Contact information
Type
Scientific
Primary contact
Dr Jane Cross
ORCID ID
Contact details
School AHP
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
j.cross@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TSA 2008/08
Study information
Scientific title
Functional strength training to improve walking and upper limb function in people at least one year after stroke: a phase II trial
Acronym
Study hypothesis
The hypothesis is that providing functional strength training (FST) to people who are at least one year after stroke will improve motor function and ability to perform everyday functional activity. The first step towards testing this hypothesis in a definitive phase III clinical trial is to address the following questions:
1. Is there sufficient efficacy to justify subsequent trials of FST for upper and lower limb motor recovery in people at least one year after stroke?
2. Is FST delivered in the community acceptable to stroke survivors one year and more after stroke?
3. What is the probable recruitment rate to a subsequent phase III trial?
4. What sample size is needed for subsequent phase III trial (effect size, attrition rate, response variation)?
5. What cost-effectiveness data should be collected in subsequent trials?
Ethics approval
Norfolk Ethics Committee approval pending as of 12/01/2009
Study design
Randomised placebo-controlled observer-blind phase II trial with embedded qualitative investigation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke
Intervention
Functional strength training is hands-off progressive resistive exercise during functional activity whilst directing participants attention to the activity being performed and providing appropriate verbal feedback to enhance knowledge of performance. FST is designed to increase ability to produce voluntary muscle force throughout joint range, increase ability to modulate force in muscles/muscle groups appropriate for the activity being trained and improve functional ability. Activities are progressed by increasing the number of repetitions, increasing range of joint motion required and increasing the load to be moved. Intervention will be provided by a Research Physiotherapist for 1 hour/day, 4 days/week. Portable equipment (e.g. free weights and steppers) will be used as appropriate. Participants will be encouraged to use the paretic limb (upper or lower as allocated) in everyday functional activity. Standardised treatment schedules will be used (as in our earlier trials) to record the amount and type of intervention provided (compliance).
FSTLL will focus on functional activities e.g. sit-to-stand using body weight as resistance and progressively lowering the height of the supporting surface as participants improve. Equipment such as portable steppers will be used as appropriate but only with physiotherapy supervision for safety reasons.
FSTUL will focus on reaching for, retrieval of and manipulation (use) of everyday objects for activities such as pouring water from a jug, opening jars and lacing a shoe.
Both treatment schedules will include resistive exercise to strengthen specific muscles/muscle groups where weakness is hampering functional activity. The scientific papers describing these treatment schedules are currently in preparation.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
1. Functional Ambulatory Category for lower limb function
2. Action Research Arm Test for upper limb function
All measured on days 43 and 88.
Secondary outcome measures
1. Modified Rivermead Mobility Index for lower limb function
2. Nine Hole Peg Test for upper limb function
All measured on days 43 and 88.
Overall trial start date
01/03/2009
Overall trial end date
01/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults aged 18 years and above, either sex, one to five years after stroke in anterior circulation (infarct or haemorrhage) not receiving formal therapy for their upper or lower limb
2. Have a walking ability on the Functional Ambulatory Category between 1 and 49 and have some voluntary activity in the paretic upper limb scoring 12+/57 on the Action Research Arm Test but unable to complete the Nine Hole Peg Test in 50 seconds or less
3. Can follow a one-stage command, i.e. sufficient communication/orientation for interventions in this trial
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
58
Participant exclusion criteria
Known pathology precluding them participating in functional strength training
Recruitment start date
01/03/2009
Recruitment end date
01/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School AHP
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
The Stroke Association (UK)
Sponsor details
Stroke House
240 City Road
London
EC1V 2PR
United Kingdom
research@stroke.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Stroke Association (UK) (ref: TSA 2008/08)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22510162
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25118156
Publication citations
-
Protocol
Mares K, Cross J, Clark A, Barton GR, Poland F, O'Driscoll ML, Watson MJ, McGlashan K, Myint PK, Pomeroy VM, The FeSTivaLS trial protocol: a randomized evaluation of the efficacy of functional strength training on enhancing walking and upper limb function later post stroke., Int J Stroke, 2013, 8, 5, 374-382, doi: 10.1111/j.1747-4949.2012.00778.x.
-
Results
Mares K, Cross J, Clark A, Vaughan S, Barton GR, Poland F, McGlashan K, Watson M, Myint PK, O'Driscoll ML, Pomeroy VM, Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial., Trials, 2014, 15, 322, doi: 10.1186/1745-6215-15-322.