Traumatic Brain InjuryTBINCT02339220
The Brave Initiative: Bringing Rehabilitation to American Veterans in an Enriched Environment
A study testing Constraint-Induced Movement Therapy (CIMT), Lakeshore Enriched Fitness Training (LEFT) and standard Transfer Package (sTP) in people with Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine the value of Constraint-Induced Movement therapy (CIMT) for improving motor function and general fitness in adults with subacute and chronic traumatic brain injury (TBI), particularly TBI acquired during active military duty, in comparison to a Lakeshore Enriched Fitness… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Constraint-Induced Movement Therapy (CIMT), Lakeshore Enriched Fitness Training (LEFT) and standard Transfer Package (sTP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 24 Apr 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor criteria will be made using an impairment-level system for characterizing the severity of an upper-extremity (UE) motor deficit based on Active Range of Motion (AROM). All UE motor criteria determinations will be made with the subject sitting. The more-affected forearm will be resting on a supporting surface (e.g. arm of chair) to allow for maximum wrist flexion with gravity. This study will treat patients at levels of Grade 2 (mild/moderate impairment) and Grade 3 (moderate impairment).
- The minimum motor criterion (MMC) for inclusion in Grade 3 (moderate impairment) will be ability to:
- Extend against gravity at least 10 degrees at the wrist from a fully flexed starting position
- Extend two or more fingers at least 10 degrees at the metacarpophalangeal (MP) joint and either the proximal or distal interphalangeal (IP) joints
- Extend or abduct the thumb at least 10 degrees
- Extend the elbow at least 20 degrees from a 90 degree flexed starting position
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- Flex and abduct the shoulder at least 45 degrees
- The MMC for inclusion in Grade 2 (mild/moderate impairment) will be ability to:
- Extend against gravity at least 20 degrees at the wrist from a fully flexed starting position
- Extend all fingers at least 10 degrees at the MP joint and either the proximal or distal IP joints
- Extend or abduct the thumb at least 10 degrees
- Extend the elbow at least 20 degrees from a 90 degree flexed starting position
- Flex and abduct the shoulder at least 45 degrees
- Additionally, subjects must have substantially reduced use of the extremity in the activities of daily living as indicated by a score of less than 2.5 on the Motor Activity Log (MAL).
- Note: Each movement described above must be repeated 3 times in 1 minute.
Who cannot join
- Those < 3 months post-TBI.
- Excessive UE spasticity.
- Insufficient stamina to carry out the requirements of the therapy (based on clinical judgment).
- Medication (including psychoactive substances) will not be exclusionary except in the following cases: (If subjects are on other medications, the medications will be recorded and the possible effect on treatment outcome will be analyzed separately)
- Participation in any experimental drug field study
- Botox injections to the more-affected UE less than 3 months prior to participation
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- Baclofen or Dantrium taken orally at the time of study
- Mini-Mental Status Exam (MMSE) score below 20.
- Concurrent participation in any formal physical rehabilitation program or clinical trial.
- Excessive pain in any joint of the more-affected extremity that could limit ability to cooperate with the intervention (based on clinical judgment).
- Serious, uncontrolled medical problems (e.g., cardiovascular, severe rheumatoid arthritis, serious joint deformity of arthritic origin, symptomatic cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, uncontrolled epilepsy) as judged by the Medical Director.
- Other neurological or musculoskeletal conditions affecting UE function.
- Unable to read or speak English.
- Inadequate communication skills, i.e., not able to reliably understand questions or not able to express needs or report own behavior, to participate in study based on clinical judgment.
- Substantial use of the more-affected arm in daily life as reflected by a Motor Activity Log score > 2.5.
- Pain that interferes with use of the more-affected arm based on clinical judgment.
- A positive pregnancy test will exclude participants from MRI scanning, but would not exclude them from clinical treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Harnessing Neuroplasticity to Promote Rehabilitation: Constraint-Induced (CI) Therapy for Traumatic Brain Injury (TBI)
The purpose of this study is to determine the value of Constraint-Induced Movement therapy (CIMT) for improving motor function and general fitness in adults with subacute and chronic traumatic brain injury (TBI), particularly TBI acquired during active military duty, in comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the effect of a set of enhanced versus "standard" procedures for transferring therapeutic gains from treatment setting to everyday life. Lastly, this study will determine whether any therapeutic effects observed are correlated with neuroplastic white matter or grey matter changes.
