CVA (Cerebrovascular Accident)
Conditions
Keywords
Stroke, Rehabilitation, Walking, Biomechanics
Brief summary
This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.
Detailed description
This study seeks to develop a theory-based clinical decision-making framework for the training of walking recovery after stroke based on how different biomechanical patterns of walking illustrate distinct motor control deficits. Each participant will complete 12 sessions (three times a week for four weeks) of either INCLINE, DECLINE, or CONTROL training. Clinical and biomechanical outcome measures will be collected pre- and post-training and after a one-month follow-up period. In addition, the investigators will collect a battery of clinical outcome measures before and after training. Spatiotemporal variables (including SSWS) will be collected before and after each session. All clinical and biomechanical assessments will be conducted by an evaluator blinded to training group allocation.
Interventions
OTHERIncline treadmill walking
Those with a Pp \<0.47 or \>0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
OTHERDecline treadmill walking
Those with a Pp \<0.47 or \>0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
OTHERLevel Treadmill (Control)
Those with a Pp \<0.47 or \>0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* stroke 6 months * residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) * ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing) * Ability to walk on a treadmill without orthotic or assistive device using overhead harness system * provision of informed consent, and 8) written approval from the primary physician (see attached sample of Medical Approval Cover Letter).
Exclusion criteria
* history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADLs * History of COPD or oxygen dependence * Pre-existing neurological disorders or dementia * History of major head trauma * Pp between 0.47 and 0.53 * Legal blindness or severe visual impairment * Severe arthritis or other problems that limit passive ROM * History of DVT or pulmonary embolism within 6 months * Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Speed | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. | Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Paretic Propulsion Symmetry | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. | Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Personalized Training Effect on SSWS and Pp - Incline Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Incline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. | 19 |
| Personalized Training Effect on SSWS and Pp - Decline Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Decline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. | 19 |
| Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Level treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. | 17 |
| Total | 55 |
Baseline characteristics
| Characteristic | Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) | Total | Personalized Training Effect on SSWS and Pp - Incline | Personalized Training Effect on SSWS and Pp - Decline |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 22 Participants | 7 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 33 Participants | 12 Participants | 12 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 10.34 | 60.96 years STANDARD_DEVIATION 9.02 | 61.32 years STANDARD_DEVIATION 8.33 | 60.79 years STANDARD_DEVIATION 9.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 54 Participants | 18 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 00 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 23 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 32 Participants | 9 Participants | 12 Participants |
| Region of Enrollment United States | 17 Participants | 55 Participants | 19 Participants | 19 Participants |
| Sex: Female, Male Female | 4 Participants | 17 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 13 Participants | 38 Participants | 14 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 17 |
Outcome results
Primary
Change in Gait Speed
Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed.
Time frame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Training Effect on SSWS and Pp - Incline | Change in Gait Speed | 0.15 meters/second | Standard Deviation 0.004 |
| Personalized Training Effect on SSWS and Pp - Decline | Change in Gait Speed | 0.075 meters/second | Standard Deviation 0.053 |
| Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) | Change in Gait Speed | 0.127 meters/second | Standard Deviation 0.062 |
Secondary
Change in Paretic Propulsion Symmetry
Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg.
Time frame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Training Effect on SSWS and Pp - Incline | Change in Paretic Propulsion Symmetry | -0.023 Percentage of Propulsion | Standard Deviation 0.042 |
| Personalized Training Effect on SSWS and Pp - Decline | Change in Paretic Propulsion Symmetry | -0.034 Percentage of Propulsion | Standard Deviation 0.02 |
| Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) | Change in Paretic Propulsion Symmetry | 0.043 Percentage of Propulsion | Standard Deviation 0.013 |