Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12611001098921
Ethics application status
Approved
Date submitted
18/10/2011
Date registered
21/10/2011
Date last updated
18/01/2022
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Is ballistic strength training more effective than usual care for improving mobility following traumatic brain injury (TBI)?
Query!
Scientific title
Is ballistic strength training more effective than usual care for improving mobility following traumatic brain injury (TBI)?
Query!
Secondary ID [1]
262820
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1123-6619
Query!
Trial acronym
TBStrong
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury
270542
0
Query!
Mobility Limitations
270543
0
Query!
Condition category
Condition code
Neurological
270700
270700
0
0
Query!
Other neurological disorders
Query!
Physical Medicine / Rehabilitation
270701
270701
0
0
Query!
Physiotherapy
Query!
Injuries and Accidents
279191
279191
0
0
Query!
Other injuries and accidents
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The intervention group will perform ballistic strength training exercises in a context specific manner according to the American College of Sports Medicine (ACSM) guidelines to ensure an optimal training stimulus and transfer of training gains. Participants will perform ballistic strength training exercises tailored to the severity of their strength deficits. The major muscle groups of the lower limbs responsible for mobility will be targeted ballistically in functional positions. They include the hip flexors and extensors, knee flexors and extensors, and ankle plantarflexors. Strength training is a relatively safe intervention with very few adverse events reported for people with neurological conditions. In order to ensure the exercises are conducted in a ballistic manner, a physiotherapist will supervise each session. The supervising physiotherapists will be responsible for ensuring that exercises are completed according to four key criteria. These are 1) Type of muscle contraction (concentric/isometric/eccentric), 2) Targeted range of motion (ROM), 3) Speed and 4) Load. Participants will have 3 one-hour sessions/week for 12 weeks in a 1:1 format supervised by a physiotherapist.
Query!
Intervention code [1]
269169
0
Rehabilitation
Query!
Comparator / control treatment
Participants randomized to the control group will perform a range of exercises that represent usual care. In order to define usual care, a two stage process was performed. Firstly, the TBI literature was reviewed in relation to which types of therapy people receive for mobility limitations, and an audit of usual care was conducted. The main therapies reported for mobility limitations were balance exercises, lower limb stretching and strengthening exercises, and cardiovascular fitness training.
The audit of usual care was used to determine the proportion of time that participants in the usual care group should spend on each type of therapy. The results showed that in a standard one-hour session, people with TBI usually spend the majority of their time on balance exercises, strengthening, stretching and cardiovascular fitness.
Participants in the usual care group will perform a range of static and dynamic balance activities with a protocol for progression built in. They will also stretch the main muscle groups of the lower limbs, and perform cardiovascular exercise (exercise bike or arm ergometer) under constant heart rate monitoring to ensure that participants exercise in their predetermined training zone.
Participants will have 3 one-hour sessions/week for 12 weeks in a 1:1 format supervised by a physiotherapist.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
269416
0
High-Level Mobility Assessment Tool (HiMAT)
Query!
Assessment method [1]
269416
0
Query!
Timepoint [1]
269416
0
End of 12 week intervention phase
3 month follow-up
Query!
Secondary outcome [1]
287582
0
Self-selected walking speed
Query!
Assessment method [1]
287582
0
Query!
Timepoint [1]
287582
0
End of 12 week intervention phase
3 month follow-up
Query!
Secondary outcome [2]
287583
0
Balance - Single limb support time (left and right legs, eyes open and eyes closed)
Query!
Assessment method [2]
287583
0
Query!
Timepoint [2]
287583
0
End of 12 week intervention phase
3 month follow-up
Query!
Secondary outcome [3]
287584
0
Strength - 6RM seated leg press
Query!
Assessment method [3]
287584
0
Query!
Timepoint [3]
287584
0
End of 12 week intervention phase
3 month follow-up
Query!
Secondary outcome [4]
287585
0
Quality of Life (AQoL-6D)
Query!
Assessment method [4]
287585
0
Query!
Timepoint [4]
287585
0
End of 12 week intervention phase
3 month follow-up
Query!
Secondary outcome [5]
307368
0
Muscle Power Generation
Participants will be asked to perform a one-legged jump on their more-affected leg whilst lying on a reclined leg sled (LS). Participants will complete a series of five jumps at 50% of 1RM (as calculated during the muscle strength testing). The displacement occurring during each repetition will be recorded using a string potentiometer sampling at 200Hz, with data acquired via a customized LabVIEW software program (National Instruments, USA).
