Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training

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

The purpose of this research study is to test the effectiveness of virtual reality (VR) based treadmill training on walking ability. The study will also help to understand the changes in cognitive ability and brain activity as a result of VR-based treadmill training after a brain injury.

The study will include 3 groups: C-MILL training group (CTG), Treadmill training group (TTG), and healthy control group (HCG).

Individuals with brain injury will be randomly assigned to C-MILL training group, or Treadmill training group.

The CTG and TTG will participate in up to 13 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, 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.

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-MILLsession.

Each training session will last for 45 minutes. During the 45 minutes, the participants will perform the task for approximately 1 minute. Participants will be allowed as much rest as needed by them.

During the training all participants will wear the safety harness to protect from falling. In addition spotter will be present with the participants to prevent falls.

Data Collection:

Each participant's baseline and follow up data will be collected for a) functional b) neuromechanical c) cortical and d) cognitive outcomes. During walking on treadmill data will also be collected with instrumented C- MILL. C-MILL can provide gait parameters such as step length, width, frequency, speed and symmetry in addition to center of pressure for evaluation of gait and balance.

During Training Sessions: The instrumented treadmill will collect force data during training.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Virtual reality treadmill training; Other: Treadmill Training

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiran Karunakaran, PhD; Phone Number: 973-324-3590; Email: kkarunakaran@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Kiran Karunakaran, PhD; Phone Number: 973-324-3590
      • Principal Investigator: Kiran Karunakaran, PhD
      • Sub-Investigator: Karen Nolan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-MILL training group; 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.	Device: Virtual reality treadmill 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.; Other Names: C-MILL training, C-Mill (Motek, the Netherlands)
Active Comparator: Treadmill training group (TTG); 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.	Other: Treadmill Training; Conventional gait and balance training using treadmill.
No Intervention: Healthy Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dynamic Gait Index (DGI)	DGI is a measurement tool commonly used to assess dynamic balance, gait and risk for falls. It consist of a total of eight gait assessments which can be scored on a four-point ordinal scale, ranging from 0-3, where '0' indicates the lowest level of function and '3' the highest level of function, allowing for a total possible score of 24.	5 weeks
Change in Timed Up and Go (TUG)	TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.	5 weeks
Change in Six Minute Walk	Participants walk as far as possible for 6 minutes. They walk back and forth around the cones along an unobstructed pathway of 15 meters. They will be permitted to slow down or stop as necessary. The distance covered by the participant for the 6 minutes will be recorded at an interval of every 30 seconds using a measuring wheel and stop watch.	5 weeks
Change in Ten Meter Walk Test	This is a walking test. I will be asked to walk as fast as I can at a safe speed for 10 meters (about 10 yards).	5 weeks
Change in Temporal Characteristics using pressure mat	Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect gait cycle times, in order to determine inter- and intra-limb temporal characteristics.	5 weeks
Change in Spatial Characteristics	Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect spatial parameters, in order to determine inter- and intra-limb spatial characteristics.	5 weeks
Change in Silver Index	Silver index using Movendo Technology platform (Movendo Technology Srl,, Italy) is an objective test that enables to predict falls by assessing static and dynamic balance. Participants will be asked to stand on the Hunova platform. Silver index includes the following tasks: stand with eyes open or eyes closed, stand when the surface is perturbed, move torso on all four sides, perform sit to stand.	5 weeks
Change in Cortical Activity	Cortical activity will be measured using 16 channel NIRSport 2 (NIRX Medical Technologies, LLC ), an Functional Near Infrared Spectroscopy (fNIRS) system. NIRSport 2 is a portable, non-invasive optical imaging technique to measure the cerebral hemodynamic response. fNIRS will be measure while the participants walks at a comfortable speed.	5 weeks
Change in Trail Making Test A and B	The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper. Trail making Test A and B assess processing speed and executive function.	5 weeks
Change in Montreal Cognitive Assessment Test	30-item question to assess cognitive impairment. MoCA is used to test orientation, attention, memory, and executive function.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Kinematics	Natural Point's optitrack camera system will be used to collect joint angles at hip, knee and ankle using reflective markers placed on the anatomical joints.	5 weeks
Change in Electromyography	Noraxon's surface Electromyography (EMG) wireless sensors will be used to measure the activation of tibialis anterior, soleus, vastus lateralis, rectus femoris, bicep femoris, and gastrocnemius during walking.	5 weeks
Change in Continuous Performance Task (CPT)	The test requires a subject to click only when presented with a target. They must refrain from clicking if they see anything other than the target. To increase the difficulty, they will be asked to click if they see another stimuli before the target. CPT assesses sustained and selective attention.	5 weeks
Change in C-MILL Force Data	Force data during walking and standing will be collected during training sessions by the C-MILL	10 training sessions

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): September 29, 2024
• Study Completion (Estimated): September 29, 2024

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R-1125-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No