Traumatic Brain Injury (TBI)TBI_IUNCT04503473
Locomotor Recovery Following Traumatic Brain Injury
A study testing High Intensity Stepping Training and Conventional Therapy in people with Traumatic Brain Injury (TBI), run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- High Intensity Stepping Training and Conventional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 6 months post traumatic brain injury
- 18-75 years old
- ability to walk without physical assistance
- Self selected walking speed of 0.01-1.0 m/s
Who cannot join
- <18 years old
- >75 years old
- self selected walking speed of > 1.0 m/s
- < 3 months from botulinum toxin injection
- Above the knee brace
- Currently receiving physical therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
About this study
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
Read the detailed description
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with (> 6 Months) traumatic brain injury (TBI). The investigator will do this by building on our previous work directed towards identifying the essential exercise training parameters that maximize locomotor recovery. Consistent with principles of motor learning and exercise physiology, the investigator contend that certain training (i.e., dosage) parameters of physical rehabilitation, including the type (specificity) and amount of task practice, are critical to mobility outcomes following neurological injury. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of amount of task-specific practice in neurologic injury. Indeed, no studies have carefully controlled these training parameters during physical rehabilitation of patients with neurologic injury, and such interventions are rarely utilized in the clinical setting. Reasons for these knowledge gaps from other rehabilitation studies to patients with neurologic injury or lack of clinical implementation are unclear, but may be due to adherence to traditional rehabilitation theories. One concern is that practicing only stepping tasks reduces attention towards hallmark physical impairments following neurologic injury, such as loss of strength or postural stability, which are considered primary determinants of decreased mobility. Only a few studies have addressed whether providing only structured stepping training can mitigate these impairments without their explicit practice, but not in the neurologic injury population. A related concern is that focused stepping training without significant attention towards impairments or gait quality may exaggerate altered movement strategies, which could be reinforced with repeated practice. However, there is little data to suggest "worsening" of abnormal gait patterns following high intensity training. Rather, recent findings suggest patients demonstrate more normal kinematics. If focused task specific (i.e., stepping) training is to be applied clinically, participant must delineate its contributions towards improving locomotor function, and their effects on underlying impairments and gait kinematics.
Central hypotheses are that stepping training in TBI results in:1) greater locomotor gains as compared to non-specific interventions; 2) gains in selected impairments underlying gait dysfunction (i.e., strength and metabolic capacity and efficiency); and, 3) improvements in gait quality. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of specificity of rehabilitation training applied early-post-stroke. In this RCT, patients > 6 post-TBI will be allocated ≤ 15 sessions over approximately 4-5 weeks of high-intensity stepping training or conventional therapy. Importantly, training intensity will be held constant to account for this potential confounding factor. Blinded assessments will be performed prior to and following each training paradigm.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- High Intensity Stepping Training, Conventional Therapy
- Keywords
- Traumatic Brain Injury, TBI, Walking
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Stepping TrainingBehavioural
Also called HIT
The goals will be to maximize stepping activity at high intensities for 40 minutes per 1 hour session, with rest breaks as needed
Conventional Therapy: : Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions
Conventional TherapyBehavioural
Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Stepping Training | Experimental | The primary goal will be to perform continuous stepping while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). We will also record Ratings of Perceived Exertion (RPE) every 3-5 minutes, with goals of 15-18. Sessions will be divided into ~10 minute increments (~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing. Receives: Behavioral: High Intensity Stepping Training |
| Conventional Therapy | Active comparator | Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions. The type of therapeutic activities is based on published normative data of typical activities performed during clinical physical therapy sessions with focus on strengthening activities (25% of session); balance activities (25%); locomotor activities (25%), and combined stretching exercises (10-15%) and transfers (10-15%). Intensity of activities will be targeted at 30-40% of their HR reserve in attempts to maintain consistent intensities between training groups. Receives: Behavioral: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait speed
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).
Measured: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
Change in Endurance
Endurance 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 endurance will be tested using the 6MWT (m) with instructions similar to SSS to minimize fall risk.
Measured: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
Secondary outcomes (3)
Change in Strength
- Peak volitional strength - We will assess strength while subjects are seated in an adjustable height chair of a testing apparatus. Three trials of peak isometric volitional hip, knee and ankle torques will be determined bilaterally with significant verbal encouragement for 3-5 sec, and > 1 min duration between trials.
Measured: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 6 weeks
Change in gait quality
Gait kinematics: Lower limb kinematics will be collected using an 8-camera motion capture system and 3-dimensional movement of 1" reflective markers affixed to the pelvis/legs. Spatiotemporal metrics will be extracted from the data, with primary measures of peak speed, stride length, cadence. All measures will be compared between fastest speeds achieved at BSL and POST, and at POST speeds matched to BSL peak speed to allow kinematic comparisons while controlling for speeds.
Measured: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
Change in metabolic capacity
peak metabolic capacity will be observed during graded exercise testing on a treadmill wtih peak oxygen consumption
Measured: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Baseline characteristics and training parameters (steps, intensity parameters) will be compared between treatment groups using independent group comparisons. (ANOVA, Kruskal-Wallis, or Chi-squared tests as appropriate).
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- George Hornby, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503473
- Sponsor's protocol ID
- 1911962819
- Acronym
- TBI_IU
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2019
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Plawecki A, Henderson CE, Lotter JK, Shoger LH, Inks E, Scofield M, Voigtmann CJ, Katta-Charles S, Hornby TG. Comparative Efficacy of High-Intensity Training Versus Conventional Training in Individuals With Chronic Traumatic Brain Injury: A Pilot Randomized Controlled Study. J Neurotrauma. 2024 Apr;41(7-8):807-817. doi: 10.1089/neu.2023.0494. Epub 2024 Jan 25.
