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| ID | Type | Description | Link |
|---|---|---|---|
| Medallion Grant |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lokomat Intervention | Experimental | Lokomat gait training (five days a week for eight weeks for a total of 40 sessions). |
|
| Standard of Care | Active Comparator | Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Other | Conventional physical therapy |
| |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Noser, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lokomat Intervention | |
| FG001 | Standard of Care | Conventional physical therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lokomat Intervention | |
| BG001 | Standard of Care | Conventional physical therapy |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 10-meter Walking Test (10mWT) | Analysis was determined per protocol (i.e.between-group variation) | Posted | Mean | Standard Deviation | meters per second (m/s) | Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lokomat Intervention | Robotic-assisted gait therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin breakdown | Skin and subcutaneous tissue disorders | Skin breakdown as a result of therapy; adverse event deemed "definitely related" to protocol. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor skin breakdown | Skin and subcutaneous tissue disorders | minor skin breakdown |
Limitations include: small sample (n=21 enrolled, n=20 completed) and significant (p=0.025) difference between groups in time since stroke (Lokomat group, time since stroke mean=1353.60 days; Conventional group, time since stroke mean=525.00 days).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Noser | Mischer Neuroscience Institute, Memorial Hermann-TMC | elizabeth.noser@memorialhermann.org |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Lokomat |
| Device |
Robotic-assisted walking device |
|
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | All Participants 10mWT Outcome | Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor. |
|
|
| Secondary | 6 Minute Walking Distance (6MWD) | Posted | Mean | Standard Deviation | meters (m) | Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention |
|
|
|
| 2 |
| 11 |
| 5 |
| 11 |
| EG001 | Standard of Care | Conventional physical therapy | 2 | 9 | 3 | 9 |
|
| Hypotensive episode | Cardiac disorders | Sudden drop in blood pressure at subject's home leading to brief hospitalization; adverse event deemed "unrelated" to protocol. |
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| Chest pain | Cardiac disorders | Sudden chest pain prior to therapy leading to ER visit and brief hospitalization; adverse event deemed "unrelated" to protocol. |
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| Stroke | Vascular disorders | Subject with a second stroke during the post-treatment phase of study participation; adverse event deemed "unrelated" to protocol. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|
| Three-Month Follow-up |
|