Alfred Health - Caulfield Hospital
Melbourne, Victoria, 3162, Australia
NCT Number: NCT01958736
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Melbourne, Victoria, 3162, Australia
Research Aims:
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
Secondary outcome measures - measured at baseline and completion
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
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.
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.
Time frame: 6 weeks
Recruitment:
Retention/Attrition:
Clinical feasibility
Safety
Time frame: Baseline and 6 weeks
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.
Time frame: Baseline and 6 weeks
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.
Time frame: Baseline and 6 weeks
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).
Time frame: Baseline and 6 weeks
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.
Time frame: Baseline and 6 weeks
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.
Time frame: Baseline and 6 weeks
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.
Bayside Health
Other Gov
Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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