StrokeVCTpilotNCT01600391
Visual Cues for Gait Training Post-stroke
A study testing Overground visual cue training and Treadmill visual cue training in people with Stroke, run by University of Salford at 4 sites in United Kingdom.
Trial summary
Given that visual information comprises one of the most important and salient sources of information used during walking, that visual cues have been shown to be more effective than auditory cues in triggering gait adjustments and that stroke survivors have been reported to become more dependent on visual cues, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Overground visual cue training and Treadmill visual cue training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- May 2012to Mar 2014
- Phase
- Interventional
- 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
- Diagnosis of stroke
- Able to walk 10 metres with or without assistance
- Residual paresis in the lower limb (Fugl-Meyer Lower Limb score less than 34)
- Informed written consent.
Who cannot join
- Gait speed more than 0.8 m/s
- Patients with a premorbid (retrospective) modified Rankin Scale score of greater than 3
- Gait deficits attributable to non-stroke pathology
- Visual impairments preventing use of visual cue training (as assessed by Apple Cancellation test
- Concurrent progressive neurologic disorder, acute coronary syndrome, severe heart failure, confirmed or suspected lower-limb fracture preventing mobilization, and those requiring palliative care
- Inability to follow a three step command (as assessed by Modified mini-mental status exam).
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Birmingham Community Health Care NHS Trust
Birmingham, West Midlands, B13 8JL
Sandwell and West Birmingham Hopsitals NHS Trust
Birmingham, B18 7QH
Heart of England NHS Foundation Trust
Birmingham, B9 5SS
South Warickshire NHS Foundation Trust
Birmingham, CV2 2DX
About this study
Official title: Visual Cue Training to Improve Walking and Turning After Stroke: a Pilot Study
Given that visual information comprises one of the most important and salient sources of information used during walking, that visual cues have been shown to be more effective than auditory cues in triggering gait adjustments and that stroke survivors have been reported to become more dependent on visual cues, the investigators hypothesize that visual cues would be more effective in triggering gait recovery and adaptability following stroke than interventions not including visual cues.
The investigators will integrate visual cues with walking and turning practice, and contrast this intervention to routine overground walking practice. Stroke participants recruited from NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three gait rehabilitation groups. Each group will receive the same frequency and duration of treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and usual care (UC) groups will be treated in participating NHS sites. Treadmill training with visual cues (TVCT) will take place at the University of Birmingham.
Read the detailed description
The gait of many stroke patients remains impoverished and characterized by impairments including asymmetries in propulsive forces between the paretic and non-paretic limbs, step lengths, widths and stance and swing phase durations. Currently there is insufficient evidence that current rehabilitation strategies improve walking in people who are more than 6 months post-stroke.
The purpose of the trial is to determine the necessary information on which to base a future definitive trial examining the effectiveness of visual cues for gait training following stroke in contrast to conventional over-ground walking practice.
The study will determine the numbers of patients willing to be recruited into both control and VCT groups; the willingness of physiotherapists at each collaborating site to enroll patients to usual care OVCT and TVCT groups.
It will determine the numbers of patients who do not complete the allocated treatment, thus dropping out of the study, and the reasons for dropping out.
The knowledge gathered about recruitment, outcomes and drop-out rates will determine sample size for a subsequent definitive trial.
The study will also measure completeness of outcome data, i.e. percentage of patients with no missing values in outcome assessments.
- Conditions
- Stroke
- Being tested
- Usual care, Overground visual cue training, Treadmill visual cue training
- Keywords
- Stroke, Visual cues, Gait rehabilitation, Walking adaptability, Turning, Overground walking, Treadmill training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Also called Standard care, Standard physiotherapy
Walking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Usual care intervention that does not include use of visual cues to influence quality or adaptability of gait.
Overground visual cue trainingBehavioural
Also called Visual cue gait training
Walking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Overground visual cue training will involve stepping to targets, which are positioned to improve walking pattern according to needs identified in baseline assessment. Treatment will progress from practice of improved stepping pattern (symmetry of stepping) and speed to practice of adjusting footfalls by avoiding targets randomly, as one might need to be able to do to avoid an obstacle or an uneven surface. Training will also involve turning practice.Overground visual cue training will be delivered by National Health Service therapists in participating National Health Service sites.
