Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury
NCT ID: NCT06184295
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-01-01
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
TBI - Non Intervention Group
Participants will receive no intervention
No interventions assigned to this group
Participants without disability group
Participants will receive no intervention
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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:
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Kessler Foundation
OTHER
Responsible Party
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Kiran Karunakaran
Research Scientist
Principal Investigators
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Kiran Karunakaran
Role: PRINCIPAL_INVESTIGATOR
Kessler Foundation
Locations
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Kessler Foundation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Kiran Karunakaran, PhD
Role: primary
Other Identifiers
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R-1229-23
Identifier Type: -
Identifier Source: org_study_id