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NCT04503473 · ClinicalTrials.gov registry record · NA
Locomotor Recovery Following Traumatic Brain Injury
A NA study of Traumatic Brain Injury (TBI), sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04503473: Completed NA study of Traumatic Brain Injury (TBI), sponsored by Indiana University.
NCT04503473 is a NA study of Traumatic Brain Injury (TBI) that has completed, run by Indiana University. The registered enrollment target is 17 participants, below the 49-participant average among 6 other Traumatic Brain Injury (TBI) trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04503473, a NA study of Traumatic Brain Injury (TBI), has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to investigate the effectiveness of two different walking training interventions on the recovery of strength, mobility, walking and other measures of health in individuals following traumatic brain injury. During this study, participants will aim to complete up to 15 training sessions over 4-5 weeks of each intervention with at least a 4 week break between interventions. Each training session will last approximately 1 hour, while testing sessions performed at the beginning and end of each intervention will last approximately 3-4 hours. Participation in this research study may last up to 6 months including screening and baseline testing. The possible benefits to participant from participation in this study include increased strength of the participants leg muscles and improved walking ability
Primary Outcome
Gait speed is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates. This measure will be performed by blinded assessors who do not participate in the training. Gait speed will be measured at self-selected speeds (SSS; instructions to "walk at normal comfortable pace") and fastest-possible speed (FS: "as fast as you safely can") using the Zeno Walkway (Protokinetics, Haverton, PA).
Conditions Studied
Interventions
- BEHAVIORAL High Intensity Stepping Training
- BEHAVIORAL Conventional Therapy
Study Locations (1)
Indiana
- Rehabilitation Hospital of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
What the finished NCT04503473 record still lists
NCT04503473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 49-participant average among 6 other Traumatic Brain Injury (TBI) trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Traumatic Brain Injury (TBI) appearing as the primary indexed condition, and to 2 interventions - of which High Intensity Stepping Training is the first listed.
NCT04503473 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04503473 about?
NCT04503473 is a clinical study titled "Locomotor Recovery Following Traumatic Brain Injury". The purpose of this study is to investigate the effectiveness of two different walking training interventions on the recovery of strength, mobility, walking and other measures of health in individuals following traumatic brain injury. During this study, participants will aim to complete up to 15 tra...
What is the current status of trial NCT04503473?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2020-08-01. Estimated completion is 2022-12-31.
What conditions does trial NCT04503473 study?
This clinical trial studies the following conditions: Traumatic Brain Injury (TBI).
What interventions are being tested in trial NCT04503473?
The interventions under investigation include: High Intensity Stepping Training (BEHAVIORAL), Conventional Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04503473?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04503473 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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