Visual Cues for Gait Training Post-stroke "VCTpilot"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Usual care Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual Care
    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 Behavioral
    Other Names: Visual cue gait training
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Overground visual cue training
    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.
  • Treadmill visual cue training Behavioral
    Other Names: CMill, Forcelink, NL
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Treadmill visual cue training
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Participant enrollment, recruitment and retention. Ongoing for18 months after start of recruitment. No
Secondary 180 degree turn Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months No
Secondary Gait adaptability Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months No
Secondary 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 No
Secondary 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 No
Secondary Berg Balance Scale Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months No
Secondary Falls Efficacy Scale Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months No
Secondary SF-12 Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months No
Secondary Functional ambulation category Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months No
Secondary Gait speed Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months No

Sponsors