidade do Estado de Santa Catarina
Country [1] 258176 0
Brazil
Primary sponsor type
Individual
Name
Natalia Duarte Pereira
Address
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country
Brazil
Secondary sponsor category [1] 257351 0
Individual
Name [1] 257351 0
Stella Maris Michaelsen
Address [1] 257351 0
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country [1] 257351 0
Brazil
Other collaborator category [1] 251718 0
Individual
Name [1] 251718 0
Angelica Cristiane Ovando
Address [1] 251718 0
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country [1] 251718 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31992 0
Address 31992 0
Country 31992 0
Phone 31992 0
Fax 31992 0
Email 31992 0
Contact person for public queries
Name 15239 0
Natalia Duarte Pereira
Address 15239 0
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 15239 0
Brazil
Phone 15239 0
55 11 8114 8153
Fax 15239 0
Email 15239 0
[email protected]
Contact person for scientific queries
Name 6167 0
Stella Maris Michaelsen
Address 6167 0
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 6167 0
Brazil
Phone 6167 0
55 11 8114 8153
Fax 6167 0
Email 6167 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.