Read the detailed description
The proposed project is a prospective, randomized, controlled, single-blind study comparing the motor improvements resulting from Constraint-Induced Movement Therapy (CIMT) and Lakeshore Enriched Fitness Training (LEFT) for traumatic brain injury (TBI) in veterans and civilians. Over the course of two years, there will be a total of 80 subjects randomly assigned to 4 conditions. Treatment, testing, and follow-up testing will be carried out in the first 3 grant years and the 1-year follow-up will be completed in the fourth year. Clinical testing will be conducted at pre-treatment, post-treatment, and 1-year follow-up. Longitudinal neuroimaging studies to determine the treatment change in white matter, grey matter, and functional brain connectivity will be carried out across the above-noted time points by different diffusion tensor imaging (DTI) analysis variants, voxel-based morphometry (VBM) analysis of structural magnetic resonance imaging (MRI) scans, analysis of resting state functional MRI (fMRI), and analysis of fMRI during hand movement.
The 80 study participants will be randomly assigned in equal numbers to 1 of 4 arms: CIMT with Standard Transfer Package (sTP), CIMT with Enhanced Transfer Package (eTP), LEFT with sTP or LEFT with eTP. Forty volunteers will be tested on average per year. The patients will be classified into mild/moderate (Grade 2) and moderate motor deficits (Grades 3); a classification made at the impairment level based on standard active range of motion (AROM) criteria (further elaborated in "Eligibility Criteria").
The primary clinical outcome will be pre- to post-treatment change in a measure of use of the more-affected arm in daily life known as the Motor Activity Log. It is described in the outcomes section. As noted above, the response of the brain to the interventions will be examined using structural grey matter MRI analysis, DTI, and fMRI during resting state and during arm movement.
Each participant will have the option of being accompanied by a caregiver (travel and living expenses paid for by the project). The caregiver will be asked to complete the MAL independently of the participant. The same questionnaire administered to the patient will be administered to the caregiver. In addition, the caregiver will be shown how to help the patient carry out the home practice exercises so that they can do this during treatment and afterwards (if they remain in close contact with the participant).
- Conditions
- Traumatic Brain Injury
- Being tested
- Constraint-Induced Movement Therapy (CIMT), Lakeshore Enriched Fitness Training (LEFT), standard Transfer Package (sTP), enhanced Transfer Package (eTP)
- Keywords
- Constraint-Induced Movement Therapy, Physical Therapy, Rehabilitation, Occupational Therapy, Fitness Training, Recovery of Function, Neuroplasticity, Exercise Therapy, Brain Injuries, Traumatic Brain Injury, Physical Therapy Modalities, Neuroimaging
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement Therapy (CIMT)Behavioural
Also called CI therapy
Constraint-Induced Movement Therapy (CIMT) is a form of physical rehabilitation based on basic research in behavioral psychology and behavioral neuroscience. The therapy will be given on an outpatient basis for 3.5 hours/day for 10 consecutive weekdays. This treatment has four components: 1. intensive training in use of the more-affected arm; 2. organization of this training following shaping principles, which involve frequent positive feedback and progressively increasing the demand of the task in small increments; 3. discouraging use of the less-affected arm by placing the hand in a padded safety mitt, and 4. a set of behavioral procedures, known as the Transfer Package, for transferring gains from the treatment to real-world setting. In this study, two forms of the Transfer Package, standard and enhanced, will be used and form a separate factor (see below).
Lakeshore Enriched Fitness Training (LEFT)Behavioural
This treatment will given on an outpatient basis for 3.5 hours per day for 10 consecutive weekdays. It will consist of the following components: general fitness exercises (largely lower extremity), sports and recreation (land and water-based); adapted Yoga; breathing exercises and postural control, movement to music, massage therapy, meditation and Progressive Muscle Relaxation (PMR).
standard Transfer Package (sTP)Behavioural
This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. The sTP is a set of behavioral procedures for transferring gains from the treatment setting to real-world. The procedures when the sTP is applied to CIMT include negotiating a behavioral contract with the patient and caregiver, when available, about use of each arm during the treatment period, keeping a daily diary on arm use, completing a structured interview about use of the more-affected arm in daily, problem solving about perceived barriers to use of the more-affected arm outside the treatment setting during treatment, and four weekly follow-up phone calls to assess use of the more-affected arm and problem solve about any remaining barriers perceived to its use. The sTP when applied to the LEFT intervention will have parallel components that target engagement in fitness activities and overcoming perceived barriers to fitness in the home.
enhanced Transfer Package (eTP)Behavioural
This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. It is an enhanced form of the sTP. The enhancements include a computerized version of the daily diary, cues to be placed in patients' homes to prompt engagement in desired activities, and additional follow-up phone calls.
