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

Neurological Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04063228
• Other study ID #: 17-00695
• Status: Terminated
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurological Injury
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Other:
• Simple Skill Group
will practice the following skills as needed: bed mobility, transfer, walking, and stairs.
• 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).

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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