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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01958736
Registration number
NCT01958736
Ethics application status
Date submitted
7/10/2013
Date registered
9/10/2013
Date last updated
19/10/2016
Titles & IDs
Public title
Ballistic Strength Training in Stroke: A Pilot Study
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Scientific title
Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
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Secondary ID [1]
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369/13
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Ballistic Strength Training
Other interventions - Usual Care Physiotherapy
Experimental: Experimental - Ballistic Strength Training
Active Comparator: Control - Usual care Physiotherapy
Other interventions: Ballistic Strength Training
The experimental group will complete jump squats on the leg sled, single leg toe push offs (or bilateral where unable to complete single), alternating legs (i.e. bounding), mini tramp jumping, progressing to jogging, quick hip flexion and bounding on land.
Other interventions: Usual Care Physiotherapy
This group will complete a suite of exercises based upon existing rehabilitation practices that aim to improve mobility after stroke. The supervising physiotherapist will select and progress the exercises, recording the performance of exercises in an exercise log and detailing incidence of adverse events. Exercise selection will include: gait retraining, cardiovascular fitness, lower limb strengthening, static and dynamic balance.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Recruitment:
Number of stroke admissions to Caulfield Hospital
Number of stroke admissions that meet the inclusion/exclusion criteria
Number of those eligible who consent to participate
Retention/Attrition:
Drop out rates over the six week period and reasons for drop outs
Number of sessions attended out of 18 over the six week period
Clinical feasibility
Capacity of participants to perform the required exercises
Level of assistance required by therapist to perform the exercises - i.e. independent, supervision, assisted
Barriers to completing the required exercises during a session, i.e. incidence of delayed onset muscle soreness, fatigue
To be recorded for every session
Safety
Incidence of adverse events
Types of adverse events
To be recorded for every session
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Timepoint [1]
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6 weeks
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Secondary outcome [1]
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10 metre walk test comfortable pace
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Assessment method [1]
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Participants will be measured at comfortable gait speed. The middle 10metres of a 14 metre track will be recorded. The participant will be asked to walk at their own comfortable speed. There will be a cone at the start and finish of the 14metre track to guide participants and the middle 10 metres will be recorded.
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Timepoint [1]
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Baseline and 6 weeks
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Secondary outcome [2]
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10 metre walk test, maximum safe pace
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Assessment method [2]
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Same set-up as 10MWT comfortable pace, however the participant will be asked to walk as fast as they safely can without breaking into a run.
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Timepoint [2]
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Baseline and 6 weeks
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Secondary outcome [3]
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High level mobility assessment tool (HiMAT)
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Assessment method [3]
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The HiMAT is a 13 item assessment tool designed to assess high level walking tasks, the ability to negotiate stairs and the ability to run, hop, skip and jump. The HiMAT will be used to evaluate performance for higher level participants in the study where their 10MWT result may have a ceiling effect (where participants complete 10MWT in under 12.5seconds).
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Timepoint [3]
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Baseline and 6 weeks
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Secondary outcome [4]
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Timed up and go test (TUG)
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Assessment method [4]
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The TUG is highly reliable in stroke populations and correlates with walking performance and incidence of falls. Participants will be measured on the TUG from a 45cm chair. The will be asked to complete the test at their own comfortable speed.
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Timepoint [4]
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Baseline and 6 weeks
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Secondary outcome [5]
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Functional Ambulation Category (FAC)
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Assessment method [5]
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The FAC is a simple tool which uses an ordinal scale of 1 to 6 to measure the level of assistance a person requires to walk, and the different types of terrain they can manage such as indoors vs. outdoors, slopes and inclines.
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Timepoint [5]
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Baseline and 6 weeks
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Secondary outcome [6]
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Assessment of quality of life 4D
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Assessment method [6]
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Health related quality of Life will be measured using the Assessment of quality of life 4D. This has been shown to be a valid and sensitive measure in stroke, and has been used to determine the effects of mobility on HRQoL in neurological populations.
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Timepoint [6]
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Baseline and 6 weeks
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Eligibility
Key inclusion criteria
- Inpatient at Caulfield Hospital Neurological Rehabilitation Unit at the time of
recruitment
- Diagnosis of first stroke
- Presence of lower limb weakness determined by >10% difference in knee extensor
strength between sides
- Functional Ambulation Category (FAC) > 3
- Can walk a minimal distance of 14 metres (to allow measurement on a 10metre walk test
(10MWT)
Participants who meet all the inclusion criteria except for their FAC score will have their
FAC score re-measured on a weekly basis until they reach a score of greater than or equal
to 3, at which point they become eligible and will be approached for recruitment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unable to provide informed consent (determined by consultation with rehabilitation
consultant and the team neuropsychologist)
- Other diagnosed central nervous system disorder affecting mobility
- Active oncological diagnosis
- Unstable medication condition such as unstable diabetes or unstable cardiac condition
that would prevent participation in cardiovascular activity
- Recent orthopaedic trauma and/or osteoarthritis that would limit participation in
physical exercise
- Not willing to continue to attend the program if they discharge home before the end of
the six week program
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2016
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Sample size
Target
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Caulfield Hospital - Melbourne
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Recruitment postcode(s) [1]
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3162 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian Catholic University
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This pilot study intends to evaluate whether stroke patients can complete ballistic strength
exercises for thirty minutes, three times per week over a six week training period in
addition to their existing rehabilitation program.
It will evaluate whether using ballistic training principles, is superior in improving
mobility compared with usual care exercises to improve mobility and leg strength in stroke
patients.
In this study there will be 15 participants per group, a total of 30 participants. The
control group will receive usual care consistent with existing rehabilitation practice and
literature. The experimental group will perform task specific strength training in a
ballistic fashion.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01958736
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Genevieve C Hendrey, B Phys (Hons)
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01958736
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