An interventional study of TBI - Intervention Group in Traumatic Brain Injury, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 30 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with TBI:
Inclusion Criteria:
Exclusion Criteria:
Participants without a disability:
Inclusion Criteria:
Exclusion Criteria:
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
Participants will receive no intervention
Participants will receive no intervention
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 weeks
Balance
Quantitative measures of static and dynamic balance will be assessed using the Hunova balance platform.
Time frame: 5 weeks
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.
Time frame: 5 weeks
Plan to share: Undecided
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