StrokeNCT01958736
Ballistic Strength Training in Stroke: A Pilot Study
A study testing Ballistic Strength Training in people with Stroke, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Ballistic Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Alfred Health - Caulfield Hospital
Melbourne, Victoria, 3162
About this study
Official title: Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
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.
Read the detailed description
Research Aims:
- To establish the feasibility of ballistic strength training in stroke and
- To evaluate the effects of ballistic strength training exercises on mobility outcomes, strength and quality of life when compared with usual care.
Methods:
This wil be a prospective, randomized, controlled, assessor-blinded pilot study. It will be conducted 3 x per week for 6 weeks (i.e. a total of 18 sessions lasting 30 minutes).
Primary outcome measure: Feasibility
- Recruitment
- Retention/Attrition
- Clinical Feasibility
- Safety
Secondary outcome measures - measured at baseline and completion
- Ten metre walk test (10MWT) comfortable pace
- 10MWT maximum safe pace
- High level mobility assessment tool (HiMAT): Only in participants where 10MWT is <12.5s at baseline
- Timed up and go test (TUG)
- Functional Ambulation Category (FAC)
- Health Related Quality of Life (HRQoL) via AQoL-4D
Description of intervention:
Control Group:
The control 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
Experimental group:
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.
- Conditions
- Stroke
- Being tested
- Ballistic Strength Training, Usual Care Physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballistic Strength TrainingOther
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.
Usual Care PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Ballistic Strength Training Receives: Other: Ballistic Strength Training |
| Control | Active comparator | Usual care Physiotherapy Receives: Other: Usual Care Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
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
Measured: 6 weeks
Secondary outcomes (6)
10 metre walk test comfortable pace
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.
Measured: Baseline and 6 weeks
10 metre walk test, maximum safe pace
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.
Measured: Baseline and 6 weeks
High level mobility assessment tool (HiMAT)
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).
Measured: Baseline and 6 weeks
Timed up and go test (TUG)
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.
Measured: Baseline and 6 weeks
Functional Ambulation Category (FAC)
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.
Measured: Baseline and 6 weeks
Assessment of quality of life 4D
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Australian Catholic University
- Responsible party
- Principal investigator, Ms. Rowan Frew, Bayside Health
- Investigators
- Genevieve C Hendrey, B Phys (Hons), Principal investigator, The AlfredAnne E Holland, PhD, Principal investigator, Alfred Health and La Trobe UniversityGavin Williams, PhD, Principal investigator, Epworth Healthcare, Melbourne University, La Trobe UniversityRoss Clark, PhD, Principal investigator, Australian Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958736
- Sponsor's protocol ID
- 369/13
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2013
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hendrey G, Clark RA, Holland AE, Mentiplay BF, Davis C, Windfeld-Lund C, Raymond MJ, Williams G. Feasibility of Ballistic Strength Training in Subacute Stroke: A Randomized, Controlled, Assessor-Blinded Pilot Study. Arch Phys Med Rehabil. 2018 Dec;99(12):2430-2446. doi: 10.1016/j.apmr.2018.04.032. Epub 2018 May 30.
PubMed 29859180
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT01958736
- Acronym / sponsor ID
- 369/13
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Australian Catholic University
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Aims:
- To establish the feasibility of ballistic strength training in stroke and
- To evaluate the effects of ballistic strength training exercises on mobility outcomes, strength and quality of life when compared with usual care.
Methods:
This wil be a prospective, randomized, controlled, assessor-blinded pilot study. It will be conducted 3 x per week for 6 weeks (i.e. a total of 18 sessions lasting 30 minutes).
Primary outcome measure: Feasibility
- Recruitment
- Retention/Attrition
- Clinical Feasibility
- Safety
Secondary outcome measures - measured at baseline and completion
- Ten metre walk test (10MWT) comfortable pace
- 10MWT maximum safe pace
- High level mobility assessment tool (HiMAT): Only in participants where 10MWT is <12.5s at baseline
- Timed up and go test (TUG)
- Functional Ambulation Category (FAC)
- Health Related Quality of Life (HRQoL) via AQoL-4D
Description of intervention:
Control Group:
The control 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
Experimental group:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Ballistic Strength TrainingBallistic Strength Training |
| Control | Active comparator | Other: Usual Care PhysiotherapyUsual care Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ballistic Strength TrainingThe 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 | Experimental |
| Usual Care PhysiotherapyThis 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. | Other | Control |
Primary outcome
Feasibility
Time frame: 6 weeks
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
6 secondary outcomes
10 metre walk test comfortable pace
Time frame: Baseline and 6 weeks
10 metre walk test, maximum safe pace
Time frame: Baseline and 6 weeks
High level mobility assessment tool (HiMAT)
Time frame: Baseline and 6 weeks
Timed up and go test (TUG)
Time frame: Baseline and 6 weeks
Functional Ambulation Category (FAC)
Time frame: Baseline and 6 weeks
Assessment of quality of life 4D
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Derived from this study: PubMed 29859180Hendrey G, Clark RA, Holland AE, Mentiplay BF, Davis C, Windfeld-Lund C, Raymond MJ, Williams G. Feasibility of Ballistic Strength Training in Subacute Stroke: A Randomized, Controlled, Assessor-Blinded Pilot Study. Arch Phys Med Rehabil. 2018 Dec;99(12):2430-2446. doi: 10.1016/j.apmr.2018.04.032. Epub 2018 May 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve C Hendrey, B Phys (Hons) principal investigator
The Alfred
Anne E Holland, PhD principal investigator
Alfred Health and La Trobe University
Gavin Williams, PhD principal investigator
Epworth Healthcare, Melbourne University, La Trobe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballistic Strength Training in people with Stroke, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016; AzTrials last refreshed its copy on 3 Nov 2026.