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
Trial registered on ANZCTR


Registration number
ACTRN12621001073897
Ethics application status
Approved
Date submitted
17/06/2021
Date registered
13/08/2021
Date last updated
29/11/2022
Date data sharing statement initially provided
13/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of implementing Ballistic Strength Training to improve mobility outcomes of inpatients with Traumatic Brain Injury.
Scientific title
Feasibility of implementing Ballistic Strength Training to improve mobility outcomes of inpatients with Traumatic Brain Injury.
Secondary ID [1] 303998 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 321611 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319352 319352 0 0
Physiotherapy
Neurological 319979 319979 0 0
Other neurological disorders
Injuries and Accidents 320307 320307 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ballistic Strength Training (BST) is a form of strength training aimed at improving muscle power generation also known as the rate of force production. BST is intentionally performed at high velocity with light loads and a focus on high repetition.

Participants will have two conventional physiotherapy sessions per week replaced by BST, for a maximum of four weeks (eight sessions). Each BST session will last approximately 30 minutes. Each BST session will be done at least 48 hours apart. Each BST session will be performed under direct supervision of physiotherapy team members in the physiotherapy gym at the inpatient rehabilitation centre. Exercise demonstrations and hands-on assistance will be provided to participants where necessary.

Although all major lower limb muscle groups will be strengthened, it will target the three muscles groups critical for power generation during forward propulsion namely; the ankle plantar flexors during push-off in terminal stance, hip flexors at toe-off to accelerate the leg through swing phase and hip extensors at initial contact.

The BST program will consist of two parts. Each part will consist of four exercises. Part A will consist of exercises performed below body weight on a reclined jump trainer. Part B will consist of body weight exercises, using equipment such as parallel bars and a mini-trampoline, with or without upper limb support and additional resistance.

A BST exercise log will be kept per participant, by the researcher. The following will be recorded: ability to complete exercises (yes/no) and skills acquisition of the participants. Skills acquisition refers to the amount of assistance required (assistance/supervision/independent) as well as the appropriate speed required for the task of walking. The desired speed of movement is 60 beats per minute (using a metronome). The number of sessions attended, level of assistance required and reports of discomfort or adverse effects will be recorded for each BST session.
Intervention code [1] 320307 0
Rehabilitation
Intervention code [2] 320825 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327572 0
To establish feasibility of implementing BST in an inpatient rehabilitation setting on PRFTBI, as a composite outcome of the following components:
1. To determine the recruitment rate by investigating the eligibility and uptake rate of the study as assessed by audit of study records.
2. To establish participant safety with BST in the inpatient setting by recording the incidence, type and severity of adverse effects associated with the intervention as assessed by audit of study records, using Common Terminology Criteria for Adverse Events (CTCAE v5).
3. To determine intervention attendance per participant according to the number of sessions attended per participant, as assessed by audit of study records.
4. To determine participant extent of acceptability of the intervention as assessed by audit of study records, using the Visual Analogue Scale (VAS) as recorded by participants post-intervention.
Timepoint [1] 327572 0
Overall outcome timepoint: At the conclusion of the study.
Component 1: At the conclusion of the study.
Component 2: At the conclusion of the study.
Component 3: At the conclusion of the study.
Component 4: VAS recorded post-intervention (timepoint 02) per participant. Outcome determined at the conclusion of the study.
Primary outcome [2] 328366 0
To evaluate clinical feasibility of the intervention within the inpatient rehabilitation setting in PRFTBI as a composite outcome of the following components:
1. The ability of participants to complete the exercises in the BST intervention protocol, as assessed by audit of exercise logs.
2. Participant skills acquisition of the BST exercises by recording the amount of assistance required (assistance/supervision/independent) and whether the desired speed of movement is achieved. Non-contact phase at 60bpm using a metronome. As assessed by audit of exercise logs.
Timepoint [2] 328366 0
Overall outcome timepoint: At the conclusion of the study.
Component 1: Recorded on participant exercise logs during intervention period. Overall outcome determined at the conclusion of the study.
Component 2: Recorded on participant exercise logs during intervention period. Overall outcome determined at the conclusion of the study.
Secondary outcome [1] 396678 0
To determine the change in self-selected walking speed by using the 10-metre Walk Test (10mWT).
Timepoint [1] 396678 0
Baseline assessment pre-intervention (timepoint 01) and post-intervention (timepoint 02: four weeks post-intervention or at time of discharge if earlier).
Secondary outcome [2] 398743 0
To determine the change in walking capacity by using the 6-Minute Walk Test (6MWT).
Timepoint [2] 398743 0
Baseline assessment pre-intervention (timepoint 01) and post-intervention (timepoint 02: four weeks post-intervention or at time of discharge if earlier).
Secondary outcome [3] 398744 0
To determine the participants’ perceived impression of change in walking ability using a Global Rating of Change (GRoC) Scale.
Timepoint [3] 398744 0
Post-intervention (timepoint 02): four weeks post-intervention or at time of discharge if earlier).

