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Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial.

ABSTRACT: Visual information comprises one of the most salient sources of information used to control walking and 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 and adaptability 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 walking practice following stroke.A 3-arm, parallel group, multi-centre, single blind, randomised control feasibility trial will compare overground 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 care resource 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.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.Clinicaltrials.gov, NCT01600391.

SUBMITTER: Hollands KL

PROVIDER: S-EPMC3846668 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial.

Hollands Kristen L KL Pelton Trudy T Wimperis Andrew A Whitham Diane D Jowett Sue S Sackley Catherine C Alan Wing W van Vliet Paulette P

Trials 20130903

<h4>Background</h4>Visual information comprises one of the most salient sources of information used to control walking and 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 and adaptability of gait following stroke. This feasibility trial aims to estimate probable recruitment rate, effect size, treatment adherence and response to gait trainin ...[more]

PMID: 24004882

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Project description:BackgroundElectromechanical and robotic-assisted gait training devices are used in rehabilitation and might help to improve walking after stroke. This is an update of a Cochrane Review first published in 2007.ObjectivesTo investigate the effects of automated electromechanical and robotic-assisted gait training devices for improving walking after stroke.Search methodsWe searched the Cochrane Stroke Group Trials Register (last searched April 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 2), MEDLINE (1966 to November 2012), EMBASE (1980 to November 2012), CINAHL (1982 to November 2012), AMED (1985 to November 2012), SPORTDiscus (1949 to September 2012), the Physiotherapy Evidence Database (PEDro, searched November 2012) and the engineering databases COMPENDEX (1972 to November 2012) and INSPEC (1969 to November 2012). We handsearched relevant conference proceedings, searched trials and research registers, checked reference lists and contacted authors in an effort to identify further published, unpublished and ongoing trials.Selection criteriaWe included all randomised and randomised cross-over trials consisting of people over 18 years old diagnosed with stroke of any severity, at any stage, or in any setting, evaluating electromechanical and robotic-assisted gait training versus normal care.Data collection and analysisTwo review authors independently selected trials for inclusion, assessed methodological quality and extracted the data. The primary outcome was the proportion of participants walking independently at follow-up.Main resultsIn this update of our review, we included 23 trials involving 999 participants. Electromechanical-assisted gait training in combination with physiotherapy increased the odds of participants becoming independent in walking (odds ratio (OR) (random effects) 2.39, 95% confidence interval (CI) 1.67 to 3.43; P < 0.00001; I² = 0%) but did not significantly increase walking velocity (mean difference (MD) = 0.04 metres/s, 95% CI -0.03 to 0.11; P = 0.26; I² = 73%) or walking capacity (MD = 3 metres walked in six minutes, 95% CI -29 to 35; P = 0.86; I² = 70%). The results must be interpreted with caution because (1) some trials investigated people who were independent in walking at the start of the study, (2) we found variations between the trials with respect to devices used and duration and frequency of treatment, and (3) some trials included devices with functional electrical stimulation. Our planned subgroup analysis suggests that people in the acute phase may benefit but people in the chronic phase may not benefit from electromechanical-assisted gait training. Post hoc analysis showed that people who are non-ambulatory at intervention onset may benefit but ambulatory people may not benefit from this type of training. Post hoc analysis showed no differences between the types of devices used in studies regarding ability to walk, but significant differences were found between devices in terms of walking velocity.Authors' conclusionsPeople who receive electromechanical-assisted gait training in combination with physiotherapy after stroke are more likely to achieve independent walking than people who receive gait training without these devices. Specifically, people in the first three months after stroke and those who are not able to walk seem to benefit most from this type of intervention. The role of the type of device is still not clear. Further research should consist of a large definitive, pragmatic, phase III trial undertaken to address specific questions such as the following: What frequency or duration of electromechanical-assisted gait training might be most effective? How long does the benefit last?

Project description:Annually, some 9000 people in Switzerland suffer a first time stroke. Of these 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise activity of the hemiplegic side increase ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" (a corset with elasticated strapping) significantly increases hemiplegic muscle activity during gait. The aim of the present study is to investigate the long term effects on the recovery of gait, balance and social participation of gait rehabilitation with TheraTogs compared to gait rehabilitation with a cane following first time acute stroke.Multi-centre, single blind, randomised trial with 120 patients after first stroke. When subjects have reached Functional Ambulation Category 3 they will be randomly allocated into TheraTogs or cane group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardised procedure. Cane walking held at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with only the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented. The intervention will continue for five weeks or until patients have reached Functional Ambulation category 5. Outcome measures will be assessed the day before begin of intervention, the day after completion, 3 months, 6 months and 2 years.Timed "up and go" test, secondary outcomes: peak surface EMG of gluteus maximus and gluteus medius, activation patterns of hemiplegic leg musculature, temporo-spatial gait parameters, hemiplegic hip kinematics in the frontal and sagittal planes, dynamic balance, daily activity measured by accelerometry, Stroke Impact Scale. Significance levels will be 5% with 95% CI's. IntentionToTreat analyses will be performed. Descriptive statistics will be presented.This study could have significant implications for the clinical practice of gait rehabilitation after stroke, particularly the effect and appropriate use of walking aids.The results could be important for the development of clinical guidelines and for the socio-economic costs of post-stroke care.ClinicalTrials.gov NCT01366729.

Project description:Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. After stroke, individuals demonstrate a diminished ability to perform dual-tasks. Current evidence suggests that conventional rehabilitation does not adequately address gait-related dual-task impairments after stroke, which may be contributing to low levels of participation and physical inactivity in community-dwelling stroke survivors. The objective of this study is to investigate the efficacy of dual-task gait training in community-dwelling adults within 1 year of stroke. Specifically, we will compare the effects of dual-task gait training and single-task gait training on cognitive-motor interference during walking at preferred speed and at fastest comfortable speed (Aim 1), locomotor control during obstacle negotiation (Aim 2), and spontaneous physical activity (Aim 3).This single-blind randomized controlled trial will involve 44 individuals within 12 months of stroke. Following baseline evaluation, participants will be randomly allocated to single- or dual-task gait training. Both groups will receive 12, 30-minute sessions provided one-on-one over 4-6 weeks in an outpatient therapy setting. Single-task gait training involves practice of gait activities incorporating motor relearning principles. Dual-task gait training involves an identical gait training protocol; the critical difference being that the dual-task gait training group will practice the gait activities while simultaneously performing a cognitive task for 75% of the repetitions. Blinded assessors will measure outcomes at baseline, post-intervention, and 6 months after completion of the intervention. The primary outcome measure will be dual-task effects on gait speed and cognition during unobstructed walking. Secondary outcomes include spatiotemporal and kinetic gait parameters during unobstructed single- and dual-task walking at preferred and fastest comfortable walking speeds, gait parameters during high and low obstacle crossing, spontaneous physical activity, executive function, lower extremity motor function, Timed Up and Go, balance self-efficacy, number of falls, and stroke-related disability. Hypotheses for each aim will be tested using an intention-to-treat analysis with repeated measures ANOVA design.This trial will provide evidence to help clinicians make decisions about the types of activities to include in rehabilitation to improve dual-task walking after stroke.ClinicalTrials.gov NCT01568957.

Dataset Information

Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial.

Publications

Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial.

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