Tele-Rehabilitation for Concussion

Not currently recruiting at 1 trial location

Overseen By Lindsey Kemp, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Disqualifiers: Moderate/severe TBI, Neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual rehabilitation method for individuals who recently experienced a concussion. It evaluates the effectiveness of a smartphone-based exercise program, Virtual Neuromuscular/Dual-Task Training (vNDT), in aiding the recovery of physical abilities through strength and stabilization exercises over eight weeks. The trial seeks healthy military service members and active young adults who have had a mild concussion and regularly exercised before their injury. Participants must have access to a smartphone to use the program. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to experience this innovative approach firsthand.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Virtual Neuromuscular/Dual-Task Training is safe for use in concussion rehabilitation?

Research has shown that Virtual Neuromuscular/Dual-Task Training (vNDTT) for concussions is generally well-tolerated. Early results from other studies suggest that the exercises, which focus on strengthening the lower body and improving balance, have manageable side effects for people with brain injuries like concussions. Although specific side effects are not detailed, this being a Phase 1 trial means it is an early stage of testing that focuses on safety. This indicates that the treatment has not been widely tested in humans yet, so there may be unknown risks. However, tele-rehabilitation for similar conditions has been considered safe so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Neuromuscular/Dual-Task Training (vNDTT) for concussion rehabilitation because it combines strength exercises with a focus on landing stabilization, delivered virtually. Unlike standard care, which typically involves routine physical activity instructions, vNDTT offers a structured, interactive approach that can be accessed remotely. This innovative method not only enhances convenience and accessibility for participants but also targets both physical and cognitive recovery, potentially leading to more comprehensive rehabilitation outcomes.

What evidence suggests that Virtual Neuromuscular/Dual-Task Training is effective for concussion recovery?

Research has shown that virtual Neuromuscular/Dual-Task Training (vNDTT), which participants in this trial may receive, can aid recovery after a concussion. One study found that this training improves balance and cognitive skills. It combines exercises that enhance strength and stability with activities that challenge the brain. Another review found that dual-task training can boost movement and cognitive abilities in individuals with brain-related issues. This suggests it could effectively support recovery from concussions by aiding both physical and mental healing. ^{1 2 5 6 7}

Who Is on the Research Team?

David R Howell, PhD

Principal Investigator

University of Colorado School of Medicine

Are You a Good Fit for This Trial?

This trial is for U.S. military members and active young adults aged 18-40 who've had a mild traumatic brain injury (TBI) or concussion recently, diagnosed by a physician. They must have been physically active before the injury and own a smartphone to download an app.

Inclusion Criteria

I have been diagnosed with a mild traumatic brain injury or concussion.

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)

Exclusion Criteria

Pre-injury neurological disorder

Abnormal brain imaging findings (if performed as a part of routine care)

I have had a moderate or severe traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the virtual Neuromuscular/Dual-Task Training (vNDTT) intervention for 8 weeks

8 weeks

Initial visit (virtual), ongoing virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of musculoskeletal injury rate and quality of life

3 months

Follow-up evaluation (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Neuromuscular/Dual-Task Training

Trial Overview

The study tests if using your smartphone for virtual Neuromuscular/Dual-Task training can help with recovery from mild TBI or concussion. It checks how practical and effective this remote rehab method is compared to usual care.

How Is the Trial Designed?

Group I: Virtual Neuromuscular/Dual-Task Training Experimental Treatment 1 Intervention

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.

Group II: Standard-of-care Active Control 1 Intervention

Participants will be provided routine instructions related to physical activity and rehabilitation exercises

Virtual Neuromuscular/Dual-Task Training is already approved in United States for the following indications:

Approved in United States as Virtual Neuromuscular/Dual-Task Training for:

• Mild Traumatic Brain Injury recovery
• Reducing subsequent injury risk

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Binghamton University

Collaborator

Trials

15

Recruited

2,900+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Published Research Related to This Trial

Both mobile application-based telerehabilitation (TR) and virtual reality-supported task-oriented circuit therapy (V-TOCT) significantly improved upper limb function, trunk impairment, and ataxia severity in patients with Multiple Sclerosis (PwMS) after 8 weeks of treatment involving 34 participants.

V-TOCT was found to be more effective than TR in enhancing dynamic trunk control and kinetic function, as evidenced by improved kinematic metrics and functional range of motion in the shoulder and trunk joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation versus virtual reality supported task-oriented circuit therapy on upper limbs and trunk functions in patients with multiple sclerosis: A randomized controlled study. Doğan, M., Ayvat, E., Kılınç, M.[2023]

A case study of a 41-year-old service member showed that traditional physical therapy alone was insufficient for recovery after head trauma, but incorporating a Computer Assisted Rehabilitation Environment significantly improved his vestibular function and walking speed.