Query!
Assessment method [5]
307368
0
Query!
Timepoint [5]
307368
0
End of 12 week intervention phase and 3 month follow up
Query!
Eligibility
Key inclusion criteria
Participants must have a neurologically based movement disorder affecting mobility as a result of TBI and be less than 12 months post injury.
Query!
Minimum age
15
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- were unwilling or unable to provide informed consent
- have a previously diagnosed central nervous system disorder
- have severe cognitive or behavioural problems that prevent assessment
- have orthopaedic injuries restricting mobility
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random sequence of group allocation will be concealed from the person recruiting patients. Group allocation will be concealed using consecutively-numbered opaque envelopes. The opaque envelope will be opened after completion of the assessment in the presence of the participant.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule has been prepared by the trial biostatistician who is not involved in recruitment or assessment. In addition, participants will be stratified according to initial level of gait disability. Within each of the two strata (moderate level of disability - HiMAT score greater than or equal to 27; severe level of disability- HiMAT score <27), patients will be allocated randomly to either group. Random permuted blocks will be used so that after every block the two groups will contain approximately equal numbers.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/12/2011
Query!
Actual
9/03/2012
Query!
Date of last participant enrolment
Anticipated
14/06/2021
Query!
Actual
22/06/2021
Query!
Date of last data collection
Anticipated
24/12/2021
Query!
Actual
17/11/2021
Query!
Sample size
Target
132
Query!
Accrual to date
Query!
Final
131
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
7560
0
Caulfield Hospital - Caulfield
Query!
Recruitment hospital [2]
7561
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [3]
7562
0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Query!
Recruitment hospital [4]
15187
0
Hampstead Rehabilitation Centre - Northfield
Query!
Recruitment postcode(s) [1]
28496
0
5085 - Northfield
Query!
Funding & Sponsors
Funding source category [1]
269644
0
Hospital
Query!
Name [1]
269644
0
Epworth Hospital
Query!
Address [1]
269644
0
89 Bridge Rd
Richmond 3121
Victoria
Query!
Country [1]
269644
0
Australia
Query!
Funding source category [2]
295733
0
Government body
Query!
Name [2]
295733
0
NHMRC Project Grant APP1104237
Query!
Address [2]
295733
0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Query!
Country [2]
295733
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Epworth Hospital
Query!
Address
89 Bridge Rd
Richmond 3121
Victoria
Query!
Country
Australia
Query!
Secondary sponsor category [1]
266676
0
University
Query!
Name [1]
266676
0
The University of Melbourne
Query!
Address [1]
266676
0
Carlton 3010
Victoria
Query!
Country [1]
266676
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
269587
0
Epworth Hospital HREC
Query!
Ethics committee address [1]
269587
0
c/o Epworth Hospital 89 Bridge Rd Richmond 3121 Victoria
Query!
Ethics committee country [1]
269587
0
Australia
Query!
Date submitted for ethics approval [1]
269587
0
05/10/2011
Query!
Approval date [1]
269587
0
26/10/2011
Query!
Ethics approval number [1]
269587
0
53211
Query!
Ethics committee name [2]
297037
0
Alfred Health
Query!
Ethics committee address [2]
297037
0
55 Commercial Rd, Melbourne VIC 3004
Query!
Ethics committee country [2]
297037
0
Australia
Query!
Date submitted for ethics approval [2]
297037
0
28/04/2016
Query!
Approval date [2]
297037
0
09/05/2016
Query!
Ethics approval number [2]
297037
0
HREC/16/Alfred/31 (Local Reference: Project 144/16)
Query!
Ethics committee name [3]
297038
0
Liverpool Hospital
Query!
Ethics committee address [3]
297038
0
South Western Sydney Local Health District Locked Bag 7103, LIVERPOOL BC, NSW, 1871
Query!
Ethics committee country [3]
297038
0
Australia
Query!
Date submitted for ethics approval [3]
297038
0
30/12/2016
Query!
Approval date [3]
297038
0
07/12/2017
Query!
Ethics approval number [3]
297038
0
SSA/16/LPOOL/342; HE16/177
Query!
Ethics committee name [4]
297039
0
Royal Rehab
Query!
Ethics committee address [4]
297039
0
235 Morrison Rd Ryde NSW 1680
Query!
Ethics committee country [4]
297039
0
Australia
Query!
Date submitted for ethics approval [4]
297039
0
11/12/2016
Query!
Approval date [4]
297039
0
16/01/2017
Query!
