Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000268044
Ethics application status
Approved
Date submitted
24/03/2010
Date registered
1/04/2010
Date last updated
1/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the spasticity on the linear standards of gait in hemiparetic individuals
Scientific title
Effect of the spasticity on the linear standards of gait in hemiparetic individuals
Secondary ID [1] 1565 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 257022 0
Condition category
Condition code
Neurological 257180 257180 0 0
Other neurological disorders
Stroke 257181 257181 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To analyze the effect of the spasticity in the linear standards of gait in hemiparetic individuals and to correlate it with the articular largeness of the ankle. The total duration of the study lasted 1 year
Intervention code [1] 256198 0
Not applicable
Comparator / control treatment
Control group of healthy individuals between 50 and 65 years
Control group
Active

Outcomes
Primary outcome [1] 258076 0
Regarding the parameters of linear motion between the groups analyzed, the average total distance traveled (DTP) was 14.52 m for the stroke group and 32.16 m for the control group (p <0.0001) and was 23,75s in the stroke group and 19.02 in the control group (p <0.0001). To analyze these variables was used Nagasaki Protocol (1994)
Timepoint [1] 258076 0
at one year after randomisation
Primary outcome [2] 258121 0
The variables consist of linear parameters of gait, the average score for the stroke group for the average step length (SL) was 0.45, Cadence (CAD) and 1.0 speed (VEL) 0.65 m / s while in the control group had an average of 1.05 for SL, 1.03 for CAD and 1.69 m / s for VEL. Only the values of SL and VEL were statistically significant (p <0.0001), whereas CAD was not significant compared between groups (p = 0.1932). To analyze these variables was used Nagasaki Protocol (1994)
Timepoint [2] 258121 0
at one year after randomisation
Secondary outcome [1] 263658 0
Relating the degree of spasticity of the gastrocnemius muscle group of strokes with the parameters of DTP and time obtained the relationship: patients with grade 0 of spasticity had an average of 32.16 m and 19.02 s DTP time. For individuals in the group with stroke degree of spasticity of the gastrocnemius 1 DTP was 17.8 m long and 22.2 s, who had grade 2 to DTP was 16.2 m long and 26.6 for grade 3 and an average of 9m DTP and 21.47 s for the time spent on the route. To analyze the spasticity of the gastrocnemius muscle was used the Modified Ashworth Scale and parameters of linear motion, the protocol of Nagasaki (1994)
Timepoint [1] 263658 0
at one year after randomisation
Secondary outcome [2] 263770 0
Relating the degree of spasticity of the soleus muscle of both groups were obtained: average DTP 32.16 m long and 19.02 for grade 0 (control group), DTP 17.8 m and 22.86 s time to grade 1, DTP 11 , 24m and length of 24.65 s to grade 2. Relating the degree of spasticity of the gastrocnemius muscle with the spatial and temporal parameters of gait (SL, CAD and VEL) was obtained: individuals who had grade 0 the average of SL was 1.05, 1.03 CAD, VEL of 1.69 m / s, for 1 degree of spasticity, the SL was 0.56, 0.98 and CAD VEL 0.86 m / s, for grade 2 was obtained from 0.49 SL, 1.02 for CAD and 0.65 m / s VEL and patients who had grade 3 to SL was 0.29 CAD 1.01 and 0.44 VEL m / s. The relationship of the degree of spasticity of the soleus muscle with the spatial and temporal parameters of gait (SL, CAD and VEL) was analyzed and it was found: individuals who had grade 0 the average was 1.05 SL, CAD 1 , 03, VEL of 1.69 m / s, for grade 1 to SL was 0.54, the CAD of 0.99 and 0.76 VEL m / s, for grade 2 was obtained 0.36 for SL, 0 , 98 CAD and 0.48 m / s for VEL. To analyze the spasticity of the soleus muscle was used the Modified Ashworth Scale and parameters of linear motion, the protocol of Nagasaki (1994)
Timepoint [2] 263770 0
at one year after randomisation

Eligibility
Key inclusion criteria
We included individuals who had right hemiparesis and submit between 50 and 65 years of age. The control group, the individuals selected were healthy, aged 50-65 years and handed to greater reliability of the research.
Minimum age
50 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded individuals unable to walk or use any means to help or even showing any disturbance that influences the balance, vestibular and neurological disorders and deformities, unstructured, have good cognitive control and have left hemiparesis.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2557 0
Brazil
State/province [1] 2557 0

Funding & Sponsors
Funding source category [1] 256696 0
University
Name [1] 256696 0
Universidade Nove de Julho - Faculdade Marechal Rondon
Country [1] 256696 0
Brazil
Primary sponsor type
University
Name
Universidade Nove de Julho - Faculdade Marechal Rondon
Address
Vicinal Dr. Nilo Lisboa Chavasco, 5000 - Sao Manuel - SP - CEP: 18650-000
Country
Brazil
Secondary sponsor category [1] 255983 0
Individual
Name [1] 255983 0
Gustavo Luvizutto
Address [1] 255983 0
Avenida da Saudade, 225 - Sao Manuel -SP - CEP: 18650-000
Country [1] 255983 0
Brazil

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30974 0
Address 30974 0
Country 30974 0
Phone 30974 0
Fax 30974 0
Email 30974 0
Contact person for public queries
Name 14221 0
Gustavo Jose Luvizutto
Address 14221 0
Avenida da saudade - 225 - Centro - Sao Manuel/SP - CEP: 18650-000
Country 14221 0
Brazil
Phone 14221 0
+55 14-38411284
Fax 14221 0
Email 14221 0
[email protected]
Contact person for scientific queries
Name 5149 0
Gustavo Jose Luvizutto
Address 5149 0
Distrito Rubiao Junior, s/n - Botucatu/SP - CEP: 18618970
Country 5149 0
Brazil
Phone 5149 0
+55 14-38116049
Fax 5149 0
Email 5149 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.