Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery.
This is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-Intensity Locomotor Training Program | Experimental | Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. |
|
| High-Intensity Locomotor Training Program | Experimental | Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. |
|
| High-Step Count Locomotor Training Program | Active Comparator | Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-Intensity Locomotor Training Program | Behavioral | The moderate-intensity program prescribes participants to exert 50-59% of their heart rate (HR) reserve, or a score of 13-15 on Borg's rating of perceived exertion (RPE) scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale (BBS) Score | The BBS is a 14-item objective assessment that static balance and fall risk in adults. Each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from ranges from 0 to 56, with lower scores indicating a higher risk of falling and lower functional mobility. | Discharge Assessment (Day 13-14) |
| Ten Meter Walk Test (10mWT) Time | The 10mWT is an assessment of walking speed in meters per second over a distance of 10 meters. | Discharge Assessment (Day 13-14) |
| Six Minute Walk Test (6MWT) Distance | The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants walk around the perimeter of a set circuit for a total of six minutes. The measure is the total distance covered in six minutes. | Discharge Assessment (Day 13-14) |
| Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers | The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (transfer) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient. | Discharge Assessment (Day 13-14) |
| IRF-PAI - Admission QI Score: Cumulative Ambulation | The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (ambulation) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Discharged at Home | Discharge Assessment (Day 13-14) | |
| Number of Patients Discharged at Subacute Rehabilitation Facility | Discharge Assessment (Day 13-14) | |
Not provided
Inclusion Criteria:
• Primary diagnosis of stroke
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Camillieri | Contact | 212-598-6044 | Susan.camillieri@nyulangone.org | |
| Melissa Chung | Contact | 646-654-3519 | Melissa.chung@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Susan Camillieri | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: susan.camillieri@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to susan.camillieri@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| High-Intensity Locomotor Training Program | Behavioral | The high-intensity program prescribes participants to exert at least 60% of their heart rate (HR) reserve, or a score of 16-18 on the RPE scale. |
|
| High-Step Count Locomotor Training Program | Behavioral | The high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE. |
|
| Discharge Assessment (Day 13-14) |
| IRF-PAI - Admission QI Score: Cumulative Stairs | The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (stairs) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient. | Discharge Assessment (Day 13-14) |
| Number of Steps of Locomotor Training |
Measurement of adherence to protocols. |
| Discharge Assessment (Day 13-14) |
| Time Spent in Locomotor Training | Measurement of adherence to protocols. | Discharge Assessment (Day 13-14) |
| Number of Minutes Spent in Target HR Zone | Measurement of adherence to protocols. | Discharge Assessment (Day 13-14) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided