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Incline Training to Personalize Motor Control Interventions After Stroke

Primary Purpose

CVA (Cerebrovascular Accident)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incline treadmill walking
Decline treadmill walking
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CVA (Cerebrovascular Accident) focused on measuring Stroke, Rehabilitation, Walking, Biomechanics

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • stroke 6 months
  • residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
  • ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing)
  • Pp between 0.47 and 0.53
  • Ability to walk on a treadmill without orthotic or assistive device using overhead harness system
  • provision of informed consent, and 8) written approval from the primary physician (see attached sample of Medical Approval Cover Letter).

Exclusion Criteria:

  • history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADLs
  • History of COPD or oxygen dependence
  • Pre-existing neurological disorders or dementia
  • History of major head trauma
  • Legal blindness or severe visual impairment
  • Severe arthritis or other problems that limit passive ROM
  • History of DVT or pulmonary embolism within 6 months
  • Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest.

Sites / Locations

  • Ralph H. Johnson VA Medical Center, Charleston, SC
  • MUSC Center for Rehabilitation Research in Neurologic Conditions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Personalized training effect on SSWS

Personalized training effect on Pp

Positive response

Arm Description

Determine the efficacy of motor control deficit guided personalized training on SSWS compared to non-personalized and CONTROL interventions. Incline treadmill walking Decline treadmill walking

Determine the efficacy of motor control deficit guided personalized training on increasing symmetry of Pp compared to non-personalized and CONTROL interventions. Incline treadmill walking Decline treadmill walking

Determine if the personalized intervention increase the positive response rate compared to non-personalized and CONTROL interventions, and to further advance personalize interventions by identifying factors that predict response. Incline treadmill walking Decline treadmill walking

Outcomes

Primary Outcome Measures

Change in Gait Speed
10 Meter Walk Test

Secondary Outcome Measures

Change in Paretic Propulsion Symmetry
Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg.

Full Information

First Posted
May 23, 2018
Last Updated
July 28, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03561246
Brief Title
Incline Training to Personalize Motor Control Interventions After Stroke
Official Title
Incline Training to Personalize Motor Control Interventions After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.
Detailed Description
This study seeks to develop a theory-based clinical decision-making framework for the training of walking recovery after stroke based on how different biomechanical patterns of walking illustrate distinct motor control deficits. Each participant will complete 12 sessions (three times a week for four weeks) of either INCLINE, DECLINE, or CONTROL training. Clinical and biomechanical outcome measures will be collected pre- and post-training and after a one-month follow-up period. In addition, the investigators will collect a battery of clinical outcome measures before and after training. Spatiotemporal variables (including SSWS) will be collected before and after each session. All clinical and biomechanical assessments will be conducted by an evaluator blinded to training group allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVA (Cerebrovascular Accident)
Keywords
Stroke, Rehabilitation, Walking, Biomechanics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized training effect on SSWS
Arm Type
Active Comparator
Arm Description
Determine the efficacy of motor control deficit guided personalized training on SSWS compared to non-personalized and CONTROL interventions. Incline treadmill walking Decline treadmill walking
Arm Title
Personalized training effect on Pp
Arm Type
Active Comparator
Arm Description
Determine the efficacy of motor control deficit guided personalized training on increasing symmetry of Pp compared to non-personalized and CONTROL interventions. Incline treadmill walking Decline treadmill walking
Arm Title
Positive response
Arm Type
Active Comparator
Arm Description
Determine if the personalized intervention increase the positive response rate compared to non-personalized and CONTROL interventions, and to further advance personalize interventions by identifying factors that predict response. Incline treadmill walking Decline treadmill walking
Intervention Type
Other
Intervention Name(s)
Incline treadmill walking
Intervention Description
Those with a Pp 0.47 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
Intervention Type
Other
Intervention Name(s)
Decline treadmill walking
Intervention Description
Those with a Pp 0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
Primary Outcome Measure Information:
Title
Change in Gait Speed
Description
10 Meter Walk Test
Time Frame
Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart, and follow-up at 1 month after the last training session.
Secondary Outcome Measure Information:
Title
Change in Paretic Propulsion Symmetry
Description
Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg.
Time Frame
Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart, and follow-up at 1 month after the last training session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: stroke 6 months residual paresis in the lower extremity (Fugl-Meyer LE motor score <34) ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing) Pp between 0.47 and 0.53 Ability to walk on a treadmill without orthotic or assistive device using overhead harness system provision of informed consent, and 8) written approval from the primary physician (see attached sample of Medical Approval Cover Letter). Exclusion Criteria: history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADLs History of COPD or oxygen dependence Pre-existing neurological disorders or dementia History of major head trauma Legal blindness or severe visual impairment Severe arthritis or other problems that limit passive ROM History of DVT or pulmonary embolism within 6 months Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Goodman Bowden, PhD MPT
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
MUSC Center for Rehabilitation Research in Neurologic Conditions
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
As a clinical trial, the details of this project will be entered into ClinicalTrials.gov. Clinical data from assessment sessions will be recorded on hard copies (stored in a locked file cabinet in the Ralph H. Johnson VAMC rehabilitation research space) and entered into a RedCAP electronic database by the project coordinator immediately after each session. These data will be de-identified for further analysis. Only the PI will only have access to de-identified data. Gait data will be analyzed using a custom MATLAB program, automatically populating a LabView Data Viewer from which customized data may be retrieved. The research coordinator will check the data entry, and pool all data into a group-wide de-identified spreadsheet. All data from training sessions will also be analyzed and stored using an automated MATLAB program. All electronic data will be stored on a secure server that is backed-up nightly.
IPD Sharing Time Frame
Completion of all study Aims. De-identified data set will be available for other investigators and registered in the NIH-supported registry.

Learn more about this trial

Incline Training to Personalize Motor Control Interventions After Stroke

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