| Study group | Role | What they receive |
|---|---|---|
| Standard CI Therapy Group | Experimental | This group will receive Constraint-Induced Movement Therapy (CIMT) with the Standard Transfer Package (sTP). Receives: Behavioral: Constraint-Induced Movement Therapy (CIMT); Behavioral: standard Transfer Package (sTP) |
| Enhanced CI Therapy Group | Experimental | This group will receive CIMT with the enhanced Transfer Package (eTP). Receives: Behavioral: Constraint-Induced Movement Therapy (CIMT); Behavioral: enhanced Transfer Package (eTP) |
| Standard Fitness Training Group | Active comparator | This group will receive Lakeshore Enriched Fitness Training (LEFT) with the standard Transfer Package (sTP). Receives: Behavioral: Lakeshore Enriched Fitness Training (LEFT); Behavioral: standard Transfer Package (sTP) |
| Enhanced Fitness Training Group | Active comparator | This group will receive LEFT with the enhanced Transfer Package (eTP) Receives: Behavioral: Lakeshore Enriched Fitness Training (LEFT); Behavioral: enhanced Transfer Package (eTP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log
The Motor Activity Log (MAL) is a structured interview intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting.
Measured: From baseline to 19 days
Secondary outcomes (5)
Accelerometry
Accelerometers are devices that monitor movement. Here, they will be worn on the wrist and measure amount of arm movement and overall physical activity.
Measured: From baseline to 19 days
Accelerometry
Accelerometers are devices that monitor movement. Here, they will be worn on the wrist and measure amount of arm movement and overall physical activity.
Measured: From baseline to 12-months
Motor Activity Log
See description of MAL under primary outcome measure.
Measured: From baseline to 12-months
Six-Minute Walk/Push Wheelchair Test
This is a standard test of endurance and physical fitness. The distance walked or wheelchair is pushed in 6 minutes is measured.
Measured: From baseline to 19 days
Six-Minute Walk/Push Wheelchair Test
This is a standard test of endurance and physical fitness. The distance walked or wheelchair is pushed in 6 minutes is measured.
Measured: From baseline to 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startSep 2016
- Primary completionJan 2018
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Gitendra Uswatte, University of Alabama at Birmingham
- Investigators
- Edward Taub, Ph.D., Principal investigator, CI Therapy Research Group and Taub Training Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339220
- Sponsor's protocol ID
- PT130232
- Acronym
- TBI
- Status last verified
- Nov 2023
- First submitted
- 8 Jan 2015
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared via FITBIR site after trial has been unblinded and key outcome papers have been published.
Publications
Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
PubMed 8466415Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006 Apr;37(4):1045-9. doi: 10.1161/01.STR.0000206463.66461.97. Epub 2006 Mar 2.
PubMed 16514097Shaw SE, Morris DM, Uswatte G, McKay S, Meythaler JM, Taub E. Constraint-induced movement therapy for recovery of upper-limb function following traumatic brain injury. J Rehabil Res Dev. 2005 Nov-Dec;42(6):769-78. doi: 10.1682/jrrd.2005.06.0094.
PubMed 16680614Morris DM, Taub E, Mark VW, Liu W, Brenner L, Pickett T, Stearns-Yoder K, Bishop-McKay S, Taylor A, Reder L, Adams T, Rimmer J, Dew D, Szaflarski J, Womble B, Stevens L, Rothman D, Uswatte G. Protocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit: The Bringing Rehabilitation to American Veterans Everywhere Project. J Head Trauma Rehabil. 2019 Jul/Aug;34(4):268-279. doi: 10.1097/HTR.0000000000000460.
PubMed 30608308
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Neuroplasticity to Promote Rehabilitation: Constraint-Induced (CI) Therapy for Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT02339220
- Acronym / sponsor ID
- TBI / PT130232
- Conditions
- Traumatic Brain Injury
- Keywords
- Constraint-Induced Movement Therapy, Physical Therapy, Rehabilitation, Occupational Therapy, Fitness Training, Recovery of Function, Neuroplasticity, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 15 Jan 2015 (estimated)
- 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 determine the value of Constraint-Induced Movement therapy (CIMT) for improving motor function and general fitness in adults with subacute and chronic traumatic brain injury (TBI), particularly TBI acquired during active military duty, in comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the effect of a set of enhanced versus "standard" procedures for transferring therapeutic gains from treatment setting to everyday life. Lastly, this study will determine whether any therapeutic effects observed are correlated with neuroplastic white matter or grey matter changes.
