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Trial registered on ANZCTR


Registration number
ACTRN12609000803291
Ethics application status
Approved
Date submitted
11/09/2009
Date registered
16/09/2009
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of strengthening exercises addition on task-specific gait training after stroke: a randomised controlled trial
Scientific title
Strengthening exercises to improve walking disability in acute stroke patients.
Universal Trial Number (UTN)
U1111-1111-8007
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiplegia 243811 0
Condition category
Condition code
Stroke 239984 239984 0 0
Ischaemic
Stroke 239985 239985 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241253 0
Rehabilitation
Comparator / control treatment
The control group will undertake task-specific walking training 3 times per week over 10 weeks. 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).
Control group
Active

Outcomes
Primary outcome [1] 240883 0
Lower limb muscle strength. Strength of all 12 lower limb muscles will be measured using hand-held dynamometry.
Timepoint [1] 240883 0
At baseline,10 weeks after randomisation; 4 weeks after treatment cessation.
Primary outcome [2] 240884 0
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.
Timepoint [2] 240884 0
At baseline, 10 weeks after randomisation; 4 weeks after treatment cessation.
Primary outcome [3] 240885 0
Walking ability.
Walking ability will be quantified by parameters such as speed (m/s), step length (m), and cadence (steps/min).
Timepoint [3] 240885 0
At baseline, 10 weeks after randomisation; 4 weeks after treatment cessation.
Secondary outcome [1] 257552 0
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.
Timepoint [1] 257552 0
At baseline, 10 weeks after randomisation; 4 weeks after treatment cessation.
Secondary outcome [2] 257553 0
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.
Timepoint [2] 257553 0
10 weeks after randomisation

Eligibility
Key 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)
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated into either an experimental group or a control group from unveiling the sealed opaque envelopes by the treating therapist. The experimental group will undertake task-specific walking training plus targeted strength training 3 times per week over 10 weeks while the control group will undertake task-specific walking training only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of randomisation will be computer generated in random computed blocks of 4-6 participants and maintained in sealed opaque envelopes. Envelopes will be prepared prior to the study by a trained physiotherapy student not involved in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
25/06/2009
Actual
25/06/2009
Date of last participant enrolment
Anticipated
Actual
30/11/2010
Date of last data collection
Anticipated
30/11/2010
Actual
30/11/2010
Sample size
Target
40
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 2132 0
Brazil
State/province [1] 2132 0
MG/Belo Horizonte

Funding & Sponsors
Funding source category [1] 243711 0
Government body
Name [1] 243711 0
CAPES - Coordenacao de aperfeicoamento de pessoal de nivel superior
Country [1] 243711 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Minas Gerais
Address
Av. Antonio Carlos, 6627 - Pampulha 31270-901 - BELO HORIZONTE - MG
Country
Brazil
Secondary sponsor category [1] 237074 0
None
Name [1] 237074 0
Address [1] 237074 0
Country [1] 237074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243841 0
Comitede etica em pesquisa da UFMG-COEP
Ethics committee address [1] 243841 0
Ethics committee country [1] 243841 0
Brazil
Date submitted for ethics approval [1] 243841 0
01/04/2009
Approval date [1] 243841 0
20/05/2009
Ethics approval number [1] 243841 0
ETIC 120/09

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

Contacts
Principal investigator
Name 30267 0
Address 30267 0
Country 30267 0
Phone 30267 0
Fax 30267 0
Email 30267 0
Contact person for public queries
Name 13514 0
Aline Alvim Scianni
Address 13514 0
Avenida Dom Jose Gaspar 500 - PUC- Belo Horizonte
Country 13514 0
Brazil
Phone 13514 0
55 31 33194425
Fax 13514 0
Email 13514 0
ascianni@task.com.br
Contact person for scientific queries
Name 4442 0
Aline Alvim Scianni
Address 4442 0
Avenida Dom Jose Gaspar 500 - PUC- Belo Horizonte
Country 4442 0
Brazil
Phone 4442 0
55 31 33194425
Fax 4442 0
Email 4442 0
ascianni@task.com.br

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.