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Trial registered on ANZCTR


Registration number
ACTRN12625000139471p
Ethics application status
Submitted, not yet approved
Date submitted
18/01/2025
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does task-specific strength training improve mobility after stroke?
Scientific title
Effect of task-specific (power) strength training on mobility in patients undergoing inpatient rehabilitation within 3 months following stroke
Secondary ID [1] 313727 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
The pilot trial examined the safety and feasibility of task-specific (power) strength training on mobility in patients following stroke, and provided the data for sample size calculations for the RCT.
Feasibility of Ballistic Strength Training in Subacute Stroke: A Randomized, Controlled, Assessor-Blinded Pilot Study. G. Hendrey et al. Archives of Physical Medicine and Rehabilitation 2018 Vol. 99 Issue 12 Pages 2430-2446. doi.org/10.1016/j.apmr.2018.04.032

Health condition
Health condition(s) or problem(s) studied:
Stroke 336330 0
Condition category
Condition code
Stroke 332869 332869 0 0
Ischaemic
Physical Medicine / Rehabilitation 332972 332972 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, multi-centre, randomised, single-blind trial of a 6-week program, conducted for 1 hour, 3 times per week (a total of 18 sessions) during the sub-acute phase of rehabilitation (< 3 months) which is the optimal period for recovery from stroke, with 20 week follow-up. Participants will be recruited from Epworth Healthcare, and the intervention will be either hospital or home-based for out-patients, depending on patient preference.
Intervention group
Participants will perform task-specific (power) resistance training tailored to the severity of their muscle paresis and performed according to the American College of Sports Medicine guidelines to ensure an optimal training stimulus and transfer of training gains. During normal walking, the joints have to move quickly, which means the leg muscles have to generate force quickly. Muscle power is the rate at which force is generated. Power training prioritizes the rate of force production compared to traditional strength training which has focused on slow-speed, high resistance exercises to maximize force production. Power training is task-specific for the muscles that provide power generation for forward propulsion when walking.

Task-specific (power) resistance training will focus on three main areas. First, the three key muscle groups responsible for forward propulsion (the ankle plantar-flexors, hip extensors and hip flexors) and faster walking speeds will be targeted. Second, a protocol for exercise progression has been included, ensuring the participants perform power training correctly, quantified by the rate of force development measured using a string potentiometer whilst supervised by a trained research assistant. Supervision is vital for safe and accurate power training implementation. Initial loads will be low to facilitate high contraction velocities for power training. Third, specific power training exercises will be performed in the range through which the muscle is active when walking. When participants can consistently perform power training at the required speed (for example, approaching 300°/s at the ankle joint), the load will be progressively increased. Examples of power training exercises used in the pilot RCT and large traumatic brain injury trial include;
1) calf hops on a ‘leg sled’ (targeting ankle plantar-flexors)
2) reciprocal leg extension on a mini-trampet (mini-trampoline, targeting ankle plantar-flexors)
3) step and stair descent (targeting the loading response phase and terminal stance)
4) fast cyclical hip and knee flexion in standing (targeting hip flexors)
5) As per 4 with additional resistance (targeting hip extensors)
6) Fast walking to translate training gains from power training into walking.

Standard principles governing frequency, duration, intensity, repetitions, rest periods and progression of resistance exercises will be applied in order to ensure an optimal training stimulus. Power training has very few adverse events reported for people with neurological conditions, and no adverse events were associated with the intervention in our pilot trial.

Both Groups
The majority of participants will commence the trial during the inpatient phase of rehabilitation where they receive multi-disciplinary therapy (including physiotherapy, occupational and speech therapy). Physiotherapy is typically provided twice daily on weekdays (i.e. 10 sessions/week). Physiotherapy for stroke usually comprises balance training, stretching, cardiovascular fitness training and traditional resistance training.34, 35 It also includes walking tasks that are important for community mobility (e.g. walking indoors and outdoors, negotiating slopes, uneven surfaces and gutters). Participants in both groups will continue to receive typical physiotherapy provided after stroke for seven sessions/week. Participants randomised to the Experimental Group will replace three sessions of physiotherapy with task-specific (power) resistance training and fast walking each week, and participants randomised to the Control Group will replace three sessions of physiotherapy with traditional resistance training and community walking.

In order to ensure the exercises in each group are conducted according to the training protocols, a trained physiotherapist or exercise physiologist will supervise every session for each participant. Sessions will be administered individually (i.e. 1:1). Attendance will be recorded, and time spent performing each exercise in each group will be documented. In order for participants to have satisfactorily completed the trial = 80% of sessions (15 sessions) must be completed.

The pilot RCT was registered on clinicaltrials.gov: NCT01958736.
Intervention code [1] 330323 0
Rehabilitation
Comparator / control treatment
Control group/usual care participants will attend 1 hour sessions, 3 times per week for 6-weeks (a total of 18 sessions). In order to ensure the exercises in each group are conducted according to the training protocols, a trained physiotherapist or exercise physiologist will supervise every session for each participant. Sessions will be administered individually (i.e. 1:1). Participants will be recruited from Epworth Healthcare, and the intervention will be either hospital or home-based for out-patients, depending on patient preference.

