An observational study in Stroke, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by VA Office of Research and Development · Observational
This is a research study to understand how people who have experienced a stroke walk in order to develop better and more effective types of therapy. Data collected from people who have experienced a stroke and healthy individuals will be used to compare a neurologically healthy person to someone, which has sustained an injury.
The first day will be a chance for the participants to become familiar with the body weight support (BWS) system and walking at different speeds. This first day will last about 2 hours and will consistent of fifteen total minutes of locomotor training utilizing manual trainers. This means trainers will move the participants'' body into a more normal walking pattern. The participants will be given a chance to rest between bouts; however, the participants may also rest at any point.
First, the participants will walk for five minutes at normal comfortable speed with 15% of the body weight supported through an overhead system. This will be followed by walking at speeds faster and slower than the participants' comfortable speed. After these initial bouts of stepping, will be the training bouts. Training will be conducted with 30% of the body weight supported and at speeds considered normal for adults. Trainers will assist the trunk and with each leg, and will assist with initiation of steps and leg positioning, maintenance of an upright trunk, pelvic rotation, and weight shift. Training will consist of three bouts of five minutes of stepping for a total duration of 15 minutes of stepping. Vital signs, heart rate and blood pressure, will be monitored after each 5-minute bout. If the participants wear an Ankle Foot Orthosis (AFO), the participants will be asked to walk without it, but the investigators will provide the participants with an Aircast, which supports the ankle and prevents it from rolling side to side, but allows the foot to move freely up and down ,
Data will be collected on the second day. This will take approximately five hours. During this time the participants will be asked to walk on the ground and on a treadmill. For the overground portion, the participants will walk across a 14-foot level, pressure-sensitive walkway at the participants' own speed and then as fast as the participants' can safely. This walkway measures the speed of walking and the size of steps. The participants can use any assistive device that the participants' typically use. A physical therapist or trained assistant will walk beside as the participants walk across the walkway. The participants will be asked to walk several times across the walkway at the two speeds while recordings are made from the participants' muscles and are videotaped.
The participants will also be asked to walk on a treadmill. The participants will be permitted to practice treadmill walking until the participants' feel comfortable. Once the participants feel comfortable the investigators will ask the participants to walk a couple different ways. The order will be random, and the speeds will be determined from the first visit. The participants will be asked to walk some with Body Weight Support and some without. The investigators will ask the participants to walk at the participants' comfortable speed and then as fast as the participants' can safely walk. The participants will also walk at these same speeds and percentage of body weight support while trainers help the participants step in a way as close to normal.
The participants will be able to rest at any point and for as long as they wish, however, after each trial the participants will be required to rest at least 2 minutes.
During all treadmill walking, the participants will wear a harness attached to a mobile device attached to the ceiling. This device is for safety to prevent a fall and it can catch the participants should they lose balance or stumble. It will also be used to provide body weight support for some of the walking trials. If the participants use braces and/or assistive devices, the participants will be asked to do some walking with and without them, according to the participants' comfort and safety. A therapist will walk with the participants to provide any physical assistance that may be needed.
For the walking testing, the investigators may need to shave small areas of the participants' legs to attach small sensors to the skin to measure the electrical activity of the leg muscles. The investigators will also attach reflective markers or small angle measurement devices to the skin over the participants' hips and several locations on the legs. The investigators will film the participants' movements with video cameras.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 49 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy Controls and persons who have sustained a stroke
Exclusion Criteria:
Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions.
Diagnostic
The electromyographic (EMG) gait pattern of stroke survivors was compared with "normal" pattern using z-scores.
Time frame: During sessions- 1 day measurement
| Milestone | Stroke Survivors |
|---|---|
| Started | 49 |
| Completed | 37 |
| Not completed | 12 |
The electromyographic (EMG) gait pattern of stroke survivors was compared with "normal" pattern using z-scores.
| Z-score | Stroke Survivors |
|---|---|
| Walking at different speeds with 15% BWS | 1.57 ± 0.058 |
| Walking at self-selected speed at 0%, 15%, 30% BWS | 1.57 ± 0.072 |
| Walking at different speeds with 30% BWS | 1.55 ± 0.075 |
| Fastest comfortable speed with different BWS | 1.56 ± 0.073 |
| Modified non-paretic leg loading and movement | 1.64 ± 0.079 |
| Modified paretic leg loading and movement | 1.38 ± 0.061 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stroke Survivors | — | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | Stroke Survivors |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 31 |
| >=65 years | 18 |
| Age, Continuous(years) | Stroke Survivors |
|---|---|
| Mean | 61.1 ± 11.5 |
| Sex: Female, Male(Participants) | Stroke Survivors |
|---|---|
| Female | 13 |
| Male | 36 |
| Region of Enrollment(participants) | Stroke Survivors |
|---|---|
| United States | 49 |
| Baseline walking speed(meters per second) | Stroke Survivors |
|---|---|
| Mean | 0.59 ± 0.23 |
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