Brain Injury Traumatic MildNCT03478059
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
A study testing Cognitive and Motor Dual-task Intervention in people with Brain Injury Traumatic Mild and Concussion, Brain, run by Allina Health System at 1 site in United States.
Trial summary
This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury Traumatic Mild, Concussion, Brain
- What is being tested?
- Cognitive and Motor Dual-task Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to 30 Jun 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-34 years of age.
- Strong history of athletic participation including high school and collegiate varsity and/or club sports
- Current sport or recreational sport participation at least 3 days per week
- Willingness to participate in 3 times a week 60 minute exercise program conducted at Courage Kenny Research Center (CKRC).
- Adults aged 18-50 years of age.
- Self-report of some consistent exercise or activity a minimum of 2-3 days per week.
- 3 weeks to 24 months post most recent concussion seeking treatment at Courage Kenny Rehabilitation Institute (CKRI) clinics
- Willingness to participate in 3 times a week 60 minute exercise program conducted at CKRC.
Who cannot join
- History of concussion.
- History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson's Disease, etc.) interfering with subject's ability to exercise
- Unwilling to exercise.
- At risk for cardiopulmonary disease as defined by the American College of Sports Medicine.
- Active medical contraindications by self-report after explanation of dual-task exercise program.
- Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis) by self-report.
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- History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson Disease, etc.) interfering with subject's ability to exercise
- Unwilling to exercise.
- At risk for cardiopulmonary disease as defined by the American College of Sports Medicine.
- Active medical contraindications by self-report after explanation of dual-task exercise program,
- Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.
- Conditions
- Brain Injury Traumatic Mild, Concussion, Brain
- Being tested
- Cognitive and Motor Dual-task Intervention
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and Motor Dual-task InterventionBehavioural
The intervention will take place 3 times per week for 6 weeks (60 minutes/session) and employs motor and cognitive challenges. It is based on known motor and cognitive deficits after mTBI and is structured using a theoretical framework published in another domain of neurologic disease. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Each station will have 3 levels of difficulty with optional cognitive progressions. Subjects will spend 8 minutes at each station with a 2 minute transition/rest period between stations and will be progressed in motor and cognitive difficulty as able.
| Study group | Role | What they receive |
|---|---|---|
| Mild Traumatic Brain Injury | Experimental | 60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI.
Subjects with mTBI residuals will be gently progressed through exercise stations in an individually tailored fashion. Receives: Behavioral: Cognitive and Motor Dual-task Intervention |
| Healthy Control | Other | 60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI.
In addition to providing comparison data, the healthy control, athletic 18-34 year old subjects will be used to identify levels and intensity of progressions of dual-task training stations appropriate for highly trained athletes and military personnel recovering from concussion. Receives: Behavioral: Cognitive and Motor Dual-task Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak velocity turns during Instrumented Stand and Walk Test
Change in peak velocity during 180 degree turns during Instrumented Stand and Walk Test in single task (ST) and dual-task (DT) conditions. DT condition involves grid memorization task.
Measured: At baseline and after 6 weeks of intervention
Secondary outcomes (13)
Change in peak turning velocity during walking a custom turning course
Change in peak turning velocity during walking a custom turning course in ST and DT conditions.
Measured: At baseline and after 6 weeks of intervention
Change in peak turning velocity during running an agility course
Change in peak turning velocity during running an agility course in ST and DT conditions.
Measured: At baseline and after 6 weeks of intervention
Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance
Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance in ST and DT conditions.
Measured: At baseline and after 6 weeks of intervention
Change in Beck Depression Inventory-II
Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression.
Measured: At baseline and after 6 weeks of intervention
Change in Beck Anxiety Inventory
Change in Beck Anxiety Inventory: 21 item self-administered questionnaire measuring subjective, somatic, or panic-related symptoms of anxiety.
Measured: At baseline and after 6 weeks of intervention
Change in Patient-specific Functional Scale
Change in Patient-specific Functional Scale -quantifies the amount of functional limitation secondary to symptoms in up to 3 activities that are relevant to the individual patient. 0 to 10 scale, where 0 = unable to perform activity and 10 = able to perform activity at same level as before injury or problem.
Measured: At baseline and after 6 weeks of intervention
Change in Neurobehavioral Symptom Inventory (NSI)
Change in Neurobehavioral Symptom Inventory (NSI): Self-report of residual symptoms "in last 2 weeks", a measure of post-TBI symptom severity, 0-4 scale on 22 symptom questions.
Measured: At baseline and after 6 weeks of intervention
Rey Auditory Verbal Learning Test Score
Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)
Measured: At baseline
Comprehensive Trails Making Test Score
Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed
Measured: Baseline
Verbal Fluency Test Score
Verbal Fluency which tests verbal ability and executive control
Measured: Baseline
NAB Digits Forward/Digits Backward Test Score
NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory
Measured: Baseline
Stroop Color-Word Test Score
Stroop Color-Word Test to evaluate sustained and selective attention as well as freedom from distractibility and inhibitory control.
Measured: Baseline
Wide Range Achievement Test-4 Reading Score
Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start31 Oct 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury Traumatic MildStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Weightman, Allina Health System
- Investigators
- Margaret M Weightman, PT, PhD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478059
- Sponsor's protocol ID
- CKMW-1701
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2018
- Last updated
- 30 Aug 2019
- 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 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
- ClinicalTrials.gov ID
- NCT03478059
- Acronym / sponsor ID
- CKMW-1701
- Conditions
- Brain Injury Traumatic Mild, Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Mar 2018 (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.
This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Traumatic Brain Injury | Experimental | Behavioral: Cognitive and Motor Dual-task Intervention60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Subjects with mTBI residuals will be gently progressed through exercise stations in an individually tailored fashion. |
| Healthy Control | Other | Behavioral: Cognitive and Motor Dual-task Intervention60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. In addition to providing comparison data, the healthy control, athletic 18-34 year old subjects will be used to identify levels and intensity of progressions of dual-task training stations appropriate for highly trained athletes and military personnel recovering from concussion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults aged 18-34 years of age.
- Strong history of athletic participation including high school and collegiate varsity and/or club sports
- Current sport or recreational sport participation at least 3 days per week
- Willingness to participate in 3 times a week 60 minute exercise program conducted at Courage Kenny Research Center (CKRC).
- Adults aged 18-50 years of age.
Key exclusion criteria (11 listed)
- History of concussion.
- History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson's Disease, etc.) interfering with subject's ability to exercise
- Unwilling to exercise.
- At risk for cardiopulmonary disease as defined by the American College of Sports Medicine.
- Active medical contraindications by self-report after explanation of dual-task exercise program.
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 |
|---|---|---|
| Cognitive and Motor Dual-task InterventionThe intervention will take place 3 times per week for 6 weeks (60 minutes/session) and employs motor and cognitive challenges. It is based on known motor and cognitive deficits after mTBI and is structured using a theoretical framework published in another domain of neurologic disease. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Each station will have 3 levels of difficulty with optional cognitive progressions. Subjects will spend 8 minutes at each station with a 2 minute transition/rest period between stations and will be progressed in motor and cognitive difficulty as able. | Behavioural | Healthy Control, Mild Traumatic Brain Injury |
Primary outcome
Change in peak velocity turns during Instrumented Stand and Walk Test
Time frame: At baseline and after 6 weeks of intervention
Change in peak velocity during 180 degree turns during Instrumented Stand and Walk Test in single task (ST) and dual-task (DT) conditions. DT condition involves grid memorization task.
13 secondary outcomes
Change in peak turning velocity during walking a custom turning course
Time frame: At baseline and after 6 weeks of intervention
Change in peak turning velocity during running an agility course
Time frame: At baseline and after 6 weeks of intervention
Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance
Time frame: At baseline and after 6 weeks of intervention
Change in Beck Depression Inventory-II
Time frame: At baseline and after 6 weeks of intervention
Change in Beck Anxiety Inventory
Time frame: At baseline and after 6 weeks of intervention
Change in Patient-specific Functional Scale
Time frame: At baseline and after 6 weeks of intervention
Change in Neurobehavioral Symptom Inventory (NSI)
Time frame: At baseline and after 6 weeks of intervention
Rey Auditory Verbal Learning Test Score
Time frame: At baseline
Comprehensive Trails Making Test Score
Time frame: Baseline
Verbal Fluency Test Score
Time frame: Baseline
NAB Digits Forward/Digits Backward Test Score
Time frame: Baseline
Stroop Color-Word Test Score
Time frame: Baseline
Wide Range Achievement Test-4 Reading Score
Time frame: Baseline
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 30 Aug 2019.
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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.
Margaret M Weightman, PT, PhD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and Motor Dual-task Intervention in people with Brain Injury Traumatic Mild and Concussion, Brain, run by Allina Health System 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 8 inclusion and 11 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 30 Aug 2019. 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 peak velocity turns during Instrumented Stand and Walk Test (time frame: At baseline and after 6 weeks of intervention). 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 30 Aug 2019.