Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-05-31
2014-03-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Usual Care
A task specific-based intervention that does not include use of visual cues to influence quality or adaptability of gait.
Usual care
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 training
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.
Overground visual cue 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 training
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.
Treadmill visual cue training
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.
Interventions
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Usual care
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 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 training
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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University of Birmingham
OTHER
University of Nottingham
OTHER
Stroke Research Network
UNKNOWN
University of Newcastle, Australia
OTHER
University of Salford
OTHER
Responsible Party
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Dr Kristen Hollands
Chief Investigator
Principal Investigators
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Kristen Hollands, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Salford
Locations
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Birmingham Community Health Care NHS Trust
Birmingham, West Midlands, United Kingdom
Sandwell and West Birmingham Hopsitals NHS Trust
Birmingham, , United Kingdom
Heart of England NHS Foundation Trust
Birmingham, , United Kingdom
South Warickshire NHS Foundation Trust
Birmingham, , United Kingdom
Countries
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References
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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.
Bank 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.
Bonan 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.
Patla 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.
Griffin 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.
Hollands 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.
Hollands 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.
Other Identifiers
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VCTpilot
Identifier Type: -
Identifier Source: org_study_id