CVA (Cerebrovascular Accident)NCT03602313
Biomechanical Gait Analysis in Patients Post-Stroke
A study testing Body Weight Support Gait Training and Traditional Gait Training in people with CVA (Cerebrovascular Accident) and Stroke, run by Florida Gulf Coast University.
Trial summary
Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA (Cerebrovascular Accident), Stroke
- What is being tested?
- Body Weight Support Gait Training and Traditional Gait Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2011to 17 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current in-patient in acute care for Cerebrovascular accident (CVA),
- Unilateral CVA affecting at least the lower limb, and
- Medically stable as determined by the rehabilitation physician.
Who cannot join
- Previous (more than 1) CVA with residual lower limb deficit, and
- Any lower extremity pathology on the affected side other than the effects of the CVA.
About this study
Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.
Read the detailed description
Potential participants are identified upon admission to acute care post cerebrovascular accident (CVA) and screened for inclusion. Informed consent is obtained from the patient and/or designee. Demographic information is obtained from the medical record, the patient and/or designee by the clinical coordinator. The participant is randomized into traditional gait training group or body weight support (BWS) group. The participant receives the required amount of physical therapy as directed by clinicians at the acute care facility and accrediting agencies.
The traditional gait training group will receive gait training as presently performed without additional modalities. The BWS group will received BWS gait training in lieu of traditional gait training. Participants will be treated in in-patient rehabilitation for a duration as determined by the clinical team; thus, the overall duration of care may be variable between participants. Time spent in gait training activities for both groups will be tracked by both service unit and by time (minutes).
Within 48 hours of discharge from the acute care facility, the participant will be transported to a separate site for kinematic gait analysis using a marker based motion capture system.
The procedure for gait analysis is as follows:
- Investigators will place reflective markers on the following areas using non-latex adhesive tape: top of the shoulders, bony part of the pelvis on the front and back, hips, front of the thighs, outside of the knees, front of the shins, outside of the ankles, first and fifth toes, and back of each heel.
- The participant will walk across the room in the gait analysis lab no more than 20 times at his/her choice of pace while the camera system records gait parameters and kinematics. He/she will be allowed to rest as needed during the data collection.
- The reflective markers and adhesive tape will be removed and the participant thanked for his/her participation.
- Conditions
- CVA (Cerebrovascular Accident), Stroke
- Being tested
- Body Weight Support Gait Training, Traditional Gait Training
- Keywords
- Body Weight Support
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Weight Support Gait TrainingDevice
Also called BSWTT, LiteGait
Traditional Gait TrainingOther
Also called Overground
| Study group | Role | What they receive |
|---|---|---|
| Traditional Gait Training | Active comparator | The Traditional Gait Training group will receive gait training as presently performed without additional modalities. Receives: Other: Traditional Gait Training |
| Body Weight Support Training | Experimental | The Body Weight Support group will received body weight support gait training in lieu of traditional gait training. Receives: Device: Body Weight Support Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Velocity of center of mass of the participant.
Measured: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Step Length
Difference in position between the feet at heel strike, in the direction of forward motion.
Measured: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Step Width
Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.
Measured: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Step Asymmetry
The ratio of the difference of left and right step length over the stride length.
Measured: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Secondary outcomes (3)
Gait Units
Measure of the quantity of therapy received during the duration of care.
Measured: Measured at discharge, approximately 21 days
Functional Independence Measure (FIM)
A 17 items survey of patient independence in 2 domains, motor and cognition. It is used as a basic indicator of patient disability.
Measured: Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days
Length of Stay
Total duration of care at the acute rehabilitation facility.
Measured: Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start6 Dec 2011
- Primary completion17 Sep 2015
- Study completion17 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to 1 of 2 groups for the duration of the study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek J Lura, PhD, Principal investigator, Florida Gulf Coast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602313
- Sponsor's protocol ID
- 2011-40
- Status last verified
- Jul 2018
- First submitted
- 4 May 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Gait Analysis in Patients Post-Stroke
- ClinicalTrials.gov ID
- NCT03602313
- Acronym / sponsor ID
- 2011-40
- Conditions
- CVA (Cerebrovascular Accident), Stroke
- Keywords
- Body Weight Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 6 Dec 2011 (actual)
- Primary completion
- 17 Sep 2015 (actual)
- Study completion
- 17 Sep 2015 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.
Detailed description
Potential participants are identified upon admission to acute care post cerebrovascular accident (CVA) and screened for inclusion. Informed consent is obtained from the patient and/or designee. Demographic information is obtained from the medical record, the patient and/or designee by the clinical coordinator. The participant is randomized into traditional gait training group or body weight support (BWS) group. The participant receives the required amount of physical therapy as directed by clinicians at the acute care facility and accrediting agencies.
The traditional gait training group will receive gait training as presently performed without additional modalities. The BWS group will received BWS gait training in lieu of traditional gait training. Participants will be treated in in-patient rehabilitation for a duration as determined by the clinical team; thus, the overall duration of care may be variable between participants. Time spent in gait training activities for both groups will be tracked by both service unit and by time (minutes).
Within 48 hours of discharge from the acute care facility, the participant will be transported to a separate site for kinematic gait analysis using a marker based motion capture system.
The procedure for gait analysis is as follows:
- Investigators will place reflective markers on the following areas using non-latex adhesive tape: top of the shoulders, bony part of the pelvis on the front and back, hips, front of the thighs, outside of the knees, front of the shins, outside of the ankles, first and fifth toes, and back of each heel.
- The participant will walk across the room in the gait analysis lab no more than 20 times at his/her choice of pace while the camera system records gait parameters and kinematics. He/she will be allowed to rest as needed during the data collection.
- The reflective markers and adhesive tape will be removed and the participant thanked for his/her participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to 1 of 2 groups for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Traditional Gait Training | Active comparator | Other: Traditional Gait TrainingThe Traditional Gait Training group will receive gait training as presently performed without additional modalities. |
| Body Weight Support Training | Experimental | Device: Body Weight Support Gait TrainingThe Body Weight Support group will received body weight support gait training in lieu of traditional gait training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current in-patient in acute care for Cerebrovascular accident (CVA),
- Unilateral CVA affecting at least the lower limb, and
- Medically stable as determined by the rehabilitation physician.
Key exclusion criteria (2 listed)
- Previous (more than 1) CVA with residual lower limb deficit, and
- Any lower extremity pathology on the affected side other than the effects of the CVA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Weight Support Gait TrainingAlso: BSWTT, LiteGait | Device | Body Weight Support Training |
| Traditional Gait TrainingAlso: Overground | Other | Traditional Gait Training |
Primary outcome
Gait Speed
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Velocity of center of mass of the participant.
Step Length
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Difference in position between the feet at heel strike, in the direction of forward motion.
Step Width
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.
Step Asymmetry
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
The ratio of the difference of left and right step length over the stride length.
3 secondary outcomes
Gait Units
Time frame: Measured at discharge, approximately 21 days
Functional Independence Measure (FIM)
Time frame: Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days
Length of Stay
Time frame: Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Related trials for CVA (Cerebrovascular Accident)
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek J Lura, PhD principal investigator
Florida Gulf Coast University
Questions about this trial
What is this clinical trial studying?
A study testing Body Weight Support Gait Training and Traditional Gait Training in people with CVA (Cerebrovascular Accident) and Stroke, run by Florida Gulf Coast University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.