Skip to content

Understanding Different Parameters in Locomotor Training (a Type of Walking Training) for Person After a Stroke

Developing Evidence-based Parameter Selection for Locomotor Training

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00712179
Enrollment
49
Registered
2008-07-09
Start date
2008-07-31
Completion date
2013-12-31
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, walking, Treadmill, body weight support system

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* adults at least 18 years old; * able to provide informed consent; * able to follow three-step motor command; * have a single unilateral stroke; * medically stable (i.e. asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with walking; * able to stand with assistance and/or ambulate 15 meters with or without an assistive device or brace and no greater than standby physical assistance.

Exclusion criteria

* weight \> 300 pounds due to limitations in body weight support systems; * body size which is incompatible with harnesses; * pregnancy; * presence of significant musculoskeletal problems that limit hip and knee extension or ankle plantarflexion to neutral; * self selected walking speed below 0.3 m/s; and * history of congestive cardiac failure, unstable angina, or peripheral vascular disease.

Design outcomes

Primary

MeasureTime frameDescription
DiagnosticDuring sessions- 1 day measurementThe electromyographic (EMG) gait pattern of stroke survivors was compared with normal pattern using z-scores.

Countries

United States

Participant flow

Participants by arm

ArmCount
Stroke Survivors
Cross-sectional study with a single group of stroke survivors
49
Total49

Baseline characteristics

CharacteristicStroke Survivors
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
18 Participants
Age, Categorical
Between 18 and 65 years
31 Participants
Age, Continuous61.1 years
STANDARD_DEVIATION 11.5
Baseline walking speed0.59 meters per second
STANDARD_DEVIATION 0.23
Region of Enrollment
United States
49 participants
Sex: Female, Male
Female
13 Participants
Sex: Female, Male
Male
36 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 37
serious
Total, serious adverse events
0 / 37

Outcome results

Primary

Diagnostic

The electromyographic (EMG) gait pattern of stroke survivors was compared with normal pattern using z-scores.

Time frame: During sessions- 1 day measurement

Population: Individuals with chronic stroke.

ArmMeasureGroupValue (MEAN)Dispersion
Stroke SurvivorsDiagnosticWalking at different speeds with 15% BWS1.57 Z-scoreStandard Error 0.058
Stroke SurvivorsDiagnosticWalking at self-selected speed at 0%, 15%, 30% BWS1.57 Z-scoreStandard Error 0.072
Stroke SurvivorsDiagnosticWalking at different speeds with 30% BWS1.55 Z-scoreStandard Error 0.075
Stroke SurvivorsDiagnosticFastest comfortable speed with different BWS1.56 Z-scoreStandard Error 0.073
Stroke SurvivorsDiagnosticModified non-paretic leg loading and movement1.64 Z-scoreStandard Error 0.079
Stroke SurvivorsDiagnosticModified paretic leg loading and movement1.38 Z-scoreStandard Error 0.061
Comparison: Null Hypothesis: Walking at different speeds with 15% body weight support will have no effect on EMG pattern.p-value: 0.981Mixed Models Analysis
Comparison: Null Hypothesis: Walking at self selected speed at 0%, 15% and 30% of body weight support will have no effect on EMG patternp-value: 0.84Mixed Models Analysis
Comparison: Null Hypothesis: Walking at different speeds with 30% body weight support will have no effect on EMG pattern.p-value: 0.16Mixed Models Analysis
Comparison: Null Hypothesis: Walking at fastest comfortable speeds with different amount of body weight supports will not affect the EMG pattern.p-value: 0.073Mixed Models Analysis
Comparison: Null Hypothesis: Modification of non-paretic leg loading and movement by the therapist will have no effect on EMG pattern of paretic leg.p-value: <0.001Mixed Models Analysis
Comparison: Null Hypothesis: Modification of paretic leg loading and movement by the therapist will have significant effect on EMG pattern of non-paretic leg.p-value: 0.94Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026