Visual Cue Training to Improve Walking and Turning After Stroke: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Participant enrollment, recruitment and retention.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Participant enrollment, recruitment and retention.
时间窗: Ongoing for18 months after start of recruitment.
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.
次要结局
- SF-12(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)
- 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)
- Berg Balance Scale(Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months)
- 180 degree turn(Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months)
- Falls Efficacy Scale(Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months)
- Functional ambulation category(Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months)
- Gait speed(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)
研究者
Dr Kristen Hollands
Chief Investigator
University of Salford