Trial Review

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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
Date results information initially provided
18/01/2022
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)?
Scientific title
Is ballistic strength training more effective than usual care for improving mobility following traumatic brain injury (TBI)?
Secondary ID [1] 262820 0
Nil
Universal Trial Number (UTN)
U1111-1123-6619
Trial acronym
TBStrong
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 270542 0
Mobility Limitations 270543 0
Condition category
Condition code
Neurological 270700 270700 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 270701 270701 0 0
Physiotherapy
Injuries and Accidents 279191 279191 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269169 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 269416 0
High-Level Mobility Assessment Tool (HiMAT)
Timepoint [1] 269416 0
End of 12 week intervention phase
3 month follow-up
Secondary outcome [1] 287582 0
Self-selected walking speed
Timepoint [1] 287582 0
End of 12 week intervention phase
3 month follow-up
Secondary outcome [2] 287583 0
Balance - Single limb support time (left and right legs, eyes open and eyes closed)
Timepoint [2] 287583 0
End of 12 week intervention phase
3 month follow-up
Secondary outcome [3] 287584 0
Strength - 6RM seated leg press
Timepoint [3] 287584 0
End of 12 week intervention phase
3 month follow-up
Secondary outcome [4] 287585 0
Quality of Life (AQoL-6D)
Timepoint [4] 287585 0
End of 12 week intervention phase
3 month follow-up
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).
Timepoint [5] 307368 0
End of 12 week intervention phase and 3 month follow up

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

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
9/03/2012
Date of last participant enrolment
Anticipated
14/06/2021
Actual
22/06/2021
Date of last data collection
Anticipated
24/12/2021
Actual
17/11/2021
Sample size
Target
132
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 7560 0
Caulfield Hospital - Caulfield
Recruitment hospital [2] 7561 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 7562 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [4] 15187 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 28496 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 269644 0
Hospital
Name [1] 269644 0
Epworth Hospital
Country [1] 269644 0
Australia
Funding source category [2] 295733 0
Government body
Name [2] 295733 0
NHMRC Project Grant APP1104237
Country [2] 295733 0
Australia
Primary sponsor type
Hospital
Name
Epworth Hospital
Address
89 Bridge Rd
Richmond 3121
Victoria
Country
Australia
Secondary sponsor category [1] 266676 0
University
Name [1] 266676 0
The University of Melbourne
Address [1] 266676 0
Carlton 3010
Victoria
Country [1] 266676 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269587 0
Epworth Hospital HREC
Ethics committee address [1] 269587 0
c/o Epworth Hospital
89 Bridge Rd
Richmond 3121
Victoria
Ethics committee country [1] 269587 0
Australia
Date submitted for ethics approval [1] 269587 0
05/10/2011
Approval date [1] 269587 0
26/10/2011
Ethics approval number [1] 269587 0
53211
Ethics committee name [2] 297037 0
Alfred Health
Ethics committee address [2] 297037 0
55 Commercial Rd,
Melbourne
VIC 3004
Ethics committee country [2] 297037 0
Australia
Date submitted for ethics approval [2] 297037 0
28/04/2016
Approval date [2] 297037 0
09/05/2016
Ethics approval number [2] 297037 0
HREC/16/Alfred/31 (Local Reference: Project 144/16)
Ethics committee name [3] 297038 0
Liverpool Hospital
Ethics committee address [3] 297038 0
South Western Sydney Local Health District
Locked Bag 7103,
LIVERPOOL BC,
NSW, 1871
Ethics committee country [3] 297038 0
Australia
Date submitted for ethics approval [3] 297038 0
30/12/2016
Approval date [3] 297038 0
07/12/2017
Ethics approval number [3] 297038 0
SSA/16/LPOOL/342; HE16/177
Ethics committee name [4] 297039 0
Royal Rehab
Ethics committee address [4] 297039 0
235 Morrison Rd
Ryde
NSW 1680
Ethics committee country [4] 297039 0
Australia
Date submitted for ethics approval [4] 297039 0
11/12/2016
Approval date [4] 297039 0
16/01/2017
Ethics approval number [4] 297039 0
16SSA10: Research Project: HREC/16/Alfred/31; SSA-AU/2/32DA28
Ethics committee name [5] 308653 0
Central Adelaide Local Health Network HREC
Ethics committee address [5] 308653 0
Central Adelaide Local Health Network
Research Office
Level 3, Roma Mitchell House
North Terrace, Adelaide SA
Australia 5000
Ethics committee country [5] 308653 0
Australia
Date submitted for ethics approval [5] 308653 0
22/04/2019
Approval date [5] 308653 0
11/09/2019
Ethics approval number [5] 308653 0
SSA/19/CALHN/190

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.
Trial website
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.
Public notes
Attachments [1] 1535 1535 0 0
/AnzctrAttachments/343328-RCT protocol.pdf (Protocol)

Contacts
Principal investigator
Name 33006 0
A/Prof Gavin Williams
Address 33006 0
c/o Physiotherapy Department Epworth Hospital 89 Bridge Rd Richmond 3121 Victoria
Country 33006 0
Australia
Phone 33006 0
+613 9426 8727
Fax 33006 0
Email 33006 0
[email protected]
Contact person for public queries
Name 16253 0
A/Prof Gavin Williams
Address 16253 0
c/o Physiotherapy Department
Epworth Hospital
89 Bridge Rd
Richmond 3121
Victoria
Country 16253 0
Australia
Phone 16253 0
+613 9426 8727
Fax 16253 0
+613 9426 8734
Email 16253 0
[email protected]
Contact person for scientific queries
Name 7181 0
A/Prof Gavin Williams
Address 7181 0
c/o Physiotherapy Department
Epworth Hospital
89 Bridge Rd
Richmond 3121
Victoria
Country 7181 0
Australia
Phone 7181 0
+613 9426 8727
Fax 7181 0
+613 9426 8734
Email 7181 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11852Study protocolWilliams, 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.  
11853Statistical analysis plan  [email protected]
11854Informed 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.