After 6 weeks of this advanced therapy, the patient regained enough confidence and ability to return to full active duty, suggesting that virtual reality-based rehabilitation can be a safe and effective option for those needing to meet high performance standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in dizziness and imbalance results from using a multi disciplinary and multi sensory approach to Vestibular Physical Therapy - a case study. Gottshall, KR., Sessoms, PH.[2020]

The pilot study involving seven adults with chronic stroke demonstrated that a home-based telerehabilitation program significantly improved upper limb performance over 6 weeks of training, with participants training 5 days a week for 60 minutes each session.

In addition to physical improvements, there were indications of potential cognitive benefits, suggesting that telerehabilitation may enhance overall recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. Langan, J., Delave, K., Phillips, L., et al.[2021]

Teleassessment and telerehabilitation for individuals with traumatic brain injury (TBI) are gaining interest, but there is currently a lack of formal research and large-scale clinical trials to support their effectiveness.

Before telerehabilitation can be widely adopted and reimbursed, several critical areas need to be addressed, highlighting the need for more evidence-based applications in TBI care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and methodological considerations in the application of telerehabilitation after traumatic brain injury: a commentary. Ricker, JH.[2015]

A retrospective study involving 82 clients with Acquired Brain Injury (ABI) showed that a Kinect-based tele-rehabilitation program significantly improved upper extremity function and cognitive abilities after 2 months of biweekly sessions.

Participants reported high satisfaction with the tele-rehabilitation service, indicating that it is a feasible and beneficial option for improving motor and cognitive skills in individuals with ABI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-rehabilitation service delivery journey from prototype to robust in-home use. Kizony, R., Weiss, PL., Harel, S., et al.[2022]

Telerehabilitation for subacute mild traumatic brain injury (mTBI) was found to be feasible, with similar withdrawal rates and high session attendance compared to in-person rehabilitation, indicating it can be a viable alternative during situations like the COVID-19 pandemic.

Both in-person and telerehabilitation interventions led to significant symptom reductions, with the in-person group showing a larger effect size (-0.94) compared to the telerehabilitation group (-0.73), suggesting that the telerehabilitation program may need further adaptation to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Adoption of Telerehabilitation for Treating Mild Traumatic Brain Injury. Campbell, KR., Wilhelm, JL., Pettigrew, NC., et al.[2023]

Structured telephone-based interventions for adults with traumatic brain injury (TBI) showed positive effects on global functioning, posttraumatic symptoms, sleep quality, and depressive symptoms, with 4 out of 5 randomized controlled trials reporting significant improvements.

While the feasibility of Internet-based telerehabilitation was supported, the evidence for its efficacy remains inconclusive due to a lack of sufficient studies, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Telerehabilitation for Adults With Traumatic Brain Injury: A Systematic Review. Ownsworth, T., Arnautovska, U., Beadle, E., et al.[2019]

The Tele-Active Rehabilitation (Tele-AR) program, delivered remotely over 6 weeks to three adolescents with concussion, showed high adherence (77%-100%) and no adverse events, indicating it is a safe and feasible option for rehabilitation.

All participants reported improvements in postconcussion symptoms, illness perception, and occupational performance, suggesting that Tele-AR may effectively support recovery in adolescents with concussion, warranting further research into its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Active Rehabilitation for adolescents with concussion: a feasibility study. Shore, J., Hutchison, MG., Nalder, E., et al.[2022]

Tele-neurorehabilitation (TNR) applications have shown promise in effectively managing various neurological conditions, with 13 out of 19 studies demonstrating outcomes at least equivalent to traditional rehabilitation methods.

The review included 19 studies across 13 conditions, with 16 studies rated as high or good quality, indicating that while TNR is effective, further research is needed to establish routine use for some applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The status of telerehabilitation in neurological applications. Hailey, D., Roine, R., Ohinmaa, A., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05594225?term=AREA%5BConditionSearch%5D(%22Brain%20Concussion%22)&rank=9

Tele-Rehabilitation to Improve Mild Traumatic Brain Injury ...

Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent ...

2.

withpower.com

withpower.com/trial/phase-1-brain-injuries-2023-99949

Tele-Rehabilitation for Concussion · Info for Participants

Trial Overview The study tests if using your smartphone for virtual Neuromuscular/Dual-Task training can help with recovery from mild TBI or concussion. It ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4470324/

Motor-Cognitive Dual-Task Training in Neurologic Disorders

This review was conducted to determine the effectiveness of motor-cognitive dual-task training (DTT) compared to usual care on mobility and cognition in ...

4.

peearz.com

peearz.com/trialsindex?nctid=NCT05594225

Tele-Rehabilitation to Improve Mild Traumatic Brain Injury ...

The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered ...

5.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1558795/full

A virtual reality system for delivery of military-specific ...

A preliminary study to identify locomotor-cognitive dual tasks that reveal persistent executive dysfunction after mild traumatic brain injury.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02920788

Study Details | NCT02920788 | Mild TBI Assessment & ...

The primary objectives of this study are to investigate the potential short and longer term effects of GOALS cognitive training program, and to use advanced MRI ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12320714/

What are the evidence-based medical management ...

Concussions or mild traumatic brain injuries (mTBI) are common within the youth athletic and sporting populations (3). The term concussion is ...