PubMed 38204184
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Recovery Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04503473
- Acronym / sponsor ID
- TBI_IU / 1911962819
- Conditions
- Traumatic Brain Injury (TBI)
- Keywords
- Traumatic Brain Injury, TBI, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Aug 2020 (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.
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
Detailed description
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with (> 6 Months) traumatic brain injury (TBI). The investigator will do this by building on our previous work directed towards identifying the essential exercise training parameters that maximize locomotor recovery. Consistent with principles of motor learning and exercise physiology, the investigator contend that certain training (i.e., dosage) parameters of physical rehabilitation, including the type (specificity) and amount of task practice, are critical to mobility outcomes following neurological injury. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of amount of task-specific practice in neurologic injury. Indeed, no studies have carefully controlled these training parameters during physical rehabilitation of patients with neurologic injury, and such interventions are rarely utilized in the clinical setting. Reasons for these knowledge gaps from other rehabilitation studies to patients with neurologic injury or lack of clinical implementation are unclear, but may be due to adherence to traditional rehabilitation theories. One concern is that practicing only stepping tasks reduces attention towards hallmark physical impairments following neurologic injury, such as loss of strength or postural stability, which are considered primary determinants of decreased mobility. Only a few studies have addressed whether providing only structured stepping training can mitigate these impairments without their explicit practice, but not in the neurologic injury population. A related concern is that focused stepping training without significant attention towards impairments or gait quality may exaggerate altered movement strategies, which could be reinforced with repeated practice. However, there is little data to suggest "worsening" of abnormal gait patterns following high intensity training. Rather, recent findings suggest patients demonstrate more normal kinematics. If focused task specific (i.e., stepping) training is to be applied clinically, participant must delineate its contributions towards improving locomotor function, and their effects on underlying impairments and gait kinematics.
Central hypotheses are that stepping training in TBI results in:1) greater locomotor gains as compared to non-specific interventions; 2) gains in selected impairments underlying gait dysfunction (i.e., strength and metabolic capacity and efficiency); and, 3) improvements in gait quality. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of specificity of rehabilitation training applied early-post-stroke. In this RCT, patients > 6 post-TBI will be allocated ≤ 15 sessions over approximately 4-5 weeks of high-intensity stepping training or conventional therapy. Importantly, training intensity will be held constant to account for this potential confounding factor. Blinded assessments will be performed prior to and following each training paradigm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Baseline characteristics and training parameters (steps, intensity parameters) will be compared between treatment groups using independent group comparisons. (ANOVA, Kruskal-Wallis, or Chi-squared tests as appropriate).
| Arm | Type | Receives |
|---|---|---|
| High Intensity Stepping Training | Experimental | Behavioral: High Intensity Stepping TrainingThe primary goal will be to perform continuous stepping while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). We will also record Ratings of Perceived Exertion (RPE) every 3-5 minutes, with goals of 15-18. Sessions will be divided into ~10 minute increments (~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing. |
| Conventional Therapy | Active comparator | Behavioral: Conventional TherapyParticipants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions. The type of therapeutic activities is based on published normative data of typical activities performed during clinical physical therapy sessions with focus on strengthening activities (25% of session); balance activities (25%); locomotor activities (25%), and combined stretching exercises (10-15%) and transfers (10-15%). Intensity of activities will be targeted at 30-40% of their HR reserve in attempts to maintain consistent intensities between training groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 6 months post traumatic brain injury
- 18-75 years old
- ability to walk without physical assistance
- Self selected walking speed of 0.01-1.0 m/s
Key exclusion criteria (6 listed)
- <18 years old
- >75 years old
- self selected walking speed of > 1.0 m/s
- < 3 months from botulinum toxin injection
- Above the knee brace
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 |
|---|---|---|
| High Intensity Stepping TrainingAlso: HITThe goals will be to maximize stepping activity at high intensities for 40 minutes per 1 hour session, with rest breaks as needed Conventional Therapy: : Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions | Behavioural | High Intensity Stepping Training |
| Conventional TherapyParticipants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions | Behavioural | Conventional Therapy |
Primary outcome
Change in Gait speed
Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
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).
Change in Endurance
Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
Endurance 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 endurance will be tested using the 6MWT (m) with instructions similar to SSS to minimize fall risk.
3 secondary outcomes
Change in Strength
Time frame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 6 weeks
Change in gait quality
Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
Change in metabolic capacity
Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Derived from this study: PubMed 38204184Plawecki A, Henderson CE, Lotter JK, Shoger LH, Inks E, Scofield M, Voigtmann CJ, Katta-Charles S, Hornby TG. Comparative Efficacy of High-Intensity Training Versus Conventional Training in Individuals With Chronic Traumatic Brain Injury: A Pilot Randomized Controlled Study. J Neurotrauma. 2024 Apr;41(7-8):807-817. doi: 10.1089/neu.2023.0494. Epub 2024 Jan 25.
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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.
George Hornby, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Stepping Training and Conventional Therapy in people with Traumatic Brain Injury (TBI), run by Indiana University 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 May 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Gait speed (time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks). 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?
On the ClinicalTrials.gov record for NCT04503473, which also lists 1 linked publication.
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 2 May 2024.