Condition category
Circulatory System
Date applied
12/01/2009
Date assigned
30/01/2009
Last edited
15/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.stroke.org.uk/

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22510162
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25118156

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes