StrokePhase 2NCT00322192
Evaluation of Whether Functional Strength Training Can Enhance Recovery of Mobility After Stroke
A Phase 2 study testing Conventional UK Physical therapy, Increased intensity of UK conventional physical therapy and UK conventional physical therapy plus functional strength training in people with Stroke, run by St George's, University of London at 4 sites in United Kingdom.
Trial summary
The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional UK Physical therapy, Increased intensity of UK conventional physical therapy and UK conventional physical therapy plus functional strength training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jan 2004to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects in this study will:
- be aged over 50 years.
- be between one week and three months after stroke when recruited to the study;
- have been independently mobile indoors, with or without aids, before the stroke;
- have some voluntary movement in the paretic lower limb i.e. score above 28/100 on the lower limb section of the Motricity Index43;
- demonstrate adequate orientation and communication (be able to complete a one-stage command using the non-paretic upper limb e.g. point at the ceiling).
- In addition those who agree to participate in TMS measurement will have no contraindications to TMS.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Epsom and St Helier NHS Trust
Carshalton, Surrey, SM5 1AA
Ashford and St Peter's Hospitals NHS Trust
Chertsey, Surrey, KT16 0PZ
St George's Hospital NHS Trust
London, London, SW17 0RE
Mayday University Hospital NHS Trust
Thornton Heath, Surrey, CR7 7YE
About this study
Official title: The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke
The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy
Read the detailed description
Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.
An observer-blind randomised clinical trial. Subjects will be within 3 months of first stroke with some voluntary movement in the paretic lower limb. A power calculation estimated the sample size as 300. Research Physiotherapists, blinded to measurement, will recruit subjects, allocate subjects to one of the three intervention groups using sequentially numbered sealed envelopes containing previously randomised allocated intervention cards and provide interventions. The Research Assessors, blinded to intervention allocation will undertake all measurements. Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1) or functional strength training (experimental 2) will be provided for one hour, four times a week, for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting. Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are maximum torque around the knee joint, and gait velocity. The secondary outcomes include movement analysis, functional ability, corticospinal transmission (transcranial magnetic stimulation) and health related quality of life (Euroqol). The primary analysis will be analysis of covariance. A multiple comparison procedure (Gabriel's test) will be used to compare each pair of treatments. Euroqol data will be used to estimate the relative costs of the interventions and to calculate the incremental cost per QUALY gained. Every effort will be made to invite patients for assessment at outcome and follow-up even if they have withdrawn from therapy to allow the intention-to-treat principle to be applied.
- Conditions
- Stroke
- Being tested
- Conventional UK Physical therapy, Increased intensity of UK conventional physical therapy, UK conventional physical therapy plus functional strength training
- Keywords
- Stroke rehabilitation, Physical Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional UK Physical therapyBehavioural
Increased intensity of UK conventional physical therapyBehavioural
UK conventional physical therapy plus functional strength trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum torque around the knee joint
gait velocity
Secondary outcomes (7)
Modified Rivermead Mobility Index
Lower limb kinematics during standing up
Lower limb kinematics during sitting down
Lower limb kinematics during walking
timing and pattern of muscle activation during functional activity
EuroQuol for health related quality of life
Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2006 (estimated)
- Study startJan 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- The Health Foundation
- Investigators
- Valerie M Pomeroy, PhD, Study chair, St George's University London, UKEmma V Cooke, MSc, Principal investigator, St George's University London, UKRaymond C Tallis, FMedSci, Study director, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322192
- Sponsor's protocol ID
- Health Foundation 224/1960
- Other IDs
- Health Foundation 224/1960
- Status last verified
- May 2006
- First submitted
- 4 May 2006
- Last updated
- 10 Jun 2015
- Results posted
- No
Publications
Kerr A, Clark A, Cooke EV, Rowe P, Pomeroy VM. Functional strength training and movement performance therapy produce analogous improvement in sit-to-stand early after stroke: early-phase randomised controlled trial. Physiotherapy. 2017 Sep;103(3):259-265. doi: 10.1016/j.physio.2015.12.006. Epub 2016 Feb 11.
PubMed 27107979
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke
- ClinicalTrials.gov ID
- NCT00322192
- Acronym / sponsor ID
- Health Foundation 224/1960
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, Physical Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- The Health Foundation
- Study start
- Jan 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 5 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy
Detailed description
Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.
An observer-blind randomised clinical trial. Subjects will be within 3 months of first stroke with some voluntary movement in the paretic lower limb. A power calculation estimated the sample size as 300. Research Physiotherapists, blinded to measurement, will recruit subjects, allocate subjects to one of the three intervention groups using sequentially numbered sealed envelopes containing previously randomised allocated intervention cards and provide interventions. The Research Assessors, blinded to intervention allocation will undertake all measurements. Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1) or functional strength training (experimental 2) will be provided for one hour, four times a week, for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting. Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are maximum torque around the knee joint, and gait velocity. The secondary outcomes include movement analysis, functional ability, corticospinal transmission (transcranial magnetic stimulation) and health related quality of life (Euroqol). The primary analysis will be analysis of covariance. A multiple comparison procedure (Gabriel's test) will be used to compare each pair of treatments. Euroqol data will be used to estimate the relative costs of the interventions and to calculate the incremental cost per QUALY gained. Every effort will be made to invite patients for assessment at outcome and follow-up even if they have withdrawn from therapy to allow the intention-to-treat principle to be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be aged over 50 years.
- be between one week and three months after stroke when recruited to the study;
- have been independently mobile indoors, with or without aids, before the stroke;
- have some voluntary movement in the paretic lower limb i.e. score above 28/100 on the lower limb section of the Motricity Index43;
- demonstrate adequate orientation and communication (be able to complete a one-stage command using the non-paretic upper limb e.g. point at the ceiling).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional UK Physical therapy | Behavioural | – |
| Increased intensity of UK conventional physical therapy | Behavioural | – |
| UK conventional physical therapy plus functional strength training | Behavioural | – |
Primary outcome
Maximum torque around the knee joint
gait velocity
7 secondary outcomes
Modified Rivermead Mobility Index
Lower limb kinematics during standing up
Lower limb kinematics during sitting down
Lower limb kinematics during walking
timing and pattern of muscle activation during functional activity
EuroQuol for health related quality of life
Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Derived from this study: PubMed 27107979Kerr A, Clark A, Cooke EV, Rowe P, Pomeroy VM. Functional strength training and movement performance therapy produce analogous improvement in sit-to-stand early after stroke: early-phase randomised controlled trial. Physiotherapy. 2017 Sep;103(3):259-265. doi: 10.1016/j.physio.2015.12.006. Epub 2016 Feb 11.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie M Pomeroy, PhD study chair
St George's University London, UK
Emma V Cooke, MSc principal investigator
St George's University London, UK
Raymond C Tallis, FMedSci study director
University of Manchester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional UK Physical therapy, Increased intensity of UK conventional physical therapy and UK conventional physical therapy plus functional strength training in people with Stroke, run by St George's, University of London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum torque around the knee joint. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00322192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.