Usual care
Participants will perform traditional slow-speed high resistance leg exercises, also tailored to the severity of their muscle paresis and performed according to the American College of Sports Medicine guidelines for muscle strength training in addition to usual care rehabilitation. Traditional slow-speed resistance training typically comprises leg curls, calf raises, squats, calf raises and hip abduction. Participants in the Control Group will also practice walking (outside, over varying slopes and surfaces, gutters).

Both Groups
The majority of participants will commence the trial during the inpatient phase of rehabilitation where they receive multi-disciplinary therapy (including physiotherapy, occupational and speech therapy). Physiotherapy is typically provided twice daily on weekdays (i.e. 10 sessions/week). Physiotherapy for stroke usually comprises balance training, stretching, cardiovascular fitness training and traditional resistance training. It also includes walking tasks that are important for community mobility (e.g. walking indoors and outdoors, negotiating slopes, uneven surfaces and gutters). Participants in both groups will continue to receive typical physiotherapy provided after stroke for seven sessions/week. Participants randomised to the Experimental Group will replace three sessions of physiotherapy with task-specific (power) resistance training and fast walking each week, and participants randomised to the Control Group will replace three sessions of physiotherapy with traditional resistance training and community walking.
Control group
Active

Outcomes
Primary outcome [1] 340392 0
Mobility
Timepoint [1] 340392 0
Week 0, 6 (primary endpoint) and 26 (post-commencement of intervention).
Secondary outcome [1] 443939 0
Muscle strength
Timepoint [1] 443939 0
Week 0, 6 and 26 (post-commencement of intervention).
Secondary outcome [2] 443940 0
Muscle power generation - hip flexors
Timepoint [2] 443940 0
Week 0, 6 and 26 (post-commencement of intervention).
Secondary outcome [3] 443941 0
Physical Activity
Timepoint [3] 443941 0
Week 0, 6 and 26 (post-commencement of intervention).
Secondary outcome [4] 443942 0
Participation
Timepoint [4] 443942 0
Week 0, 6 and 26 (post-commencement of intervention).
Secondary outcome [5] 443943 0
Health Related Quality of Life (HRQoL)
Timepoint [5] 443943 0
Week 0, 6 and 26 (post-commencement of intervention).
Secondary outcome [6] 444306 0
Muscle power generation - hip extensors
Timepoint [6] 444306 0
Week 0, 6 and 26 (post-commencement of intervention).
Secondary outcome [7] 444307 0
Muscle power generation - calf
Timepoint [7] 444307 0
Week 0, 6 and 26 (post-commencement of intervention).

Eligibility
Key inclusion criteria
• have been admitted for inpatient rehabilitation following stroke
• are greater than or equal to 18 years of age
• are less than or equal to 3 months after their first stroke
• have lower limb weakness determined by a one-repetition maximum (i.e. 1RM leg press < intact leg)
• can walk 14 metres unaided with a walking speed of > 0.4 and < 1.2 m/s (i.e. no physical contact assistance).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• are unable to provide informed consent (determined by the rehabilitation consultant)
• have a concurrent medical condition that prevents participation in a stroke rehabilitation program or affects their ability to walk (e.g. unstable cardiac condition or severe arthritis).

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)
Yes - sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted blocks of randomly varying length
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
2/06/2029
Actual
Date of last data collection
Anticipated
2/12/2029
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27499 0
Epworth Richmond - Richmond
Recruitment hospital [2] 27500 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 43610 0
3121 - Richmond
Recruitment postcode(s) [2] 43611 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 318194 0
Self funded/Unfunded
Name [1] 318194 0
Country [1] 318194 0
Primary sponsor type
Hospital
Name
Epworth Healthcare
Address
Country
Australia
Secondary sponsor category [1] 320594 0
None
Name [1] 320594 0
Address [1] 320594 0
Country [1] 320594 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316845 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316845 0
Ethics committee country [1] 316845 0
Australia
Date submitted for ethics approval [1] 316845 0
20/01/2025
Approval date [1] 316845 0
Ethics approval number [1] 316845 0

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

Contacts
Principal investigator
Name 139178 0
Prof Gavin Williams
Address 139178 0
Physiotherapy Dept, Epworth Healthcare, 89 Bridge Rd, Richmond, Victoria 3121
Country 139178 0
Australia
Phone 139178 0
+61 400019386
Fax 139178 0
Email 139178 0
gavin.williams@epworth.org.au
Contact person for public queries
Name 139179 0
Gavin Williams
Address 139179 0
Physiotherapy Dept, Epworth Healthcare, 89 Bridge Rd, Richmond, Victoria 3121
Country 139179 0
Australia
Phone 139179 0
+61 400019386
Fax 139179 0
Email 139179 0
gavin.williams@epworth.org.au
Contact person for scientific queries
Name 139180 0
Gavin Williams
Address 139180 0
Physiotherapy Dept, Epworth Healthcare, 89 Bridge Rd, Richmond, Victoria 3121
Country 139180 0
Australia
Phone 139180 0
+61 400019386
Fax 139180 0
Email 139180 0
gavin.williams@epworth.org.au

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?

No Supporting Document Provided



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.