NCT01600391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

May 10, 2012

Last Update Submit

December 2, 2014

Conditions

Stroke

Keywords

StrokeVisual cuesGait rehabilitationWalking adaptabilityTurningOverground walkingTreadmill training

Outcome Measures

Primary Outcomes (1)

  • Participant enrollment, recruitment and retention.

    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.

    Ongoing for18 months after start of recruitment.

Secondary Outcomes (9)

  • 180 degree turn

    Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months

  • Gait adaptability

    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)

    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

    Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months

  • Berg Balance Scale

    Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months

  • +4 more secondary outcomes

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

A task specific-based intervention that does not include use of visual cues to influence quality or adaptability of gait.

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.

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.

Behavioral: Treadmill visual cue training

Interventions

Usual careBEHAVIORAL

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.

Also known as: Standard care, Standard physiotherapy
Usual Care
Overground visual cue trainingBEHAVIORAL

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.

Also known as: Visual cue gait training
Overground visual cue training
Treadmill visual cue trainingBEHAVIORAL

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.

Also known as: CMill, Forcelink, NL
Treadmill visual cue training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Birmingham Community Health Care NHS Trust

Birmingham, West Midlands, B13 8JL, United Kingdom

Location

Sandwell and West Birmingham Hopsitals NHS Trust

Birmingham, B18 7QH, United Kingdom

Location

Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

South Warickshire NHS Foundation Trust

Birmingham, CV2 2DX, United Kingdom

Location

Related Publications (10)

  • 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.

    PMID: 18425928BACKGROUND

  • 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.

    PMID: 21221956BACKGROUND

  • 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.

    PMID: 14966713BACKGROUND

  • Patla AE. Understanding the roles of vision in the control of human locomotion. Gait and Posture 5,(1):54-69,February 1997.

    BACKGROUND

  • 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.

    PMID: 3675173BACKGROUND

  • Griffin MP, Olney SJ et al. Role of symmetry in gait performance of stroke subjects with hemiplegia. Gait and Posture 3: 132-142, 1995

    BACKGROUND

  • Barela JA, Whitall J, et al. An examination of constraints affecting the intralimb coordination of hemiparetic gait. Human Movement Science 19: 251-273, 2000.

    BACKGROUND

  • 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.

    PMID: 11880898BACKGROUND

  • 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.

    PMID: 26445137DERIVED

  • 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.

    PMID: 24004882DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kristen Hollands, PhD

    University of Salford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 17, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

GB(4)