Treadmill Training at Constant or Different Speeds for People With Traumatic Brain Injury
| Status: | Terminated |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | July 29, 2011 |
| End Date: | January 6, 2014 |
Effect of Time Varying Walking Velocity in Body-Weight Supported Treadmill Training
Background:
- Many people who have had a traumatic brain injury have difficulty walking. Training on a
treadmill is often used to help people with walking difficulties. Supporting a person s body
weight with a harness while using the treadmill can help improve walking skills in people
with brain injury. Varying the rate at which people walk on the treadmill may also help more
than walking at a constant rate. Treadmill training with body weight support or walking at
different speeds may improve walking skills in people who have had a traumatic brain injury.
More research is needed to see if one method is better than the other.
Objectives:
- To compare the effects of two types of treadmill training in people who have had a
traumatic brain injury.
Eligibility:
- People at least 18 years of age who have had a mild or moderate traumatic brain injury at
least 6 months ago and have mild or moderate walking difficulty.
Design:
- Participants will be screened with a medical history and physical exam. They will also
take a basic walking test (not on a treadmill).
- Participants will be divided into two groups. The first group will have treadmill
training at a constant speed. The second group will have treadmill training at different
speeds. All participants will wear a support harness while walking on the treadmill.
- At the first training visit, participants will have a gait assessment with different
tests of walking. Then they will have a treadmill walking session.
- After the first visit, participants will return twice a week for 6 weeks for treadmill
training sessions (visits 3 through 12). They will also have grip strength and walking
tests.
- At the end of 6 weeks, participants will have a final treadmill training session, and
will have a gait assessment exactly like the one in the first training visit.
- At 6 months after the final session, participants will have a followup visit with a
final gait assessment.
- Many people who have had a traumatic brain injury have difficulty walking. Training on a
treadmill is often used to help people with walking difficulties. Supporting a person s body
weight with a harness while using the treadmill can help improve walking skills in people
with brain injury. Varying the rate at which people walk on the treadmill may also help more
than walking at a constant rate. Treadmill training with body weight support or walking at
different speeds may improve walking skills in people who have had a traumatic brain injury.
More research is needed to see if one method is better than the other.
Objectives:
- To compare the effects of two types of treadmill training in people who have had a
traumatic brain injury.
Eligibility:
- People at least 18 years of age who have had a mild or moderate traumatic brain injury at
least 6 months ago and have mild or moderate walking difficulty.
Design:
- Participants will be screened with a medical history and physical exam. They will also
take a basic walking test (not on a treadmill).
- Participants will be divided into two groups. The first group will have treadmill
training at a constant speed. The second group will have treadmill training at different
speeds. All participants will wear a support harness while walking on the treadmill.
- At the first training visit, participants will have a gait assessment with different
tests of walking. Then they will have a treadmill walking session.
- After the first visit, participants will return twice a week for 6 weeks for treadmill
training sessions (visits 3 through 12). They will also have grip strength and walking
tests.
- At the end of 6 weeks, participants will have a final treadmill training session, and
will have a gait assessment exactly like the one in the first training visit.
- At 6 months after the final session, participants will have a followup visit with a
final gait assessment.
Objectives: To test the effectiveness of using time varying walking velocity in Body-Weight
Supported Treadmill Training (BWSTT) as compared to using constant velocity in subjects with
Traumatic Brain Injury (TBI). We hypothesize that using time varying velocity will result in
a greater improvement in ambulatory function.
Study Population: 30 adult subjects with a clinical diagnosis of non-penetrating TBI and with
functional deficits in gait will be enrolled. Subjects will be recruited from NIH, affiliated
hospitals/clinics, and in the community.
Design: This pilot study will use an instrumented treadmill (Bertec Co., Columbus, Ohio) and
a force controlled harness system called ZeroG (Aretech LLC, Ashburn, Virginia). Subjects
will be randomly assigned to one of two groups (12 subjects per group): the first group will
receive BWSTT at a constant velocity (also known as standard treadmill training); and the
second group will receive BWSTT at randomized time varying velocity. BWSTT at time varying
velocity consists of two components: 1) subjects passively adjusting their walking speed to
the continuously changing speed of the treadmill; and 2) subjects actively changing their
walking speed by following the instructed walking speed displayed on a monitor screen while
the treadmill is automatically adjusted to the subjects speed. Each group will receive 8 gait
training sessions (30 minutes per session, twice per week) for four weeks. Gait performance
will be tested before (pre-test) and after (post-test) the 8 session gait training program.
