Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
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.
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
C-MILL training group
Treadmill training group (TTG)
Healthy Control
The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in the CTG will receive gait and balance training sessions with the virtual reality and auditory cues using C-MILL (such as walking on a pathway, obstacle avoidance, lateral balance etc.) to provide task specific training. C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment.
The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in TTG group will walk on the treadmill (C-MILL) or stand on the treadmill (C-MILL) with no visual or auditory cues.
HCG will participate in up to four sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions and one C-MILL session.