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Visual Cues for Gait Training Post-stroke (VCTpilot)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Usual care
Overground visual cue training
Treadmill visual cue training
Sponsored by
University of Salford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Visual cues, Gait rehabilitation, Walking adaptability, Turning, Overground walking, Treadmill training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Birmingham Community Health Care NHS Trust
  • Sandwell and West Birmingham Hopsitals NHS Trust
  • Heart of England NHS Foundation Trust
  • South Warickshire NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual Care

Overground visual cue training

Treadmill visual cue training

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

180 degree turn
Time taken (s) and number of steps (#) to complete a 180 degree turn
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.
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.
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
Berg Balance Scale
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
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
Functional ambulation category
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.

Full Information

First Posted
May 10, 2012
Last Updated
December 2, 2014
Sponsor
University of Salford
Collaborators
University of Birmingham, University of Nottingham, Stroke Research Network, University of Newcastle, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01600391
Brief Title
Visual Cues for Gait Training Post-stroke
Acronym
VCTpilot
Official Title
Visual Cue Training to Improve Walking and Turning After Stroke: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salford
Collaborators
University of Birmingham, University of Nottingham, Stroke Research Network, University of Newcastle, Australia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Visual cues, Gait rehabilitation, Walking adaptability, Turning, Overground walking, Treadmill training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
A task specific-based intervention that does not include use of visual cues to influence quality or adaptability of gait.
Arm Title
Overground visual cue training
Arm Type
Experimental
Arm Description
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.
Arm Title
Treadmill visual cue training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Other Intervention Name(s)
Standard care, Standard physiotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Overground visual cue training
Other Intervention Name(s)
Visual cue gait training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treadmill visual cue training
Other Intervention Name(s)
CMill, Forcelink, NL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant enrollment, recruitment and retention.
Description
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.
Time Frame
Ongoing for18 months after start of recruitment.
Secondary Outcome Measure Information:
Title
180 degree turn
Description
Time taken (s) and number of steps (#) to complete a 180 degree turn
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
Gait adaptability
Description
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.
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
Timed up and Go (TUG) test (7m)
Description
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.
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
Fugl-Meyer Lower Limb Motor Assessment
Description
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
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
Berg Balance Scale
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
Falls Efficacy Scale
Description
This will assess changes in confidence to walk without falling which may be expected as a result of practice of adaptable walking
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
SF-12
Description
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
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
Functional ambulation category
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months
Title
Gait speed
Description
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.
Time Frame
Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Hollands, PhD
Organizational Affiliation
University of Salford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Community Health Care NHS Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B13 8JL
Country
United Kingdom
Facility Name
Sandwell and West Birmingham Hopsitals NHS Trust
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Heart of England NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
South Warickshire NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
CV2 2DX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18425928
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.
Results Reference
background
PubMed Identifier
21221956
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.
Results Reference
background
PubMed Identifier
14966713
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.
Results Reference
background
Citation
Patla AE. Understanding the roles of vision in the control of human locomotion. Gait and Posture 5,(1):54-69,February 1997.
Results Reference
background
PubMed Identifier
3675173
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.
Results Reference
background
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
Results Reference
background
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.
Results Reference
background
PubMed Identifier
11880898
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.
Results Reference
background
PubMed Identifier
26445137
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.
Results Reference
derived
PubMed Identifier
24004882
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.
Results Reference
derived

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Visual Cues for Gait Training Post-stroke

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