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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
Secondary ID [1] 0 0
369/13
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility
Assessment method [1] 0 0
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
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
10 metre walk test comfortable pace
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline and 6 weeks
Secondary outcome [2] 0 0
10 metre walk test, maximum safe pace
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline and 6 weeks
Secondary outcome [3] 0 0
High level mobility assessment tool (HiMAT)
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
Baseline and 6 weeks
Secondary outcome [4] 0 0
Timed up and go test (TUG)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Baseline and 6 weeks
Secondary outcome [5] 0 0
Functional Ambulation Category (FAC)
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline and 6 weeks
Secondary outcome [6] 0 0
Assessment of quality of life 4D
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline and 6 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Caulfield Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3162 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Catholic University
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Genevieve C Hendrey, B Phys (Hons)
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01958736