Tele-Rehabilitation for Concussion

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

88 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Virtual Neuromuscular/Dual-Task Training for concussion?

Research shows that telerehabilitation, which includes virtual environments and multitasking, can help improve recovery in people with brain injuries. For example, a study found that a virtual rehabilitation program helped a person with head trauma improve balance and confidence, allowing them to return to full duty. This suggests that similar virtual treatments could be effective for concussions. ^{1 2 3 4 5}

Is tele-rehabilitation generally safe for humans?

The available research suggests that tele-rehabilitation, including for conditions like traumatic brain injury and multiple sclerosis, is generally safe and can provide outcomes similar to traditional in-person rehabilitation. However, more large-scale studies are needed to fully establish its safety and effectiveness for routine use. ^{2 5 6 7 8}

How is the treatment Virtual Neuromuscular/Dual-Task Training for concussion different from other treatments?

Virtual Neuromuscular/Dual-Task Training is unique because it uses a virtual environment to combine physical and cognitive exercises, allowing patients to practice tasks that challenge both their body and mind. This approach can be more accessible as it is delivered remotely, making it easier for patients to receive therapy without needing to travel to a clinic. ^{1 2 5 7 9}

Research Team

David R Howell, PhD

Principal Investigator

University of Colorado School of Medicine

Eligibility Criteria

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.

I am between 18 and 40 years old.

Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

1. Switzerland 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Telerehabilitation for Adults With Traumatic Brain Injury: A Systematic Review. [2019]

3. Sweden pubmed.ncbi.nlm.nih.gov

Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation and Adoption of Telerehabilitation for Treating Mild Traumatic Brain Injury. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Tele-Active Rehabilitation for adolescents with concussion: a feasibility study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The status of telerehabilitation in neurological applications. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. Netherlands 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Tele-rehabilitation service delivery journey from prototype to robust in-home use. [2022]