Very Intensive Early Walking in Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | August 2015 |
Improving the Delivery of Intensive Gait Training in the Clinical Setting to Augment Community Ambulation
The purpose of this study is to demonstrate the efficacy of intensive locomotor
interventions early post stroke. An intensive locomotor training (LT) program will be
compared to an active control, conventional physical therapy. It is proposed that an early
and intensive stepping paradigm that is not typically employed early in physical therapy
will lead to superior outcomes and improved community mobility. A randomized, blinded,
controlled trial will test subjects with moderate to severe locomotor dysfunction in
individuals post-stroke to compare walking-related outcomes after intensive gait training
(including treadmill, overground, stair training, and skilled walking training) to outcomes
after conventional physical therapy.
interventions early post stroke. An intensive locomotor training (LT) program will be
compared to an active control, conventional physical therapy. It is proposed that an early
and intensive stepping paradigm that is not typically employed early in physical therapy
will lead to superior outcomes and improved community mobility. A randomized, blinded,
controlled trial will test subjects with moderate to severe locomotor dysfunction in
individuals post-stroke to compare walking-related outcomes after intensive gait training
(including treadmill, overground, stair training, and skilled walking training) to outcomes
after conventional physical therapy.
In Aim 2, intensive gait training overground and on the treadmill using the device as
appropriate will be provided using a randomized, controlled trial (RCT) design.
Determination of optimal swing phase and propulsive assistance provided to subjects to
maximize treadmill walking velocity (in Aim 1) will be necessary to assess the efficacy of
this technique to improve walking function over prolonged LT sessions. Consistent with work
from the previous grant cycle12, we will compare the relative improvements in impairments,
activity and participation following 1 of 2, 8 -week interventions to improve walking
ability post-stroke. Fifty-six (56) subjects will be recruited, stratified based on walking
10 meters [requiring moderate assistance (subject performing 50-74%), minimal assistance
(subject performing greater than 75% of gait but still needing assist), with a gait speed
<0.5m/s without assist, or with gait speed of >0.5-0.9m/s without assist. Subjects will be
randomized to experimental (intensive gait training using aforementioned gait training
principles) or control conditions (conventional physical therapy). The test group will
receive 40, 40-minute LT sessions during a 60 minute time period over 8 weeks with subjects
ambulating on the treadmill, overground, and on stairs. During the first 5 training
sessions, LT will take place solely on the treadmill. After that time, half of the sessions
will be walking overground and stairs and half on the treadmill. Training will be performed
with a target heart rate of 70-80% of heart rate reserve (HRR) and subjective ratings of
perceived exertion of 14-17 when patients are on medications to limit heart rate kinetics.
Kinematics during LT will be monitored visually to ensure proper foot placement necessary
for continuous stepping while maintaining the appropriate intensity, using the device as
necessary. The control group will receive conventional physical therapy (receiving at least
3 sessions of physical therapy per week) at the subject's and medical teams' discretion (day
rehabilitation, outpatient, or home health). If the subject is not receiving at least 3
sessions of physical therapy per week, control therapy treatments will be provided
consistent with recent data detailing the amount of specific physical therapy activities
provided during single-session outpatient visits19and published data21 as well as
unpublished data from Moore that delineates the number of steps taken per conventional
therapy session based on the gait speed of individual (number of steps during
training=1500*gait speed+200). The additional 200 steps were added to this algorithm to
allow for individuals who require assist to receive gait training during the sessions.
Clinical and quantitative assessment of neuromuscular and cardiopulmonary impairments,
limitations in activity and participation, assessment of corticospinal tract (CST)
excitability and integrity will be performed prior to training, mid-training, end of 8 week
training, and with a 2-6 month follow-up examination. Control group participants will have
the option of participating in 4 weeks of intensive gait training (experimental protocol) at
the end of the follow up testing and complete one more testing session at the end of those 4
weeks. Primary outcome measures include laboratory and community measures of ambulatory
function, including gait speed over short distances, distance walked and gait efficiency
during the 6 min walk, and the amount of daily community stepping (using Step Activity
Monitors [SAM]20), CST excitability measures using transcranial magnetic stimulation (TMS)
(optional) and assessment of white matter tract integrity using MRI (optional).
appropriate will be provided using a randomized, controlled trial (RCT) design.
Determination of optimal swing phase and propulsive assistance provided to subjects to
maximize treadmill walking velocity (in Aim 1) will be necessary to assess the efficacy of
this technique to improve walking function over prolonged LT sessions. Consistent with work
from the previous grant cycle12, we will compare the relative improvements in impairments,
activity and participation following 1 of 2, 8 -week interventions to improve walking
ability post-stroke. Fifty-six (56) subjects will be recruited, stratified based on walking
10 meters [requiring moderate assistance (subject performing 50-74%), minimal assistance
(subject performing greater than 75% of gait but still needing assist), with a gait speed
<0.5m/s without assist, or with gait speed of >0.5-0.9m/s without assist. Subjects will be
randomized to experimental (intensive gait training using aforementioned gait training
principles) or control conditions (conventional physical therapy). The test group will
receive 40, 40-minute LT sessions during a 60 minute time period over 8 weeks with subjects
ambulating on the treadmill, overground, and on stairs. During the first 5 training
sessions, LT will take place solely on the treadmill. After that time, half of the sessions
will be walking overground and stairs and half on the treadmill. Training will be performed
with a target heart rate of 70-80% of heart rate reserve (HRR) and subjective ratings of
perceived exertion of 14-17 when patients are on medications to limit heart rate kinetics.
Kinematics during LT will be monitored visually to ensure proper foot placement necessary
for continuous stepping while maintaining the appropriate intensity, using the device as
necessary. The control group will receive conventional physical therapy (receiving at least
3 sessions of physical therapy per week) at the subject's and medical teams' discretion (day
rehabilitation, outpatient, or home health). If the subject is not receiving at least 3
sessions of physical therapy per week, control therapy treatments will be provided
consistent with recent data detailing the amount of specific physical therapy activities
provided during single-session outpatient visits19and published data21 as well as
unpublished data from Moore that delineates the number of steps taken per conventional
therapy session based on the gait speed of individual (number of steps during
training=1500*gait speed+200). The additional 200 steps were added to this algorithm to
allow for individuals who require assist to receive gait training during the sessions.
Clinical and quantitative assessment of neuromuscular and cardiopulmonary impairments,
limitations in activity and participation, assessment of corticospinal tract (CST)
excitability and integrity will be performed prior to training, mid-training, end of 8 week
training, and with a 2-6 month follow-up examination. Control group participants will have
the option of participating in 4 weeks of intensive gait training (experimental protocol) at
the end of the follow up testing and complete one more testing session at the end of those 4
weeks. Primary outcome measures include laboratory and community measures of ambulatory
function, including gait speed over short distances, distance walked and gait efficiency
during the 6 min walk, and the amount of daily community stepping (using Step Activity
Monitors [SAM]20), CST excitability measures using transcranial magnetic stimulation (TMS)
(optional) and assessment of white matter tract integrity using MRI (optional).
Inclusion Criteria:
- subacute (<6 months) stroke
- 18-75 years old
- history of history of unilateral, supratentorial, ischemic or hemorrhage stroke
- able to walk 10m without physical assistance
- gait speed less than or equal to .8m/s
- medical clearance
Exclusion Criteria:
- significant cardiorespiratory or metabolic disease that may limit exercise
participation
- weight limit > 250 lbs (limit of most counter-weight safety systems)
- history of previous orthopedic or neurological conditions which may impair walking.
- women of childbearing potential will not be excluded, although women who are pregnant
will be excluded due to potential forces at trunk from the harness applied at the
waist.
- subjects with scores < 23 on the Mini Mental Status Exam
- Exclusion for transcranial magnetic stimulation (TMS):
- pacemaker
- metal implants in the head region
- history of epilepsy or seizures
- skull fractures or skull deficits
- concussion within the last 6 months
- unexplained recurring headaches
- medications that lower seizure threshold
- pregnancy
- Exclusion for the MRI:
- aneurysm clip or coil
- metal or wire implants
- heart valve prosthesis
We found this trial at
1
site
Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
Click here to add this to my saved trials
