Functional strength training to improve walking and upper limb function in stroke patients
| ISRCTN | ISRCTN71632550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71632550 |
| Secondary identifying numbers | 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
Scientific
School AHP
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| j.cross@uea.ac.uk |
Study information
| Study design | Randomised placebo-controlled observer-blind phase II trial with embedded qualitative investigation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2009 |
| Completion date | 01/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
School AHP
Norwich
NR4 7TJ
United Kingdom
NR4 7TJ
United Kingdom
Sponsor information
The Stroke Association (UK)
Charity
Charity
Stroke House
240 City Road
London
EC1V 2PR
United Kingdom
| research@stroke.org.uk | |
| Website | http://www.stroke.org.uk/ |
"ROR" |
https://ror.org/05mgfq941 |
Funders
Funder type
Charity
The Stroke Association (UK) (ref: TSA 2008/08)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2013 | Yes | No | |
| Results article | results | 12/08/2014 | Yes | No |
