Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury

Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain

The purpose of this study is to assess a balance training program to see if it can be helpful to improve balance and avoid falls in people who have had traumatic brain injuries (TBIs).

The study will involve three groups of research subjects: 1) TBI-intervention group, 2) TBI- non-intervention group and 3) the participants without disability group.

The TBI intervention Group will participate in 10 robotic balance training sessions. Data will collected pre and post-training.

TBI- non-intervention group will not receive any training. They will participate in two data collection sessions which are about 5 weeks apart.

The participants without disability group will not receive any training. They will participate in one data collection session.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: TBI - Intervention Group

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

Contacts and Locations

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

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Participants with TBI:

Inclusion Criteria:

• Be between the ages of 18 and 65.
• Have been diagnosed with a TBI by a physician and be at least 6 months post injury and not more than 5 years post injury.
• Have been medically stable for 3 months prior to the most recent TBI.
• Not plan to make any drastic changes to medications (as determined by study staff) for at least 4 weeks.
• Be able to stand unsupported for 5 minutes.
• Be willing and able to give informed consent.
• Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.

Exclusion Criteria:

• Weight above 300 lbs.
• Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure.
• Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing.
• Have additional medical conditions that affect the bones, muscles or nerves that would interfere with the balance.
• Have any previously diagnosed history of balance problems prior to TBI.
• Have fluctuating blood pressure.
• Be on any medication that may affect balance, strength, or muscle coordination (e.g. Botox).
• Be currently enrolled in another research study that is likely to affect participation in this research study.
• Have seizure disorder.

Participants without a disability:

Inclusion Criteria:

• Be between the ages of 18 and 65.
• Not plan to make any drastic changes to medications for at least 4 weeks.
• Not have an orthopedic, cognitive or neuromuscular disease.
• Be able to stand unsupported for 5 minutes.
• Be willing and able to give informed consent.
• Be able and willing to comply with study procedures, including follow-up requirements.

Exclusion Criteria:

• Weight above 300 lbs.
• Have a history of injury to my lower limbs in the past 90 days.
• Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure.
• Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing.
• Have any additional medical conditions that affect my bones, muscles, or nerves that would interfere with the movement or the ability to feel touch or pain.
• Have difficulty following or responding to commands that would limit the study participation.
• Be currently enrolled in another research study that is likely to affect participation in this research study.

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: TBI - Intervention Group; The participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times.	Device: TBI - Intervention Group; The participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times.
No Intervention: TBI - Non Intervention Group; Participants will receive no intervention
No Intervention: Participants without disability group; Participants will receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Assessment	A task performance test consisting of 14 items of increasing difficulty graded on a five-point ordinal scale of 0 to 4 (0 = subject is unable to perform task; 4 = subject is independent in performance of task) giving the best possible score of 56 for healthy balance.	5 weeks
Dynamic Gait Index	Dynamic Gait Index (DGI) is a measurement tool commonly used to assess dynamic balance, gait and risk for falls. It consists 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
Timed Up and Go	It 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 stopwatch.	5 weeks
10 Meter walk test	Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.	5 weeks
Fall Efficacy Scale -International	This questionnaire is a widely accepted tool for the assessment of fear of falling and has excellent reliability and validity. It is a self-reported questionnaire that provides information on the level of concern about falls for a range of daily living activities. The original questionnaire contains 16 items and is scored on a four-point scale (1 = not very concerned to 4 = very concerned). Therefore the best possible value is 16 and the worst is 64.	5 weeks
Community Balance and Mobility Scale	Used to detect 'high level' balance and mobility deficits based on tasks commonly encountered in community environments. Composed of 13 challenging tasks (scaled from 0 = complete inability to perform task to 5 = most successful completion of item available).	5 weeks
Temporal- 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 gait cycle times and step length, in order to determine inter- and intra-limb temporal and spatial characteristics.	5 weeks
Electromyography	surface Electromyography (EMG) wireless sensors will be used to measure the activation of tibialis anterior, soleus, vastus lateralis, rectus femoris, bicep femoris, and gastrocnemius.	5 weeks
Cortical activity	Cortical activity will be measured using 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.	5 weeks
Balance	Quantitative measures of static and dynamic balance will be assessed using the Hunova balance platform.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
community ambulation	Sensors will be provided to be worn in wrist, leg and waist to collect gait cycle times and step length during community ambulation of the participants between baseline and follow-up. The participants will also wear the sensor during testing walking and balancing tasks at baseline and follow-up.	5 weeks

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Kiran Karunakaran, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 28, 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-1229-2

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