Treadmill visual cue trainingBehavioural
Also called CMill, Forcelink, NL
Walking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Treadmill training with visual cues will be delivered using a force-instrumented treadmill (CMill, Forcelink, NL). The Treadmill visual cue training will involve participants stepping to targets shone onto a treadmill. Treatment will progress from practice of improved stepping pattern (symmetry of stepping) and speed to practice of adjusting footfalls by avoiding targets randomly, as one might need to be able to do to avoid an obstacle or an uneven surface. Training will also involve turning practice. Treadmill visual cue training will be delivered by qualified physiotherapists at the University of Birmingham.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | A task specific-based intervention that does not include use of visual cues to influence quality or adaptability of gait. Receives: Behavioral: Usual care |
| Overground visual cue training | Experimental | Overground visual cue training will involve stepping to targets which are positioned to improve gait symmetry and speed. Training will include turning practice and the avoidance of obstacles for adaptability during straight walking. Receives: Behavioral: Overground visual cue training |
| Treadmill visual cue training | Experimental | Treadmill training with visual cues will be delivered using a force-instrumented treadmill (CMill, Forcelink, NL). Walking training will involve stepping to targets which are positioned to improve gait symmetry and speed. Training will include turning practice and the avoidance of obstacles for adaptability during straight walking. Receives: Behavioral: Treadmill visual cue training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant enrollment, recruitment and retention.
Determine:
- The numbers of patients willing to be recruited into both control and VCT groups.
- The willingness of physiotherapists at each collaborating site to enrol patients to both control and VCT groups.
- The numbers of patients who do not complete the allocated treatment, thus dropping out of the study, and determine the reasons for dropping out.
- Measure completeness of outcome data, i.e. percentage of patients with no missing values in outcome assessments.
Measured: Ongoing for18 months after start of recruitment.
Secondary outcomes (9)
180 degree turn
Time taken (s) and number of steps (#) to complete a 180 degree turn
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Gait adaptability
The number of times participants fail to hit stepping targets when these are presented unpredictably in timing and location will be used to indicate the ability to adapt the straight gait pattern according to environmental demands.
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Timed up and Go (TUG) test (7m)
The subject begins by sitting up strait in a chair with their hands on their thighs and their backs touching the back of the chair. After they are given the go signal, they rise from the chair, walk at their normal speed, turn around right after passing the tape at the end of the pathway, return back to the chair, turn around and sit down.
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Fugl-Meyer Lower Limb Motor Assessment
Items are rated on a three point scale (0= cannot perform, 1 = performs partially, 2 = performs fully) and standardised protocols for administration will be followed
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Berg Balance Scale
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Falls Efficacy Scale
This will assess changes in confidence to walk without falling which may be expected as a result of practice of adaptable walking
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
SF-12
This is a short-form health survey with only 12 questions. It yields an 8-scale profile of functional health and well-being scores, including physical functioning, and social, emotional, mental and general health and has been included to measure effects on broader quality of life
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Functional ambulation category
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Gait speed
Proportion of participants achieving a gait speed of 0.4 m/s and 0.8 m/s. Gait speed will be measured during a 10 metre walk.
Measured: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University of Nottingham, Stroke Research Network, University of Newcastle, Australia
- Responsible party
- Principal investigator, Dr Kristen Hollands, University of Salford
- Investigators
- Kristen Hollands, PhD, Principal investigator, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600391
- Sponsor's protocol ID
- VCTpilot
- Acronym
- VCTpilot
- Status last verified
- Dec 2014
- First submitted
- 10 May 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aziz NA, Leonardi-Bee J, Phillips M, Gladman JR, Legg L, Walker MF. Therapy-based rehabilitation services for patients living at home more than one year after stroke. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD005952. doi: 10.1002/14651858.CD005952.pub2.
PubMed 18425928Bank PJ, Roerdink M, Peper CE. Comparing the efficacy of metronome beeps and stepping stones to adjust gait: steps to follow! Exp Brain Res. 2011 Mar;209(2):159-69. doi: 10.1007/s00221-010-2531-9. Epub 2011 Jan 8.
PubMed 21221956Bonan IV, Yelnik AP, Colle FM, Michaud C, Normand E, Panigot B, Roth P, Guichard JP, Vicaut E. Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Feb;85(2):274-8. doi: 10.1016/j.apmr.2003.06.016.
PubMed 14966713Patla AE. Understanding the roles of vision in the control of human locomotion. Gait and Posture 5,(1):54-69,February 1997.
Lehmann JF, Condon SM, Price R, deLateur BJ. Gait abnormalities in hemiplegia: their correction by ankle-foot orthoses. Arch Phys Med Rehabil. 1987 Nov;68(11):763-71.
PubMed 3675173Griffin MP, Olney SJ et al. Role of symmetry in gait performance of stroke subjects with hemiplegia. Gait and Posture 3: 132-142, 1995
Barela JA, Whitall J, et al. An examination of constraints affecting the intralimb coordination of hemiparetic gait. Human Movement Science 19: 251-273, 2000.
