Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000429055
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
26/05/2010
Date last updated
26/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Treadmill Inclination on the Gait of Individuals with Chronic Hemiparesis
Scientific title
Effect of treadmill inclination on angular alterations, amplitude of hip and knee movement, and stance time of the paretic lower limb in individuals with chronic hemiparesis resulting from a single ischemic or hemorrhagic stroke event
Secondary ID [1] 251772 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiparetic gait 257366 0
Stroke 257437 0
Condition category
Condition code
Neurological 257511 257511 0 0
Other neurological disorders
Stroke 257585 257585 0 0
Ischaemic
Stroke 257586 257586 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The subjects were assessed for functional independence (Measure of Functional Independence) and balance (Berg Balance Scale). Spatial-temporal variables of the hemiparetic lower limb were observed as well as the angular variation of the hip, knee and ankle in the sagittal plane while the individuals walked on the treadmill at three different inclinations (0%, 5% and 10%) during 2 minutes in each condition. The treadmill was then turned on and the speed gradually increased until it reached the velocity calculated during the 10-meter test. After two minutes, a 30-second capture was made (dynamic collection). All the individuals were submitted to collections on the treadmill with inclinations of 0%, 5% and 10%. A three-minute rest period was given between the different conditions. The overall duration of the treadmill session was of approximately 14 minutes.
Intervention code [1] 256471 0
Not applicable
Comparator / control treatment
Spatial-temporal variables were observed as well as the angular variation of the hip, knee and ankle in the sagittal plane while the individuals walked on the treadmill at three different inclinations (0%, 5% and 10%).
Control group
Active

Outcomes
Primary outcome [1] 258452 0
Comparing of variables between 0% and 5% of inclination as measured by digitised video analysis showed that the stance time increased 4,8%.
In the hip, flexion at initial contact increased 13%, flexion at swing increased 10,2%, there was a decrease of 13% in maximum extension during terminal stance.
Timepoint [1] 258452 0
After two minutes in 5% of inclination
Primary outcome [2] 258453 0
Comparing of variables between 0% and 10% of inclination as measured by digitised video analysis showed that the stance time increased 6%.
In the hip, flexion at initial contact increased 29,7%, flexion at swing increased 25,2%. There was a decrease of 25,2% in maximum extension during terminal stance. An increase of 8,7% was also observed in range of motion in the hip.
In the knee, flexion at initial contact increased 30%, maximum stance flexion increased 21,4%, range of motion increased 5,8%. In the ankle, there was decrease of 67,7% in the plantar flexed.
Timepoint [2] 258453 0
After two minutes in 10% of inclination
Secondary outcome [1] 264245 0
Comparing of variables between 5% and 10% of inclination as measured by digitised video analysis showed in the hip, flexion at initial contact increased 14,8%, flexion at swing increased 13,6%. There was a decrease of 14% in maximum extension during terminal stance. An increase of 6,0% was also observed in range of motion in the hip.
In the knee, flexion at initial contact increased 19,6%, maximum stance flexion increased 17%. In the ankle, there was increase of 43,6% in the maximum swing dorsiflexion.
Timepoint [1] 264245 0
After two minutes in 10% of inclination

Eligibility
Key inclusion criteria
Hemiparesis resulting from a single ischemic or hemorrhagic stroke event, spasticity classified between levels 0 and 2 on the Modified Ashworth Scale of Muscle Spasticity for the lower limb affected; ambulatory capacity classified between levels 3 and 5 on the Functional Ambulatory Classification - FAC; minimum sequela time of 6 months; absence of clinical signs of cardiac alterations, arrhythmia or angina (New York Heart Association, degree I); absence of other orthopedic or neurological impairment that caused gait alterations; not using orthesis on the paretic lower limb; and capacity to obey simple verbal commands.
Minimum age
39 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals whose systolic blood pressure rose 10mmHg during the treadmill test or whose heart rate exceeded 75% of age-adjusted maximum heart rate and those who were phobic.

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
3/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 2627 0
Brazil
State/province [1] 2627 0

Funding & Sponsors
Funding source category [1] 256968 0
Government body
Name [1] 256968 0
Fundacao de Apoio a Pesquisa do Rio Grande do Norte - FAPERN
Country [1] 256968 0
Brazil
Primary sponsor type
University
Name
Universidade Federal do Rio Grande do Norte
Address
Av. Senador Salgado Filho, 3000
Caixa Postal 1524
Natal - RN
CEP 59072-970
Country
Brazil
Secondary sponsor category [1] 256229 0
None
Name [1] 256229 0
Address [1] 256229 0
Country [1] 256229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258984 0
Comite de Etica em Pesquisa do Hospital Universitario Onofre Lopes
Ethics committee address [1] 258984 0
Ethics committee country [1] 258984 0
Brazil
Date submitted for ethics approval [1] 258984 0
Approval date [1] 258984 0
04/05/2007
Ethics approval number [1] 258984 0
1/07/0007

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

Contacts
Principal investigator
Name 31161 0
Address 31161 0
Country 31161 0
Phone 31161 0
Fax 31161 0
Email 31161 0
Contact person for public queries
Name 14408 0
Ana Raquel Rodrigues Lindquist
Address 14408 0
Universidade Federal do Rio Grande do Norte
Centro de Ciencias da Saude
Departamento de Fisioterapia
Av. Senador Salgado Filho, 3000
Caixa Postal 1524
Natal - RN
CEP 59072-970
Country 14408 0
Brazil
Phone 14408 0
55 84 3342 2010
Fax 14408 0
55 84 3342 2000
Email 14408 0
[email protected]
Contact person for scientific queries
Name 5336 0
Cinthia de Carvalho Moreno
Address 5336 0
Rua Praia de Buzios, 184
Nova Parnamirim
Parnamirim - RN
CEP 59151-450
Country 5336 0
Brazil
Phone 5336 0
55 84 3208 5778
Fax 5336 0
55 84 3234 3980
Email 5336 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.