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

NCT06184295 | Recruiting FDA Device

• 1 other identifier: R-1229-23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• community ambulation

  5 weeks

Study Arms (3)

TBI - Intervention Group

EXPERIMENTAL

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

TBI - Non Intervention Group

NO INTERVENTION

Participants will receive no intervention

Participants without disability group

NO INTERVENTION

Participants will receive no intervention

Interventions

TBI - Intervention Group DEVICE

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.

TBI - Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kiran Karunakaran

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiran Karunakaran, Ph.D.

CONTACT

973-324-3590; kkarunakaran@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (1)