Clinical trial NCT01600391: Visual Cues for Gait Training Post-stroke
Official title: Visual Cue Training to Improve Walking and Turning After Stroke: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Visual cues
Gait rehabilitation
Walking adaptability
Turning
Overground walking
Treadmill training
Lead sponsor: University of Salford
Sponsor class: OTHER
Collaborators: name: University of Birmingham
name: University of Nottingham
name: Stroke Research Network
name: University of Newcastle, Australia
First posted: 2012-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Participant enrollment, recruitment and retention.
timeFrame: Ongoing for18 months after start of recruitment.
Secondary outcomes:
measure: 180 degree turn
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: Gait adaptability
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: Timed up and Go (TUG) test (7m)
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: Fugl-Meyer Lower Limb Motor Assessment
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: Berg Balance Scale
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: Falls Efficacy Scale
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: SF-12
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: Functional ambulation category
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
measure: Gait speed
timeFrame: Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Community Health Care NHS Trust
state: West Midlands
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham Hopsitals NHS Trust
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: South Warickshire NHS Foundation Trust
Study officials:
affiliation: University of Salford
name: Kristen Hollands, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Patla AE. Understanding the roles of vision in the control of human locomotion. Gait and Posture 5,(1):54-69,February 1997.
citation: 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.
citation: Griffin MP, Olney SJ et al. Role of symmetry in gait performance of stroke subjects with hemiplegia. Gait and Posture 3: 132-142, 1995
citation: Barela JA, Whitall J, et al. An examination of constraints affecting the intralimb coordination of hemiparetic gait. Human Movement Science 19: 251-273, 2000.
citation: 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.
citation: 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.
citation: 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.