Hollands MA, Patla AE, Vickers JN. "Look where you're going!": gaze behaviour associated with maintaining and changing the direction of locomotion. Exp Brain Res. 2002 Mar;143(2):221-30. doi: 10.1007/s00221-001-0983-7. Epub 2002 Jan 10.
PubMed 11880898Hollands KL, Pelton TA, Wimperis A, Whitham D, Tan W, Jowett S, Sackley CM, Wing AM, Tyson SF, Mathias J, Hensman M, van Vliet PM. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial. PLoS One. 2015 Oct 7;10(10):e0139261. doi: 10.1371/journal.pone.0139261. eCollection 2015.
PubMed 26445137Hollands KL, Pelton T, Wimperis A, Whitham D, Jowett S, Sackley C, Alan W, van Vliet P. Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial. Trials. 2013 Sep 3;14:276. doi: 10.1186/1745-6215-14-276.
PubMed 24004882
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Cue Training to Improve Walking and Turning After Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT01600391
- Acronym / sponsor ID
- VCTpilot / VCTpilot
- Conditions
- Stroke
- Keywords
- Stroke, Visual cues, Gait rehabilitation, Walking adaptability, Turning, Overground walking, Treadmill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- University of Birmingham, University of Nottingham, Stroke Research Network, University of Newcastle, Australia
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 May 2012 (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.
Given that visual information comprises one of the most important and salient sources of information used during walking, that visual cues have been shown to be more effective than auditory cues in triggering gait adjustments and that stroke survivors have been reported to become more dependent on visual cues, the investigators hypothesize that visual cues would be more effective in triggering gait recovery and adaptability following stroke than interventions not including visual cues.
The investigators will integrate visual cues with walking and turning practice, and contrast this intervention to routine overground walking practice. Stroke participants recruited from NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three gait rehabilitation groups. Each group will receive the same frequency and duration of treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and usual care (UC) groups will be treated in participating NHS sites. Treadmill training with visual cues (TVCT) will take place at the University of Birmingham.
Detailed description
The gait of many stroke patients remains impoverished and characterized by impairments including asymmetries in propulsive forces between the paretic and non-paretic limbs, step lengths, widths and stance and swing phase durations. Currently there is insufficient evidence that current rehabilitation strategies improve walking in people who are more than 6 months post-stroke.
The purpose of the trial is to determine the necessary information on which to base a future definitive trial examining the effectiveness of visual cues for gait training following stroke in contrast to conventional over-ground walking practice.
The study will determine the numbers of patients willing to be recruited into both control and VCT groups; the willingness of physiotherapists at each collaborating site to enroll patients to usual care OVCT and TVCT groups.
It will determine the numbers of patients who do not complete the allocated treatment, thus dropping out of the study, and the reasons for dropping out.
The knowledge gathered about recruitment, outcomes and drop-out rates will determine sample size for a subsequent definitive trial.
The study will also measure completeness of outcome data, i.e. percentage of patients with no missing values in outcome assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careA task specific-based intervention that does not include use of visual cues to influence quality or adaptability of gait. |
| Overground visual cue training | Experimental | Behavioral: Overground visual cue trainingOverground visual cue training will involve stepping to targets which are positioned to improve gait symmetry and speed. Training will include turning practice and the avoidance of obstacles for adaptability during straight walking. |
| Treadmill visual cue training | Experimental | Behavioral: Treadmill visual cue trainingTreadmill training with visual cues will be delivered using a force-instrumented treadmill (CMill, Forcelink, NL). Walking training will involve stepping to targets which are positioned to improve gait symmetry and speed. Training will include turning practice and the avoidance of obstacles for adaptability during straight walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of stroke
- Able to walk 10 metres with or without assistance
- Residual paresis in the lower limb (Fugl-Meyer Lower Limb score less than 34)
- Informed written consent.
Key exclusion criteria (6 listed)
- Gait speed more than 0.8 m/s
- Patients with a premorbid (retrospective) modified Rankin Scale score of greater than 3
- Gait deficits attributable to non-stroke pathology
- Visual impairments preventing use of visual cue training (as assessed by Apple Cancellation test
- Concurrent progressive neurologic disorder, acute coronary syndrome, severe heart failure, confirmed or suspected lower-limb fracture preventing mobilization, and those requiring palliative care
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 |
|---|---|---|
| Usual careAlso: Standard care, Standard physiotherapyWalking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Usual care intervention that does not include use of visual cues to influence quality or adaptability of gait. | Behavioural | Usual Care |
| Overground visual cue trainingAlso: Visual cue gait trainingWalking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Overground visual cue training will involve stepping to targets, which are positioned to improve walking pattern according to needs identified in baseline assessment. Treatment will progress from practice of improved stepping pattern (symmetry of stepping) and speed to practice of adjusting footfalls by avoiding targets randomly, as one might need to be able to do to avoid an obstacle or an uneven surface. Training will also involve turning practice.Overground visual cue training will be delivered by National Health Service therapists in participating National Health Service sites. | Behavioural | Overground visual cue training |
| Treadmill visual cue trainingAlso: CMill, Forcelink, NLWalking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Treadmill training with visual cues will be delivered using a force-instrumented treadmill (CMill, Forcelink, NL). The Treadmill visual cue training will involve participants stepping to targets shone onto a treadmill. Treatment will progress from practice of improved stepping pattern (symmetry of stepping) and speed to practice of adjusting footfalls by avoiding targets randomly, as one might need to be able to do to avoid an obstacle or an uneven surface. Training will also involve turning practice. Treadmill visual cue training will be delivered by qualified physiotherapists at the University of Birmingham. | Behavioural | Treadmill visual cue training |
Primary outcome
Participant enrollment, recruitment and retention.
