Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000460000
Ethics application status
Not yet submitted
Date submitted
1/06/2010
Date registered
4/06/2010
Date last updated
4/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Strength for Task Training’ to improve walking following stroke.
Scientific title
'Strength for Task Training’ to optimise locomotor function following stroke: A pilot randomised controlled trial.
Secondary ID [1] 251917 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 257499 0
Condition category
Condition code
Stroke 257679 257679 0 0
Ischaemic
Stroke 257680 257680 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strength for Task Training
Administered 3-9 months post- first stroke
Group exercise 5 participants : 1 physiotherapist and 1 therapy assistant
High intensity progressive resistance strength training of a prime mover immediately followed by motor skill training of a relevant motor skill task.
Frequency: 3 times per week, 1 hour per session
Duration: 12 weeks
Intensity: 50-80% 1 Repetition Maximum and at 'somewhat hard'
Intervention code [1] 256593 0
Rehabilitation
Comparator / control treatment
1) Progressive Resistance Strength Training
Administered 3-9 months post- first stroke
Group exercise 5 participants : 1 physiotherapist and 1 therapy assistant
High intensity progressive resistance strength training Frequency: 3 times per week, 1 hour per session
Duration: 12 weeks
Intensity: 50-80% 1RM

2) Motor Skill Training
Administered 3-9 months post- first stroke
Group exercise 5 participants : 1 physiotherapist and 1 therapy assistant
High intensity motor skill training of relevant locomotor skills.
Frequency: 3 times per week, 1 hour per session
Duration: 12 weeks
Intensity: 'somewhat hard' as rated by the participant

3) Usual Care Control
3-9 months post- first stroke
No attempt to control the type or amount of rehabilitation recieved. Therapy specifics documented using previously tested methods.
Control group
Active

Outcomes
Primary outcome [1] 258560 0
Neural Plasticity: Cortical excitability using Transcranial Magnetic Stimulation (TMS) of the soleus muscle at 10% Maximal Voluntary Contraction to measure Active Motor Threshold, Motor Evoked Potential, Intra cortical Inhibition and Intra cortical facillitation, Input/Output curves and during the push off phase of gait to measure task specific Motor Evoked Potential, Intra cortical Inhibition and Intra cortical facillitation
Timepoint [1] 258560 0
Baseline
Post-intervention (12 weeks)
Primary outcome [2] 258561 0
Locomotor Function measured using comfortable and fast paced gait velocity, stair ascend and descend, 30second chair stand test and the step test
Timepoint [2] 258561 0
Baseline
Post-intervention (12 weeks)
Primary outcome [3] 258562 0
Participation using the Subjective Index of Physical and Social Outcome and the Stroke Impact Scale
Timepoint [3] 258562 0
Baseline
Post-intervention (12 weeks)
Secondary outcome [1] 264421 0
Recruitment numbers including the number of approached, screened and consented individuals over the recruitment phase
Timepoint [1] 264421 0
Post-intervention (12 weeks)
Secondary outcome [2] 264473 0
Randomised Controlled Trial Protocol Integrity including the number of completed versus scheduled intervention sessions, the number of exercise progressions over the intervention and the number of missing data points
Timepoint [2] 264473 0
Post-intervention (12 weeks)
Secondary outcome [3] 264474 0
Intervention acceptability including the barriers and facillitators to engaging in the rehabilitation intervention, the acceptability of the intervention and the perceived cost-benefit using semi-structured interviews
Timepoint [3] 264474 0
Post-intervention (12 weeks)
Secondary outcome [4] 264479 0
Muscle Strength measured using 1 Repetition Maximum leg press
Timepoint [4] 264479 0
Baseline
Post-intervention (12 weeks)
Secondary outcome [5] 264480 0
Neural Plasticity: Brain Derived Neurotrophic Factor (BDNF) measured pre, during and post a bout of submaximal exercise using blood serum levels established via Enzyme-linked immunosorbent assay (ELISA) kits
Timepoint [5] 264480 0
Baseline
Post-intervention (12 weeks)

