Neurological InjuryNCT04063228
High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
A study testing Simple Skill Group and Complex Skill Group in people with Neurological Injury, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neurological Injury
- What is being tested?
- Simple Skill Group and Complex Skill Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Simple Skill Group, Complex Skill Group
- Keywords
- non-progressive central neurological injury
- Medical subject headings
- Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple Skill GroupOther
will practice the following skills as needed: bed mobility, transfer, walking, and stairs.
Complex Skill GroupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Not described Receives: Other: Simple Skill Group |
| Simple Skill Group | Active comparator | Not described Receives: Other: Complex Skill Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
measured by the number of individuals who consent to participate.
Measured: 2 Years
Training feasibility
Measured by the number of sessions attended by each participant.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start17 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estelle Gallo, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063228
- Sponsor's protocol ID
- 17-00695
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
- ClinicalTrials.gov ID
- NCT04063228
- Acronym / sponsor ID
- 17-00695
- Conditions
- Neurological Injury
- Keywords
- non-progressive central neurological injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Simple Skill Group |
| Simple Skill Group | Active comparator | Other: Complex Skill Group |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple Skill Groupwill practice the following skills as needed: bed mobility, transfer, walking, and stairs. | Other | Standard of care |
| Complex Skill GroupThe 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). | Other | Simple Skill Group |
Primary outcome
Recruitment Feasibility
Time frame: 2 Years
measured by the number of individuals who consent to participate.
Training feasibility
Time frame: 2 Years
Measured by the number of sessions attended by each participant.
Results and safety
The study was stopped early (reason given: Lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Related trials for Neurological Injury
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Spinal Cord Injuries or Similar Neurological Weakness
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Olfactory Cell Transplantation and Intensive Rehabilitation to Repair Chronic Spinal Cord Injury
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Estelle Gallo, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple Skill Group and Complex Skill Group in people with Neurological Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.