Time frame: Ongoing for18 months after start of recruitment.
Determine: 1. The numbers of patients willing to be recruited into both control and VCT groups. 2. The willingness of physiotherapists at each collaborating site to enrol patients to both control and VCT groups. 3. The numbers of patients who do not complete the allocated treatment, thus dropping out of the study, and determine the reasons for dropping out. 4. Measure completeness of outcome data, i.e. percentage of patients with no missing values in outcome assessments.
9 secondary outcomes
180 degree turn
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Gait adaptability
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Timed up and Go (TUG) test (7m)
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Fugl-Meyer Lower Limb Motor Assessment
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Berg Balance Scale
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Falls Efficacy Scale
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
SF-12
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Functional ambulation category
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Gait speed
Time frame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
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 3 Dec 2014.
- Background: PubMed 18425928Aziz NA, Leonardi-Bee J, Phillips M, Gladman JR, Legg L, Walker MF. Therapy-based rehabilitation services for patients living at home more than one year after stroke. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD005952. doi: 10.1002/14651858.CD005952.pub2.
- Background: PubMed 21221956Bank PJ, Roerdink M, Peper CE. Comparing the efficacy of metronome beeps and stepping stones to adjust gait: steps to follow! Exp Brain Res. 2011 Mar;209(2):159-69. doi: 10.1007/s00221-010-2531-9. Epub 2011 Jan 8.
- Background: PubMed 14966713Bonan IV, Yelnik AP, Colle FM, Michaud C, Normand E, Panigot B, Roth P, Guichard JP, Vicaut E. Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Feb;85(2):274-8. doi: 10.1016/j.apmr.2003.06.016.
- BackgroundPatla AE. Understanding the roles of vision in the control of human locomotion. Gait and Posture 5,(1):54-69,February 1997.
- Background: PubMed 3675173Lehmann JF, Condon SM, Price R, deLateur BJ. Gait abnormalities in hemiplegia: their correction by ankle-foot orthoses. Arch Phys Med Rehabil. 1987 Nov;68(11):763-71.
- BackgroundGriffin MP, Olney SJ et al. Role of symmetry in gait performance of stroke subjects with hemiplegia. Gait and Posture 3: 132-142, 1995
- BackgroundBarela JA, Whitall J, et al. An examination of constraints affecting the intralimb coordination of hemiparetic gait. Human Movement Science 19: 251-273, 2000.
- Background: PubMed 11880898Hollands MA, Patla AE, Vickers JN. "Look where you're going!": gaze behaviour associated with maintaining and changing the direction of locomotion. Exp Brain Res. 2002 Mar;143(2):221-30. doi: 10.1007/s00221-001-0983-7. Epub 2002 Jan 10.
- Derived from this study: PubMed 26445137Hollands KL, Pelton TA, Wimperis A, Whitham D, Tan W, Jowett S, Sackley CM, Wing AM, Tyson SF, Mathias J, Hensman M, van Vliet PM. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial. PLoS One. 2015 Oct 7;10(10):e0139261. doi: 10.1371/journal.pone.0139261. eCollection 2015.
- Derived from this study: PubMed 24004882Hollands KL, Pelton T, Wimperis A, Whitham D, Jowett S, Sackley C, Alan W, van Vliet P. Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial. Trials. 2013 Sep 3;14:276. doi: 10.1186/1745-6215-14-276.
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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.
Kristen Hollands, PhD principal investigator
University of Salford
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overground visual cue training and Treadmill visual cue training in people with Stroke, run by University of Salford 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 4 inclusion and 6 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 3 Dec 2014. 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.
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?
Participant enrollment, recruitment and retention. (time frame: Ongoing for18 months after start of recruitment.). 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 NCT01600391, which also lists 10 linked publications.
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 3 Dec 2014.