Improving walking ability in individuals with traumatic brain injury using virtual reality treadmill training

Pilot Study to Improve Ambulation in Individuals With Traumatic Brain Injury (TBI) Using Virtual Reality -Based Treadmill Training

This study is testing if virtual reality treadmill training can help people with traumatic brain injuries walk better compared to traditional treadmill training.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 13 Years to 35 Years
• Sex: All
• Sponsor: Kessler Foundation (other)
• Locations: 1 site (West Orange, New Jersey)
• Trial ID: NCT05130658 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of virtual reality-based treadmill training on improving walking ability in individuals who have suffered a traumatic brain injury (TBI). Participants will be divided into three groups: one receiving virtual reality training, another undergoing traditional treadmill training, and a healthy control group. The study will involve up to 13 sessions, including pre- and post-training assessments to measure changes in walking ability, cognitive function, and brain activity. The goal is to determine how VR training can enhance rehabilitation outcomes for TBI survivors.

Who should consider this trial

Good fit: Ideal candidates are TBI survivors aged 13-35 who are more than 6 months post-injury and can tolerate standing for up to 30 minutes.

Not a fit: Patients with severe cognitive deficits, significant joint issues, or those who weigh over 300 lbs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve ambulation and overall rehabilitation outcomes for individuals recovering from traumatic brain injuries.

How similar studies have performed: While the use of virtual reality in rehabilitation is gaining traction, this specific approach to treadmill training for TBI is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion/exclusion criteria for TBI:

Inclusion Criteria:

Participants must:

* Be TBI survivors \> 6 months post TBI
* Be able to tolerate upright standing for up to 30 minutes.
* Have joint range of motion within normal functional limits for walking as determined by study staff.
* Be between 13-35 years of age.
* Be able to follow directions and commands.
* Be able to communicate in English.
* Have stable blood pressure.
* Not been diagnosed with any cognitive (thinking) deficits.

Exclusion Criteria:

* Weight above 300lbs.
* Joint contracture or spasticity of any limb that limits normal range of motion during ambulation with assistive devices.
* Have any medical issue that prevents from supporting his/her weight (e.g. orthopedic injuries, pain, or severe spasticity).
* Have pre-existing condition that causes exercise intolerance (e.g. documented uncontrolled hypertension, coronary artery disease, irregular heart rate or rhythm, or congestive heart failure).
* Skin issues that would prevent from wearing a harness.
* Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
* Have uncontrolled seizure disorder.
* Have uncontrolled spasticity that would interfere with walking.
* Diagnosed with cognitive (thinking) problems prior to TBI.
* Have neuromuscular or neurological issues (e.g. spinal cord injury, multiple sclerosis, or Parkinson's disease)

Inclusion/exclusion criteria for Healthy controls:

Inclusion Criteria:

Participants must:

* Be able to tolerate upright standing for up to 30 minutes.
* Have joint range of motion within normal functional limits for ambulation.
* No history of orthopedic, neuromuscular, cognitive or neurological disorders.
* Be between 13-35 years of age.
* Have stable blood pressure; no diagnosis of persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in body weight support system).
* No diagnosed cognitive deficits.

Exclusion Criteria:

* Weight above 300lbs
* Joint contracture or spasticity of any limb that limits normal range of motion during ambulation with assistive devices.
* Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
* Pressure sore that would negatively affect weight bearing, or harness fit.
* Pre-existing condition that causes exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
* Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
* Uncontrolled seizure disorder.
* Uncontrolled spasticity that would interfere with walking due to neuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis) that will interfere with ambulation, or limit the range of motion of the lower limbs
* Diagnosed with cognitive deficits.

Where this trial is running

West Orange, New Jersey

• Kessler Foundation — West Orange, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Kiran Karunakaran, Phd

Conditions: Traumatic Brain Injury