Ethics approval number [4]
297039
0
16SSA10: Research Project: HREC/16/Alfred/31; SSA-AU/2/32DA28
Query!
Ethics committee name [5]
308653
0
Central Adelaide Local Health Network HREC
Query!
Ethics committee address [5]
308653
0
Central Adelaide Local Health Network Research Office Level 3, Roma Mitchell House North Terrace, Adelaide SA Australia 5000
Query!
Ethics committee country [5]
308653
0
Australia
Query!
Date submitted for ethics approval [5]
308653
0
22/04/2019
Query!
Approval date [5]
308653
0
11/09/2019
Query!
Ethics approval number [5]
308653
0
SSA/19/CALHN/190
Query!
Summary
Brief summary
Traumatic brain injury (TBI) is the leading cause of death and disability amongst adolescents and young adults. The incidence of TBI in Australia is 300 per 100,000, of which 20% are classified moderate to severe. The prevalence of TBI in the community is high because of the survival rate and the demographic groups at most risk are adolescents and young adults. Although a minority of people who sustain a moderate to severe TBI can expect to make a full recovery, over 75% of victims never return to full independence and function. In contrast to the vast literature on neuropsychological impairments following TBI, surprisingly little information is known about the effect of the brain injury on gait. My recent systematic review found the key biomechanical abnormalities of gait were yet to be determined. Further, the key physical impairments contributing to mobility limitations have not been established. Several studies have suggested balance may be primarily responsible. Although balance, spasticity, contracture, muscle weakness and inco-ordination may all contribute to mobility limitations, my research has identified that balance and strength deficits are most prevalent, but the primary cause of mobility limitations was muscle weakness. Physiotherapy is routinely provided to treat the physical impairments that contribute to mobility limitations in order to optimize rehabilitation outcomes for people with TBI. Balance training and muscle strengthening programs are widely used. Strong evidence exists indicating balance training improves balance disorders and strength training improves muscle weakness in neurological populations, yet little evidence exists supporting the impact of either intervention on mobility limitations. Further, a recent international symposium on research priorities for TBI highlighted the urgent need for rehabilitative therapy research as virtually no level 1 evidence exists. The primary aim of this research program is to investigate whether ballistic strength training is more effective than usual carer for improving mobility following TBI. The research program constitutes a randomised controlled trial (RCT) comparing ballistic strength training and usual care for improving mobility following TBI.
Query!
Trial website
Query!
Trial related presentations / publications
Williams G, Ada L, Hassett L, Morris M E, Clark R, Bryant A L, Olver J. Ballistic strength training compared with usual care for improving mobility following traumatic brain injury: protocol for a randomised controlled trial. Journal of Physiotherapy. 2016;62(3):164.
Query!
Public notes
Query!
Attachments [1]
1535
1535
0
0
/AnzctrAttachments/343328-RCT protocol.pdf
(Protocol)
Query!
Query!
Contacts
Principal investigator
Name
33006
0
A/Prof Gavin Williams
Query!
Address
33006
0
c/o Physiotherapy Department Epworth Hospital 89 Bridge Rd Richmond 3121 Victoria
Query!
Country
33006
0
Australia
Query!
Phone
33006
0
+613 9426 8727
Query!
Fax
33006
0
Query!
Email
33006
0
[email protected]
Query!
Contact person for public queries
Name
16253
0
Gavin Williams
Query!
Address
16253
0
c/o Physiotherapy Department
Epworth Hospital
89 Bridge Rd
Richmond 3121
Victoria
Query!
Country
16253
0
Australia
Query!
Phone
16253
0
+613 9426 8727
Query!
Fax
16253
0
+613 9426 8734
Query!
Email
16253
0
[email protected]
Query!
Contact person for scientific queries
Name
7181
0
Gavin Williams
Query!
Address
7181
0
c/o Physiotherapy Department
Epworth Hospital
89 Bridge Rd
Richmond 3121
Victoria
Query!
Country
7181
0
Australia
Query!
Phone
7181
0
+613 9426 8727
Query!
Fax
7181
0
+613 9426 8734
Query!
Email
7181
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
11852
Study protocol
Williams, G., et al. (2016). "Ballistic strength training compared with usual care for improving mobility following traumatic brain injury: protocol for a randomised, controlled trial." Journal of Physiotherapy 62(3): 164.
11853
Statistical analysis plan
[email protected]
11854
Informed consent form
343328-(Uploaded-20-10-2020-16-02-53)-Study-related document.doc
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.
Download to PDF