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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12609000803291 |
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Date of registration:
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16/09/2009 |
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Primary sponsor: |
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Public title:
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Effects of strengthening exercises addition on task-specific gait training after stroke: a randomised controlled trial
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Scientific title:
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Strengthening exercises to improve walking disability in acute stroke patients. |
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Date of first enrolment:
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25/06/2009 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12609000803291.aspx |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
Parallel |
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Aline Alvim Scianni |
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Address:
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Avenida Dom Jose Gaspar 500 - PUC- Belo Horizonte, Brazil
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Telephone:
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55 31 33194425 |
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Email:
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ascianni@task.com.br |
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Affiliation:
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Name:
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Aline Alvim Scianni |
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Address:
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Avenida Dom Jose Gaspar 500 - PUC- Belo Horizonte, Brazil
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Telephone:
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55 31 33194425 |
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Email:
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ascianni@task.com.br |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Stroke patients will be eligible if they had clinical diagnosis of a first stroke resulting walking deficit; they are living at home for less than 6 months having been discharged from hospital post stroke; they are older than 20 years of age; they are diagnosed clinically with hemiparesis or hemiplegia; they can walk 10 metres independently using aids or orthoses, with or without supervision, their walking velocity is within 0.4 to 0.8 m/s (limited community)
Exclusion criteria: They will be excluded if they have severe cognitive deficits assessed by the Mini-Mental State Exam and/or language problems (comprehensive aphasia), evaluated by simple motor commands, which could prevent them from following instructions during measurement and/or intervention; they have adverse health conditions, which could affect balance and mobility, such as vestibular disturbances, severe arthritis or other neurological disorders.
Age minimum:
20 Years
Age maximum:
0 No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Hemiplegia
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Intervention(s)
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The experimental group will undertake task-specific walking training plus targeted strength training 3 times per week over 10 weeks. The overall duration of the section will be approximately 60 minutes (30 minutes of task-specific walking training and 30 minutes of strength training). Task-specific walking training plus targeted strength training: The 30-minute sessions of task-specific walking training will include practising part of the task (= 20 min) where muscles are working in a similar manner to full task performance and practising the whole task (= 10 min). Additionally, of the12 lower limb muscle groups (hip flexors, extensors, abductors, adductors, internal and external rotators; knee flexors and extensors, and ankle dorsiflexors, plantarflexors, invertors and evertors), all those Grade 4 or less on Manual Muscle Test (MMT) will undergo training. For very weak muscles (Grade 1 on Manual Muscle Test), strengthening exercises will be set up so that minimal muscle activity will result in movement. This will be achieved by focusing on the mid-range of muscle length; decreasing the effect of gravity; decreasing friction and decreasing the lever arm of the limb. Progression of exercises (Grade 2 on Manual Muscle Test), will focus on range of motion; sustaining contractions; increasing speed; beginning to add resistance to mid-range and resisted exercises. Once resistance can be introduced (Grade =3 on Manual Muscle Test), it will be implemented using weight machines, free weights and body weight. Programs will be individually-tailored and 50% of 1 Repetition Maximum (the maximum weight that can be lifted on a single occasion) will be used to set the initial load. Participants will be instructed to perform three sets of 10 repetitions for each exercise with a 1–2 minute rest period between sets. Then, the load will be increased to 80% of 1 repetition maximum (RM) and the training stimulus will be adjusted to stay at this load every two weeks.
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Primary Outcome(s)
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Lower limb motor coordination. Motor coordination will be measured using the Lower Extremity Motor Coordination Test (LEMOCOT). It consists of moving the lower extremity as fast as possible from 1 target to another for 20 seconds.
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Lower limb muscle strength. Strength of all 12 lower limb muscles will be measured using hand-held dynamometry.
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Walking ability.
Walking ability will be quantified by parameters such as speed (m/s), step length (m), and cadence (steps/min).
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Secondary Outcome(s)
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Minimal clinically important difference (MCID) of 3 outcome measures (lower limb strength, motor coordination and gait speed) will be estimated using the method of patient?s global ratings of change.
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Quality of life.
The Stroke Specific Quality of Life Scale (SS-QOL)(39) will be used to measure participation. It consists of a single stroke outcome measure that assesses the various domains important in determining stroke-specific health related quality of life across the spectrum of stroke symptoms and severity.
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Source(s) of Monetary Support
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CAPES - Coordenacao de aperfeicoamento de pessoal de nivel superior
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