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

NCT04063228 | Terminated

• 1 other identifier: 17-00695
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Injury

Keywords

non-progressive central neurological injury

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Other: Simple Skill Group

Simple Skill Group

ACTIVE COMPARATOR

Other: Complex Skill Group

Interventions

Simple Skill Group OTHER

will practice the following skills as needed: bed mobility, transfer, walking, and stairs.

Standard of care

Complex Skill Group OTHER

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).

Simple Skill Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Trauma, Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries

Study Officials

• Estelle Gallo, MD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: June 17, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

US (1)