Outcome Measures: The primary outcome measures are parameters representing gait performance:
maximum walking speed, self-selected walking speed, cadence, stride length, percentage of
swing, stance and double stance periods, gait symmetry, Time Up and Go (TUG), and Dynamic
Gait Index (DGI) scores. The secondary outcome measure is physical and cognitive effort
exerted during the training session as evaluated by grip-strength test and LNS (Letter-Number
Sequencing) test.
Supported Treadmill Training (BWSTT) as compared to using constant velocity in subjects with
Traumatic Brain Injury (TBI). We hypothesize that using time varying velocity will result in
a greater improvement in ambulatory function.
Study Population: 30 adult subjects with a clinical diagnosis of non-penetrating TBI and with
functional deficits in gait will be enrolled. Subjects will be recruited from NIH, affiliated
hospitals/clinics, and in the community.
Design: This pilot study will use an instrumented treadmill (Bertec Co., Columbus, Ohio) and
a force controlled harness system called ZeroG (Aretech LLC, Ashburn, Virginia). Subjects
will be randomly assigned to one of two groups (12 subjects per group): the first group will
receive BWSTT at a constant velocity (also known as standard treadmill training); and the
second group will receive BWSTT at randomized time varying velocity. BWSTT at time varying
velocity consists of two components: 1) subjects passively adjusting their walking speed to
the continuously changing speed of the treadmill; and 2) subjects actively changing their
walking speed by following the instructed walking speed displayed on a monitor screen while
the treadmill is automatically adjusted to the subjects speed. Each group will receive 8 gait
training sessions (30 minutes per session, twice per week) for four weeks. Gait performance
will be tested before (pre-test) and after (post-test) the 8 session gait training program.
Outcome Measures: The primary outcome measures are parameters representing gait performance:
maximum walking speed, self-selected walking speed, cadence, stride length, percentage of
swing, stance and double stance periods, gait symmetry, Time Up and Go (TUG), and Dynamic
Gait Index (DGI) scores. The secondary outcome measure is physical and cognitive effort
exerted during the training session as evaluated by grip-strength test and LNS (Letter-Number
Sequencing) test.
- INCLUSION CRITERIA:
Subjects eligible for participation in this research study must meet the following
inclusion criteria:
Diagnosis of non-penetrating TBI, specifically functionally mild to moderate TBI (those
individuals who demonstrate the ability or capacity to ambulate)
Injury occurred at least 6 months prior to enrollment
Age of 18 or older
Able to stand and walk on a treadmill for 30 minutes (with some breaks in the middle)
Have mild or moderate functional gait impairment (score 1 or 2 in the first two tests in
DGI: 1. Gait Level Surface test and 2. Change in Gait Speed test)
Able to provide informed consent
Able to read 3 inch by 3 inch letters in the monitor located at 1 meter distance from the
treadmill without affecting gait patterns on the treadmill.
EXCLUSION CRITERIA:
Subjects are not eligible for participation in this research study if any of the following
conditions exist:
Taking medications that affect motor function such as baclofen, levodopa, benzodiazepams,
tizanadine, or dantrolene sodium.
Had surgery to either lower limb within the last year or requires surgery during the period
of the study
Had botulinum toxin injections in lower limbs within the last 4 months or willing to forego
botulinum toxins in lower limbs for the duration of the study
Are currently receiving any type of gait training or similar intervention outside of the
study or unwilling to forego initiation of such an intervention during the period of this
study
Presence of severe pain in the lower limbs (VAS 5 or above)
Medical or psychological instability such that the clinician judges that the subject is
unsafe to enroll in the study or the subject cannot answer questions or follow instructions
to fulfill the study
Any known cardiac or pulmonary disease
A woman with pregnancy
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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