Detailed description
The proposed project is a prospective, randomized, controlled, single-blind study comparing the motor improvements resulting from Constraint-Induced Movement Therapy (CIMT) and Lakeshore Enriched Fitness Training (LEFT) for traumatic brain injury (TBI) in veterans and civilians. Over the course of two years, there will be a total of 80 subjects randomly assigned to 4 conditions. Treatment, testing, and follow-up testing will be carried out in the first 3 grant years and the 1-year follow-up will be completed in the fourth year. Clinical testing will be conducted at pre-treatment, post-treatment, and 1-year follow-up. Longitudinal neuroimaging studies to determine the treatment change in white matter, grey matter, and functional brain connectivity will be carried out across the above-noted time points by different diffusion tensor imaging (DTI) analysis variants, voxel-based morphometry (VBM) analysis of structural magnetic resonance imaging (MRI) scans, analysis of resting state functional MRI (fMRI), and analysis of fMRI during hand movement.
The 80 study participants will be randomly assigned in equal numbers to 1 of 4 arms: CIMT with Standard Transfer Package (sTP), CIMT with Enhanced Transfer Package (eTP), LEFT with sTP or LEFT with eTP. Forty volunteers will be tested on average per year. The patients will be classified into mild/moderate (Grade 2) and moderate motor deficits (Grades 3); a classification made at the impairment level based on standard active range of motion (AROM) criteria (further elaborated in "Eligibility Criteria").
The primary clinical outcome will be pre- to post-treatment change in a measure of use of the more-affected arm in daily life known as the Motor Activity Log. It is described in the outcomes section. As noted above, the response of the brain to the interventions will be examined using structural grey matter MRI analysis, DTI, and fMRI during resting state and during arm movement.
Each participant will have the option of being accompanied by a caregiver (travel and living expenses paid for by the project). The caregiver will be asked to complete the MAL independently of the participant. The same questionnaire administered to the patient will be administered to the caregiver. In addition, the caregiver will be shown how to help the patient carry out the home practice exercises so that they can do this during treatment and afterwards (if they remain in close contact with the participant).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard CI Therapy Group | Experimental | Behavioral: Constraint-Induced Movement Therapy (CIMT), Behavioral: standard Transfer Package (sTP)This group will receive Constraint-Induced Movement Therapy (CIMT) with the Standard Transfer Package (sTP). |
| Enhanced CI Therapy Group | Experimental | Behavioral: Constraint-Induced Movement Therapy (CIMT), Behavioral: enhanced Transfer Package (eTP)This group will receive CIMT with the enhanced Transfer Package (eTP). |
| Standard Fitness Training Group | Active comparator | Behavioral: Lakeshore Enriched Fitness Training (LEFT), Behavioral: standard Transfer Package (sTP)This group will receive Lakeshore Enriched Fitness Training (LEFT) with the standard Transfer Package (sTP). |
| Enhanced Fitness Training Group | Active comparator | Behavioral: Lakeshore Enriched Fitness Training (LEFT), Behavioral: enhanced Transfer Package (eTP)This group will receive LEFT with the enhanced Transfer Package (eTP) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Motor criteria will be made using an impairment-level system for characterizing the severity of an upper-extremity (UE) motor deficit based on Active Range of Motion (AROM). All UE motor criteria determinations will be made with the subject sitting. The more-affected forearm will be resting on a supporting surface (e.g. arm of chair) to allow for maximum wrist flexion with gravity. This study will treat patients at levels of Grade 2 (mild/moderate impairment) and Grade 3 (moderate impairment).
- The minimum motor criterion (MMC) for inclusion in Grade 3 (moderate impairment) will be ability to:
- The MMC for inclusion in Grade 2 (mild/moderate impairment) will be ability to:
- Additionally, subjects must have substantially reduced use of the extremity in the activities of daily living as indicated by a score of less than 2.5 on the Motor Activity Log (MAL).
- Note: Each movement described above must be repeated 3 times in 1 minute.
Key exclusion criteria (17 listed)
- Those < 3 months post-TBI.
- Excessive UE spasticity.
- Insufficient stamina to carry out the requirements of the therapy (based on clinical judgment).
- Medication (including psychoactive substances) will not be exclusionary except in the following cases: (If subjects are on other medications, the medications will be recorded and the possible effect on treatment outcome will be analyzed separately)
- Mini-Mental Status Exam (MMSE) score below 20.
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 |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT)Also: CI therapyConstraint-Induced Movement Therapy (CIMT) is a form of physical rehabilitation based on basic research in behavioral psychology and behavioral neuroscience. The therapy will be given on an outpatient basis for 3.5 hours/day for 10 consecutive weekdays. This treatment has four components: 1. intensive training in use of the more-affected arm; 2. organization of this training following shaping principles, which involve frequent positive feedback and progressively increasing the demand of the task in small increments; 3. discouraging use of the less-affected arm by placing the hand in a padded safety mitt, and 4. a set of behavioral procedures, known as the Transfer Package, for transferring gains from the treatment to real-world setting. In this study, two forms of the Transfer Package, standard and enhanced, will be used and form a separate factor (see below). | Behavioural | Enhanced CI Therapy Group, Standard CI Therapy Group |
| Lakeshore Enriched Fitness Training (LEFT)This treatment will given on an outpatient basis for 3.5 hours per day for 10 consecutive weekdays. It will consist of the following components: general fitness exercises (largely lower extremity), sports and recreation (land and water-based); adapted Yoga; breathing exercises and postural control, movement to music, massage therapy, meditation and Progressive Muscle Relaxation (PMR). | Behavioural | Enhanced Fitness Training Group, Standard Fitness Training Group |
| standard Transfer Package (sTP)This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. The sTP is a set of behavioral procedures for transferring gains from the treatment setting to real-world. The procedures when the sTP is applied to CIMT include negotiating a behavioral contract with the patient and caregiver, when available, about use of each arm during the treatment period, keeping a daily diary on arm use, completing a structured interview about use of the more-affected arm in daily, problem solving about perceived barriers to use of the more-affected arm outside the treatment setting during treatment, and four weekly follow-up phone calls to assess use of the more-affected arm and problem solve about any remaining barriers perceived to its use. The sTP when applied to the LEFT intervention will have parallel components that target engagement in fitness activities and overcoming perceived barriers to fitness in the home. | Behavioural | Standard CI Therapy Group, Standard Fitness Training Group |
| enhanced Transfer Package (eTP)This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. It is an enhanced form of the sTP. The enhancements include a computerized version of the daily diary, cues to be placed in patients' homes to prompt engagement in desired activities, and additional follow-up phone calls. | Behavioural | Enhanced CI Therapy Group, Enhanced Fitness Training Group |
Primary outcome
Motor Activity Log
Time frame: From baseline to 19 days
The Motor Activity Log (MAL) is a structured interview intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting.
5 secondary outcomes
Accelerometry
Time frame: From baseline to 19 days
Accelerometry
Time frame: From baseline to 12-months
Motor Activity Log
Time frame: From baseline to 12-months
Six-Minute Walk/Push Wheelchair Test
Time frame: From baseline to 19 days
Six-Minute Walk/Push Wheelchair Test
Time frame: From baseline to 12-months
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 6 Dec 2023.
- Background: PubMed 8466415Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
- Background: PubMed 16514097Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006 Apr;37(4):1045-9. doi: 10.1161/01.STR.0000206463.66461.97. Epub 2006 Mar 2.
- Background: PubMed 16680614Shaw SE, Morris DM, Uswatte G, McKay S, Meythaler JM, Taub E. Constraint-induced movement therapy for recovery of upper-limb function following traumatic brain injury. J Rehabil Res Dev. 2005 Nov-Dec;42(6):769-78. doi: 10.1682/jrrd.2005.06.0094.
- Derived from this study: PubMed 30608308Morris DM, Taub E, Mark VW, Liu W, Brenner L, Pickett T, Stearns-Yoder K, Bishop-McKay S, Taylor A, Reder L, Adams T, Rimmer J, Dew D, Szaflarski J, Womble B, Stevens L, Rothman D, Uswatte G. Protocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit: The Bringing Rehabilitation to American Veterans Everywhere Project. J Head Trauma Rehabil. 2019 Jul/Aug;34(4):268-279. doi: 10.1097/HTR.0000000000000460.
- Individual participant dataSharing planned: Yes. Data will be shared via FITBIR site after trial has been unblinded and key outcome papers have been published.
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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.
Edward Taub, Ph.D. principal investigator
CI Therapy Research Group and Taub Training Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-Induced Movement Therapy (CIMT), Lakeshore Enriched Fitness Training (LEFT) and standard Transfer Package (sTP) in people with Traumatic Brain Injury, run by University of Alabama at Birmingham 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 15 inclusion and 17 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 6 Dec 2023. 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?
Motor Activity Log (time frame: From baseline to 19 days). 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 NCT02339220, which also lists 4 linked publications.
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 6 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.