Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000377033
Ethics application status
Approved
Date submitted
3/05/2010
Date registered
11/05/2010
Date last updated
11/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hemiparetic Gait: A Comparison Between Overground And Treadmill
Scientific title
After 15 minutes of treadmill walking patients with hemiparesis showed equivalence in most of the spatial-temporal and angular variables during overground walking
Secondary ID [1] 251672 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiparetic gait 257272 0
Condition category
Condition code
Neurological 257420 257420 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evaluation of kinematic of the hemiparetic lower limb and apatial-temporal data of hemiparetic gait overground and on the treadmill with the same speed. The overground walking data was obtained first of all with patients walking on a 8-m long walkway. Then was assessed the treadmill walking during 15 minutes, wich was subdivided into three 5-minute collections. A three-minute rest period was allowed between each collection. The images on the treadmill condition were captured at the 4th minute of each collection.
Intervention code [1] 256391 0
Not applicable
Comparator / control treatment
All participants take part in the overground and treadmill walking. The overground walking data act as the comparator treatment of the results obtained at the three 5-minutes collections on the treadmill walking.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258338 0
There were alterations in some of the spatio-temporal characteristics on the treadmill walking compared to overground walking registered by the Motion Capture System (Qualisys AB). Cadence increased 3,8%, stride lenght and paretic limb step time decreased 5% and 4,9% respectively.
Timepoint [1] 258338 0
After 5 minutes of treadmill walking.
Primary outcome [2] 258339 0
There were alterations in some of the Kinematic characteristics on the treadmill walking compared to overground walking registered by the Motion Capture System (Qualisys AB).There were a increase of 26.8% in knee angle at initial contact, 9.7% and 14.3% in hip and knee amplitude respectively. There were a decrease of 61.4% in maximum knee stance extension and 24% in maximum ankle dorsiflexion in the stance fase.
Timepoint [2] 258339 0
After 5 minutes of treadmill walking.
Primary outcome [3] 258340 0
Hip amplitude, knee angle at initial contact and maximum knee stance extension were not significantly altered on the treadmill walking compared to overground walking registered by the Motion Capture System (Qualisys AB).
Timepoint [3] 258340 0
After 15 minutes of treadmill walking.
Secondary outcome [1] 264056 0
There were increases of 3.6% in cadence and 14% in knee amplitude on the treadmill walking compared to overground walking registered by the Motion Capture System (Qualisys AB). There were decreases of 5% in stride lenght, 6,1% in paretic limb step time and 27,3% in maximum dorsiflexion on the treadmill walking compared to overground walking registered by the Motion Capture System (Qualisys AB).
Timepoint [1] 264056 0
After 15 minutes of treadmill walking.

Eligibility
Key inclusion criteria
Hemiparesis resulting from a single ischemic or hemorrhagic stroke event; lesion time of more than 6 months; levels 1 and 2 on the modified Ashworth Scale for the paretic lower limb; Functional Ambulatory Category 3 -5; absence of clinical signs of cardiac alterations, arrhythmia or angina (New York Heart Association degree I); and little or no treadmill experience.
Minimum age
39 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to complete 15 minutes of treadmill walking due to phobia, for exceeding 75% of maximum cardiac frequency or for increasing 10mmHg in the sistolic arterial pressure of the beginning of the evaluation.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
The subjects underwent to one day of assessment for the following procedures: overground walking and treadmill walking.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2607 0
Brazil
State/province [1] 2607 0
Natal, Rio Grande do Norte.

Funding & Sponsors
Funding source category [1] 256896 0
Government body
Name [1] 256896 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico
Country [1] 256896 0
Brazil
Primary sponsor type
University
Name
Federal University of Rio Grande do Norte
Address
Av. Senador Salgado Filho, 3000 Caixa Postal 1524 - CEP:59072-970 Natal - Rio Grande do Norte
Country
Brazil
Secondary sponsor category [1] 256167 0
None
Name [1] 256167 0
Address [1] 256167 0
Country [1] 256167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258906 0
Research Ethics Committee of the Federal University of Rio Grande do Norte
Ethics committee address [1] 258906 0
Ethics committee country [1] 258906 0
Brazil
Date submitted for ethics approval [1] 258906 0
Approval date [1] 258906 0
17/10/2008
Ethics approval number [1] 258906 0
266/2008

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

Contacts
Principal investigator
Name 31113 0
Address 31113 0
Country 31113 0
Phone 31113 0
Fax 31113 0
Email 31113 0
Contact person for public queries
Name 14360 0
Ana Raquel Rodrigues Lindquist
Address 14360 0
Universidade Federal do Rio Grande do Norte - UFRN Departamento de Fisioterapia Centro de Ciencias da Saude Av. Senador Salgado Filho, 3000, Natal-RN Caixa Postal 1524 - CEP:59072-970
Country 14360 0
Brazil
Phone 14360 0
55 84 3342 2010
Fax 14360 0
55 84 3342 2000
Email 14360 0
[email protected]
Contact person for scientific queries
Name 5288 0
Luciana de Andrade Mendes
Address 5288 0
R. Souza Machado, 1030, Tirol, Natal - RN
CEP 59015-080
Country 5288 0
Brazil
Phone 5288 0
55 84 9928 1101
Fax 5288 0
Email 5288 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.