Back to resultsHigh Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
Primary Purpose
Neurological Injury
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simple Skill Group
Complex Skill Group
Sponsored by
About this trial
This is an interventional treatment trial for Neurological Injury focused on measuring non-progressive central neurological injury
Eligibility Criteria
Inclusion Criteria:
- Referred to physical therapy with an Acquired Non-Progressive Central Neurological Injury (traumatic brain injury, stroke, brain tumor, spinal cord injury) for 3 months or more
- capacity to consent
- ability to read and write English at the sixth grade level
- able to walk twenty meter without physical assistance or an assistive device, however they can use a brace.
- self-selected gait speed of 0.6 m/s or greater when performing 10 meter walk test.
Exclusion Criteria:
- Adults subjects diagnosed with a progressive central or peripheral neurological disorder or an acute non progressive central neurological disorder (less than 3 months)
- Subjects who require physical assistance or an assistive device to walk twenty meters or demonstrate self-selected gait speed less than 0.6 m/s
- Subjects who are already able to run independently in the community
- Participants who are unable to complete the 12 physical therapy visits at prescribed skill level as established by protocol
- Participants who reports >4/10 on NPRS with lower extremity weight bearing.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard of care
Simple Skill Group
Arm Description
Outcomes
Primary Outcome Measures
Recruitment Feasibility
measured by the number of individuals who consent to participate.
Training feasibility
Measured by the number of sessions attended by each participant.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04063228
Brief Title
High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
Official Title
High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of resources
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Brain injuries are a significant cause of loss of movement. It has been shown that physical therapy can help patients to regain movements. The purpose of this study is to see if it is possible to perform a new exercise program that will help patients regain movement. This new exercise program will involve practicing walking, stairs, jumping and running. Participation in this study will involve physical therapy 1 to 2 times a week for 12 visits over 6 to 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Injury
Keywords
non-progressive central neurological injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Title
Simple Skill Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Simple Skill Group
Intervention Description
will practice the following skills as needed: bed mobility, transfer, walking, and stairs.
Intervention Type
Other
Intervention Name(s)
Complex Skill Group
Intervention Description
The program will consist of interventions at the impairments level with an emphasis on core strengthening, functional lower extremity strengthening, balance and endurance training, and at the skill acquisition level. Participants will learn pre-running skills (walking, stairs with handrail, walking backward, walking over obstacles, walking on toes, stairs without handrail, bounding), running skills (force generation in vertical plane: hopping, alternate hopping, running in place in gravity minimized position and against gravity; force generation in horizontal plane: bounding, alternate bounding, open chain movement for swing phase, running) and post running skills (running forward, backward, sideways, skipping, hopping).
Primary Outcome Measure Information:
Title
Recruitment Feasibility
Description
measured by the number of individuals who consent to participate.
Time Frame
2 Years
Title
Training feasibility
Description
Measured by the number of sessions attended by each participant.
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referred to physical therapy with an Acquired Non-Progressive Central Neurological Injury (traumatic brain injury, stroke, brain tumor, spinal cord injury) for 3 months or more
capacity to consent
ability to read and write English at the sixth grade level
able to walk twenty meter without physical assistance or an assistive device, however they can use a brace.
self-selected gait speed of 0.6 m/s or greater when performing 10 meter walk test.
Exclusion Criteria:
Adults subjects diagnosed with a progressive central or peripheral neurological disorder or an acute non progressive central neurological disorder (less than 3 months)
Subjects who require physical assistance or an assistive device to walk twenty meters or demonstrate self-selected gait speed less than 0.6 m/s
Subjects who are already able to run independently in the community
Participants who are unable to complete the 12 physical therapy visits at prescribed skill level as established by protocol
Participants who reports >4/10 on NPRS with lower extremity weight bearing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Estelle Gallo, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
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