Functional strength training to improve walking and upper limb function in stroke patients

ISRCTN	ISRCTN71632550
DOI	https://doi.org/10.1186/ISRCTN71632550
Protocol serial number	TSA 2008/08
Sponsor	The Stroke Association (UK)
Funder	The Stroke Association (UK) (ref: TSA 2008/08)

Submission date: 12/01/2009
Registration date: 30/01/2009
Last edited: 15/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jane Cross
Scientific

School AHP
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Email	j.cross@uea.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised placebo-controlled observer-blind phase II trial with embedded qualitative investigation
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Functional strength training to improve walking and upper limb function in people at least one year after stroke: a phase II trial
Study objectives	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(s)	Norfolk Ethics Committee approval pending as of 12/01/2009
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Functional Ambulatory Category for lower limb function 2. Action Research Arm Test for upper limb function All measured on days 43 and 88.
Key secondary outcome measure(s)	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.
Completion date	01/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	58
Key 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
Key exclusion criteria	Known pathology precluding them participating in functional strength training
Date of first enrolment	01/03/2009
Date of final enrolment	01/03/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School AHP

Norwich
NR4 7TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/08/2014		Yes	No
Protocol article	protocol	01/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes