Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
Primary Purpose
Brain Concussion
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual Neuromuscular/Dual-Task Training
Sponsored by
About this trial
This is an interventional treatment trial for Brain Concussion
Eligibility Criteria
Inclusion Criteria:
- 18-35 years of age at the time of enrollment
- Mild TBI or concussion diagnosis by a physician
- Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment
- Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire [GPAQ]) (Cleland et al., 2014; Keating et al., 2019)
- Access to a smartphone for app download
Exclusion Criteria:
- Moderate or severe TBI
- Pre-injury neurological disorder
- Abnormal brain imaging findings (if performed as a part of routine care)
- Previous TBI (mild/moderate/severe) <12 months prior to enrollment other than the current injury for which they are being seen
Sites / Locations
- University of Colorado DenverRecruiting
- Brooke Army Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Neuromuscular/Dual-Task Training
Standard-of-care
Arm Description
The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks.
Participants will be provided routine instructions related to physical activity and rehabilitation exercises
Outcomes
Primary Outcome Measures
Injury rate
Acute musculoskeletal injury rate
Secondary Outcome Measures
Intervention adherence
Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions
Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference
Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire
Sleep quality
Participants will complete the Pittsburgh Sleep Quality Inventory
Dizziness
Participants will complete the Dizziness Handicap Inventory
Anxiety
Participants will complete the General Anxiety Disorder - 7 scale
Single/dual-task standing and gait
Participants will perform walking trials under single and dual-task conditions
Full Information
NCT ID
NCT05594225
First Posted
October 21, 2022
Last Updated
October 18, 2023
Sponsor
University of Colorado, Denver
Collaborators
Brooke Army Medical Center, Binghamton University
1. Study Identification
Unique Protocol Identification Number
NCT05594225
Brief Title
Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
Official Title
Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Brooke Army Medical Center, Binghamton University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.
Detailed Description
Aim 1. Determine the baseline neuromuscular/dual-task performance characteristics among a sample of active-duty military service members compared to physically active young adult civilians.
The investigators hypothesize that active-duty military service members will have similar baseline gait and dual-task abilities as civilians, demonstrating translation potential between populations.
The investigators also hypothesize that baseline gait and dual-task abilities will be influenced by history of prior mTBI injuries among military Service Members.
Aim 2. Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent mTBI.
The investigators hypothesize that those randomized to the intervention within three weeks of mTBI will have a lower risk of MSK injury in the 3-month period following mTBI, relative to standard-of-care.
The investigators also hypothesize that those randomized to the intervention within three weeks of mTBI will have better post-intervention gait and dual-task performance than those assigned to standard-of-care, despite similar baseline performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants will enroll and undergo initial testing within three weeks of mTBI, be randomized to an 8-week vNDTT or standard-of-care intervention, return for post-intervention testing, and be monitored for subsequent MSK injuries in the three months after mTBI
Masking
Outcomes Assessor
Masking Description
The study PI, Co-Is, and the biostatistician will not know group assignments until after the primary analyses are complete.
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Neuromuscular/Dual-Task Training
Arm Type
Experimental
Arm Description
The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks.
Arm Title
Standard-of-care
Arm Type
No Intervention
Arm Description
Participants will be provided routine instructions related to physical activity and rehabilitation exercises
Intervention Type
Behavioral
Intervention Name(s)
Virtual Neuromuscular/Dual-Task Training
Intervention Description
The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks.
Primary Outcome Measure Information:
Title
Injury rate
Description
Acute musculoskeletal injury rate
Time Frame
3 months after mTBI
Secondary Outcome Measure Information:
Title
Intervention adherence
Description
Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions
Time Frame
Upon enrollment and for the subsequent 8 weeks
Title
Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire
Time Frame
During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Title
Sleep quality
Description
Participants will complete the Pittsburgh Sleep Quality Inventory
Time Frame
During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Title
Dizziness
Description
Participants will complete the Dizziness Handicap Inventory
Time Frame
During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Title
Anxiety
Description
Participants will complete the General Anxiety Disorder - 7 scale
Time Frame
During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Title
Single/dual-task standing and gait
Description
Participants will perform walking trials under single and dual-task conditions
Time Frame
During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-40 years of age at the time of enrollment
Mild TBI or concussion diagnosis by a physician
Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment
Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire [GPAQ]) (Cleland et al., 2014; Keating et al., 2019)
Access to a smartphone for app download
Exclusion Criteria:
Moderate or severe TBI
Pre-injury neurological disorder
Abnormal brain imaging findings (if performed as a part of routine care)
Previous TBI (mild/moderate/severe) <12 months prior to enrollment other than the current injury for which they are being seen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Makenna Hemmerle, MS
Phone
702-777-1502
Email
ConcussionResearch@CUAnschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Kemp, BS
Phone
702-777-1502
Email
ConcussionResearch@CUAnschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Howell, PhD
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David R Howell, PhD
Phone
720-777-1502
Email
ConcussionResearch@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Makenna Hemmerle, MS
Phone
7207771502
Email
ConcussionResearch@cuanschutz.edu
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William T Davis, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Unidentified/blinded IPD data may be made available upon reasonable request.
Learn more about this trial
Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
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