Stroke
Conditions
Brief summary
The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.
Interventions
DEVICELokomat
Robotic-assisted walking device
OTHERPhysical Therapy
Conventional physical therapy
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan * Age\>18 * At least 3 months post stroke at time of enrollment into study * Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently * Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4 * Ability to perform Lokomat ambulation training with assistance of 1 therapist * Ability to follow a three-step command * Physician approval for patient participation * Ability to give informed consent * Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies
Exclusion criteria
* Serious cardiac condition * Uncontrolled blood pressure, defined as \> 200 or diastolic \> 100 at rest * Hx of serious chronic obstructive pulmonary disease or oxygen dependence * Sever weight bearing pain * Lower extremity amputation * Claudication while walking * Life expectancy \< 1 year * History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months * Severe orthopedic problem * Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10-meter Walking Test (10mWT) | Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention |
Secondary
| Measure | Time frame |
|---|---|
| 6 Minute Walking Distance (6MWD) | Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lokomat Intervention | 11 |
| Standard of Care Conventional physical therapy | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care | Lokomat Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Age Continuous | 64.33 years STANDARD_DEVIATION 10.91 | 66.91 years STANDARD_DEVIATION 8.5 | 65.75 years STANDARD_DEVIATION 9.48 |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 11 | 3 / 9 |
| serious Total, serious adverse events | 2 / 11 | 2 / 9 |
Outcome results
Primary
10-meter Walking Test (10mWT)
Time frame: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
Population: Analysis was determined per protocol (i.e.between-group variation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Intervention 10-meter Walking Test (10mWT) Outcome | 10-meter Walking Test (10mWT) | Post-Intervention (mean=5.05 days post-therapy) | 0.20 meters per second (m/s) | Standard Deviation 0.1 |
| Lokomat Intervention 10-meter Walking Test (10mWT) Outcome | 10-meter Walking Test (10mWT) | Baseline | 0.20 meters per second (m/s) | Standard Deviation 0.1 |
| Lokomat Intervention 10-meter Walking Test (10mWT) Outcome | 10-meter Walking Test (10mWT) | Three-Month Follow-up | 0.21 meters per second (m/s) | Standard Deviation 0.1 |
| Standard of Care 10mWT Outcome | 10-meter Walking Test (10mWT) | Post-Intervention (mean=5.05 days post-therapy) | 0.27 meters per second (m/s) | Standard Deviation 0.27 |
| Standard of Care 10mWT Outcome | 10-meter Walking Test (10mWT) | Baseline | 0.18 meters per second (m/s) | Standard Deviation 0.12 |
| Standard of Care 10mWT Outcome | 10-meter Walking Test (10mWT) | Three-Month Follow-up | 0.28 meters per second (m/s) | Standard Deviation 0.29 |
| All Participants 10mWT Outcome | 10-meter Walking Test (10mWT) | Baseline | 0.19 meters per second (m/s) | Standard Deviation 0.11 |
| All Participants 10mWT Outcome | 10-meter Walking Test (10mWT) | Three-Month Follow-up | 0.24 meters per second (m/s) | Standard Deviation 0.2 |
| All Participants 10mWT Outcome | 10-meter Walking Test (10mWT) | Post-Intervention (mean=5.05 days post-therapy) | 0.23 meters per second (m/s) | Standard Deviation 0.19 |
Secondary
6 Minute Walking Distance (6MWD)
Time frame: Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Intervention 10-meter Walking Test (10mWT) Outcome | 6 Minute Walking Distance (6MWD) | Post-Intervention (mean=5.05 days post-therapy) | 57.02 meters (m) | Standard Deviation 25.5 |
| Lokomat Intervention 10-meter Walking Test (10mWT) Outcome | 6 Minute Walking Distance (6MWD) | Baseline | 53.94 meters (m) | Standard Deviation 30.53 |
| Lokomat Intervention 10-meter Walking Test (10mWT) Outcome | 6 Minute Walking Distance (6MWD) | Three-Month Follow-up | 57.82 meters (m) | Standard Deviation 25.99 |
| Standard of Care 10mWT Outcome | 6 Minute Walking Distance (6MWD) | Post-Intervention (mean=5.05 days post-therapy) | 70.26 meters (m) | Standard Deviation 60.4 |
| Standard of Care 10mWT Outcome | 6 Minute Walking Distance (6MWD) | Baseline | 48.77 meters (m) | Standard Deviation 21.04 |
| Standard of Care 10mWT Outcome | 6 Minute Walking Distance (6MWD) | Three-Month Follow-up | 76.89 meters (m) | Standard Deviation 62.29 |
| All Participants 10mWT Outcome | 6 Minute Walking Distance (6MWD) | Baseline | 51.61 meters (m) | Standard Deviation 26.16 |
| All Participants 10mWT Outcome | 6 Minute Walking Distance (6MWD) | Three-Month Follow-up | 66.40 meters (m) | Standard Deviation 45.65 |
| All Participants 10mWT Outcome | 6 Minute Walking Distance (6MWD) | Post-Intervention (mean=5.05 days post-therapy) | 62.98 meters (m) | Standard Deviation 43.86 |