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

NCT ID: NCT04063228

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2020-06-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Group Type: ACTIVE_COMPARATOR

Simple Skill Group

Intervention Type: OTHER

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

Simple Skill Group

Group Type: ACTIVE_COMPARATOR

Complex Skill Group

Intervention Type: 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).

Interventions

Simple Skill Group

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

Intervention Type: OTHER

Complex Skill Group

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Estelle Gallo, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

17-00695

Identifier Type: -

Identifier Source: org_study_id