High Level Mobility Training in Ambulatory Patients With... | NCT04063228

Studies
High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury

NCT04063228

Sponsor

NYU Langone Health

Status

Terminated

Last Update Posted

Aug 11, 2020Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Neurological Injury

Interventions

Simple Skill Group
Complex Skill Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of resources

Expanded Access Info

Start Date

Jun 17, 2019Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Aug 19, 2019

First Submission Date that Met QC Criteria

Aug 19, 2019

First Posted Date

Aug 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2020

Last Update Posted Date

Aug 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of care	Active Comparator		Other: Simple Skill Group
Simple Skill Group	Active Comparator		Other: Complex Skill Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simple Skill Group	Other	will practice the following skills as needed: bed mobility, transfer, walking, and stairs.	Standard of care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recruitment Feasibility	measured by the number of individuals who consent to participate.	2 Years
Training feasibility	Measured by the number of sessions attended by each participant.	2 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009422	Nervous System Diseases
D014947	Wounds and Injuries