Eligibility
Key inclusion criteria
All people aged over 18 years with a single disabling supratentorial ischaemic stroke or intracerebral haemorrhage (Rankin 2-3); between 3-9 months post stroke at the start of the intervention; with a gait speed of between 0.05m/s -<1.2m/s at entry to the study; who are able to walk with or without aid and with or without standby assistance will be eligible for recruitment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded if: (a) their behaviour would interfere with participation in a group setting, as noted during initial assessment (e.g., agitation, aggression); (b) they have a significant cognitive deficit ((Mini-Mental State Examination (MMSE) Score <23); (c)they are unable to follow a 1 step English verbal command; (d) they are unable to give informed consent; (e) they are medically unstable in the opinion of a medical clinician; (f) they are participating in another study that, in the opinion of the investigator, may affect gait speed or add significantly to participant’s burden; (g) they have excessive pain in any joint that could limit participation; or (h) they have another condition that could impact results (e.g., substance abuse, significant mental illnesses such as major depression) (i) they have any contra-indications to TMS, including pacemaker, artificial heart valves, other metal implants, pregnancy, skull abnormalities, history of seizures or epilepsy, taking medications that may lower seizure threshold, or claustrophobia.

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)
Potentially eligible stroke survivors will be approached via the Stroke Clinics of the Waitemata District Health Boards (DHB). Additional participants may be sourced from the Stroke Foundation, and directly from the community via newspaper advertisement. A research assistant will liaise with clinical staff and screen hospital databases, where available, to identify potential participants. The study research assistant will send an information sheet to all potential participants explaining the study and asking them if they would like to participate in the study. About one week later all potential participants will be contacted by telephone (or letter, where telephone is unavailable) to answer any questions and ascertain the persons willingness to participate.
Once the project team are notified of potential participants, informed written consent will be sought. Only people who meet the eligibility criteria and provide written informed consent will be included. Once initial assessment is completed by a blinded assesor, participants will be randomly assigned to either the Strength for Task Training (STT), Progressive Resisted Strength Training (PRST), Motor Skill Training (MST), or Usual Care Control (UCC) group. Randomisation will be concealed using an on-line randomisation service based at the School of Rehabilitation and Occupation Studies, AUT University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised participants will receive the intervention once a group of 5 participants has accrued. Randomisation will be concealed using an on-line randomisation service based at the School of Rehabilitation and Occupation Studies, AUT University.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This mixed method study will involve a randomised controlled pilot trial design with four intervention groups to investigate the effect of STT on participation, locomotor function and neural plasticity in twenty people aged over 18 years with a single stroke and to consider the feasibility of the research protocol for a larger randomised controlled trial.
Outcome measures of participation, locomotor function and neural plasticity, and semi-structured interviews to explore the feasibility and acceptability of the intervention, will be conducted prior to and post intervention. In addition the success of the sampling and recruitment strategy and the integrity of the trial protocol will be monitored using specific markers of success.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2676 0
New Zealand
State/province [1] 2676 0
Auckland

Funding & Sponsors
Funding source category [1] 257085 0
Government body
Name [1] 257085 0
Strategy to Advance Research Grant (STAR Grant) from Tertiary Education Commission's Building Research Capability in Strategically Relevant Areas (BRCSRA) fund
Country [1] 257085 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
School of Rehabilitation and Occupation Studies
AUT University
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 256343 0
None
Name [1] 256343 0
N/A
Address [1] 256343 0
N/A
Country [1] 256343 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259111 0
Ethics committee address [1] 259111 0
Ethics committee country [1] 259111 0
Date submitted for ethics approval [1] 259111 0
15/06/2010
Approval date [1] 259111 0
Ethics approval number [1] 259111 0

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

Contacts
Principal investigator
Name 31246 0
Address 31246 0
Country 31246 0
Phone 31246 0
Fax 31246 0
Email 31246 0
Contact person for public queries
Name 14493 0
Nada Signal
Address 14493 0
School of Rehabilitation and Occupation Studies
AUT University
Private Bag 92006
Auckland 1142
Country 14493 0
New Zealand
Phone 14493 0
+64 9 9219999 extn 7062
Fax 14493 0
Email 14493 0
[email protected]
Contact person for scientific queries
Name 5421 0
Nada Signal
Address 5421 0
School of Rehabilitation and Occupation Studies
AUT University
Private Bag 92006
Auckland 1142
Country 5421 0
New Zealand
Phone 5421 0
+64 9 9219999 extn 7062
Fax 5421 0
Email 5421 0
[email protected]

No information has been provided regarding IPD availability


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.