Visual Cues for Gait Training Post-stroke
- Conditions
- Stroke
- Interventions
- Behavioral: Overground visual cue trainingBehavioral: Usual careBehavioral: Treadmill visual cue training
- Registration Number
- NCT01600391
- Lead Sponsor
- University of Salford
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Overground visual cue training Overground visual cue training 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. Usual Care Usual care A task specific-based intervention that does not include use of visual cues to influence quality or adaptability of gait. Treadmill visual cue training Treadmill visual cue training 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.
- Primary Outcome Measures
Name Time Method Participant enrollment, recruitment and retention. 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.
- Secondary Outcome Measures
Name Time Method SF-12 Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months 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
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 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
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 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.
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 Time taken (s) and number of steps (#) to complete a 180 degree turn
Falls Efficacy Scale Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months This will assess changes in confidence to walk without falling which may be expected as a result of practice of adaptable walking
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 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.
Gait adaptability Assessments take place at baseline, after completion of an 8 week training program and follow up at 3 months 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.
Trial Locations
- Locations (4)
Heart of England NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
South Warickshire NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Birmingham Community Health Care NHS Trust
🇬🇧Birmingham, West Midlands, United Kingdom
Sandwell and West Birmingham Hopsitals NHS Trust
🇬🇧Birmingham, United Kingdom