7 years, what the hell happened to this? Where is the protocol located? Bad news; they cherry picked participants.
Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial
Hollands et al. Trials 2013, 14:276
http://www.trialsjournal.com/content/14/1/276
Kristen L Hollands 1*,
Trudy Pelton 2,
Andrew Wimperis 3,
Diane Whitham 4,
Sue Jowett 2,
Catherine Sackley 5,
Wing Alan 2
Paulette van Vliet 6
Paulette van Vliet 6
Abstract
Background:
Visual information comprises one of the most salient sources of information used to control walkingand the dependence on vision to maintain dynamic stability increases following a stroke. We hypothesize,therefore, that rehabilitation efforts incorporating visual cues may be effective in triggering recovery andadaptability of gait following stroke
.
This feasibility trial aims to estimate probable recruitment rate, effect size,treatment adherence and response to gait training with visual cues in contrast to conventional overground walkingpractice following stroke.
Methods/design:
A 3-arm, parallel group, multicentre, single blind, randomised control feasibility trial will compareoverground visual cue training (O-VCT), treadmill visual cue training (T-VCT), and usual care (UC). Participants(n = 60) will be randomly assigned to one of three treatments by a central randomisation centre using computer generated tables to allocate treatment groups. The research assessor will remain blind to allocation. Treatment,delivered by physiotherapists, will be twice weekly for 8 weeks at participating outpatient hospital sites for the O-VCT or UC and in a University setting for T-VCT participants.Individuals with gait impairment due to stroke, with restricted community ambulation (gait speed <0.8m/s), residual lower limb paresis and who are able to take part in repetitive walking practice involving visual cues (i.e., no severe visual impairments, able to walk with minimal assistance and no comorbid medical contraindications for walking practice) will be included. The primary outcomes concerning participant enrolment, recruitment, retention, and health and social careresource use data will be recorded over a recruitment period of 18 months. Secondary outcome measures will be undertaken before randomisation (baseline), after the eight-week intervention (outcome), and at three months(follow-up). Outcome measures will include gait speed and step length symmetry; time and steps taken to complete a 180° turn; assessment of gait adaptability (success rate in target stepping); timed up and go; Fugl-Meyer lower limb motor assessment; Berg balance scale; falls efficacy scale; SF-12; and functional ambulation category.
Discussion:
Participation and compliance measured by treatment logs, accrual rate, attrition, and response variation will determine sample sizes for an early phase randomised controlled trial and indicate whether a definitive late phase efficacy trial is justified.
Trial registration:
Clinicaltrials.gov, NCT01600391.
Keywords:
Gait, Rehabilitation, Stroke, Vision
* Correspondence: k.hollands@salford.ac.uk
Visual information comprises one of the most salient sources of information used to control walkingand the dependence on vision to maintain dynamic stability increases following a stroke. We hypothesize,therefore, that rehabilitation efforts incorporating visual cues may be effective in triggering recovery andadaptability of gait following stroke
.
This feasibility trial aims to estimate probable recruitment rate, effect size,treatment adherence and response to gait training with visual cues in contrast to conventional overground walkingpractice following stroke.
Methods/design:
A 3-arm, parallel group, multicentre, single blind, randomised control feasibility trial will compareoverground visual cue training (O-VCT), treadmill visual cue training (T-VCT), and usual care (UC). Participants(n = 60) will be randomly assigned to one of three treatments by a central randomisation centre using computer generated tables to allocate treatment groups. The research assessor will remain blind to allocation. Treatment,delivered by physiotherapists, will be twice weekly for 8 weeks at participating outpatient hospital sites for the O-VCT or UC and in a University setting for T-VCT participants.Individuals with gait impairment due to stroke, with restricted community ambulation (gait speed <0.8m/s), residual lower limb paresis and who are able to take part in repetitive walking practice involving visual cues (i.e., no severe visual impairments, able to walk with minimal assistance and no comorbid medical contraindications for walking practice) will be included. The primary outcomes concerning participant enrolment, recruitment, retention, and health and social careresource use data will be recorded over a recruitment period of 18 months. Secondary outcome measures will be undertaken before randomisation (baseline), after the eight-week intervention (outcome), and at three months(follow-up). Outcome measures will include gait speed and step length symmetry; time and steps taken to complete a 180° turn; assessment of gait adaptability (success rate in target stepping); timed up and go; Fugl-Meyer lower limb motor assessment; Berg balance scale; falls efficacy scale; SF-12; and functional ambulation category.
Discussion:
Participation and compliance measured by treatment logs, accrual rate, attrition, and response variation will determine sample sizes for an early phase randomised controlled trial and indicate whether a definitive late phase efficacy trial is justified.
Trial registration:
Clinicaltrials.gov, NCT01600391.
Keywords:
Gait, Rehabilitation, Stroke, Vision
* Correspondence: k.hollands@salford.ac.uk
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