Eligibility
Key inclusion criteria
* First-ever diagnosis of moderate to severe TBI.
* Less than six months post-injury.
* Age 18-65 years.
* Independent, unaided baseline mobility (prior to TBI).
* Able to walk with standby assistance of one therapist for greater than or equal to 14m. Assistive devices and orthoses permitted.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unwilling or unable to obtain consent
* Severe cognitive or behavioural problems that prevent assessment.
* Medically unstable (preventing cardiovascular exercise)
* Recent orthopaedic injuries restricting weight bearing or recent spinal surgery in the last six weeks.
* Lower limb muscle weakness from peripheral cause
* Previously diagnosed central nervous system disorder.
* Walking is not the preferred mode of indoor mobility.
* Independent, unaided with a self-selected walking speed of greater than 1.55m/s.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This feasibility study will have a quasi-experimental single group pretest-posttest design (01 X 02).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To estimate the sample size, sample size calculation was completed by a statistician, even though a powered sample is not required for the purpose of a feasibility study. The power analysis showed that for parametric tests like the paired t-test with a large effect size of 0.6, using G*Power 3.1.9.2, at an alpha level of 5% and a power of 80%, a sample size of 23 would be required. To allow for dropout rates, the study will target a sample size of 27 participants.

The data analysis will be done in consultation with an independent statistician. The full dataset, comprising all participants, will be submitted to the statistician for analysis. The data analysis will focus on descriptive statistics and confidence intervals for the variables we are obtaining. The characteristics of the sample will also be described. Descriptive statistics will be reported as mean, median, standard deviations, frequencies and proportions. Graphical representations will be made where applicable to assist in visualizing aspects of the data. Furthermore, if the recruited sample and collected data allow, the data analysis will include inferential statistics on the changes between the pre-test and post-test outcomes to report on clinical test results. Participants who completed less than 75% of intervention sessions (less than six out of eight BST sessions), will be excluded from data analysis. Paired t-tests will be performed to determine changes in values between baseline and post-intervention mobility outcome measures, a P value of 5% will be seen as statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2022
Actual
8/02/2022
Date of last participant enrolment
Anticipated
29/08/2022
Actual
23/06/2022
Date of last data collection
Anticipated
29/09/2022
Actual
20/07/2022
Sample size
Target
27
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 23711 0
New Zealand
State/province [1] 23711 0
Auckland

Funding & Sponsors
Funding source category [1] 308631 0
Self funded/Unfunded
Name [1] 308631 0
Izel Gilfillan
Country [1] 308631 0
New Zealand
Funding source category [2] 309072 0
Other
Name [2] 309072 0
ABI Rehabilitation
Country [2] 309072 0
New Zealand
Funding source category [3] 309073 0
Other
Name [3] 309073 0
HQH Fitness
Country [3] 309073 0
New Zealand
Primary sponsor type
Individual
Name
Izel Gilfillan
Address
ABI Rehabilitation
180 Metcalfe Road
Ranui
Auckland
0612
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309499 0
Individual
Name [1] 309499 0
Mrs A van Heerden
Address [1] 309499 0
Faculty of Health Sciences
Department of Physiotherapy
Room3-75.11, Level 3, HW Snyman North Building
University of Pretoria
Private Bag X323
Gezina
Pretoria
0031
South Africa
Country [1] 309499 0
South Africa

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308345 0
School of Health Sciences Research Ethics Committee, University of Pretoria
Ethics committee address [1] 308345 0
Ethics committee country [1] 308345 0
South Africa
Date submitted for ethics approval [1] 308345 0
24/06/2021
Approval date [1] 308345 0
29/07/2021
Ethics approval number [1] 308345 0
399/2021
Ethics committee name [2] 308558 0
Health and Disability Ethics Committee
Ethics committee address [2] 308558 0
Ethics committee country [2] 308558 0
New Zealand
Date submitted for ethics approval [2] 308558 0
01/07/2021
Approval date [2] 308558 0
26/01/2022
Ethics approval number [2] 308558 0
21/CEN/238

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

Contacts
Principal investigator
Name 110386 0
Mrs Izel Gilfillan
Address 110386 0
ABI Rehabilitation
180 Metcalfe Road
Ranui
Auckland
0612
New Zealand
Country 110386 0
New Zealand
Phone 110386 0
+64 09 8310070
Fax 110386 0
Email 110386 0
[email protected]
Contact person for public queries
Name 110387 0
Izel Gilfillan
Address 110387 0
ABI Rehabilitation
180 Metcalfe Road
Ranui
Auckland
0612
New Zealand
Country 110387 0
New Zealand
Phone 110387 0
+64 09 8310070
Fax 110387 0
Email 110387 0
[email protected]
Contact person for scientific queries
Name 110388 0
Izel Gilfillan
Address 110388 0
ABI Rehabilitation
180 Metcalfe Road
Ranui
Auckland
0612
New Zealand
Country 110388 0
New Zealand
Phone 110388 0
+64 09 8310070
Fax 110388 0
Email 110388 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
Participants’ privacy and anonymity will be ensured. Their individual data will not be published in the final article or throughout the research. All information gathered will be de-identified and kept confidential.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11978Study protocol  [email protected]



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.