Ballistic Strength Training in Stroke: A Pilot Study
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Ballistic Strength Training
Usual Care Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Alfred Health - Caulfield Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Ballistic Strength Training
Usual care Physiotherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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).
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.
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.
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.
Full Information
NCT ID
NCT01958736
First Posted
October 7, 2013
Last Updated
October 17, 2016
Sponsor
Bayside Health
Collaborators
Australian Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT01958736
Brief Title
Ballistic Strength Training in Stroke: A Pilot Study
Official Title
Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayside Health
Collaborators
Australian Catholic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Ballistic Strength Training
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual care Physiotherapy
Intervention Type
Other
Intervention Name(s)
Ballistic Strength Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
10 metre walk test comfortable pace
Description
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
Title
10 metre walk test, maximum safe pace
Description
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
Title
High level mobility assessment tool (HiMAT)
Description
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
Title
Timed up and go test (TUG)
Description
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
Title
Functional Ambulation Category (FAC)
Description
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
Title
Assessment of quality of life 4D
Description
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.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genevieve C Hendrey, B Phys (Hons)
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne E Holland, PhD
Organizational Affiliation
Alfred Health and La Trobe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gavin Williams, PhD
Organizational Affiliation
Epworth Healthcare, Melbourne University, La Trobe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ross Clark, PhD
Organizational Affiliation
Australian Catholic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Health - Caulfield Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3162
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
29859180
Citation
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.
Results Reference
derived
Learn more about this trial
Ballistic Strength Training in Stroke: A Pilot Study
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