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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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 d

Первичные конечные точки

• Berg Balance Assessment [Срок оценки: 5 weeks]
• Dynamic Gait Index [Срок оценки: 5 weeks]
• Timed Up and Go [Срок оценки: 5 weeks]
• 10 Meter walk test [Срок оценки: 5 weeks]
• Fall Efficacy Scale -International [Срок оценки: 5 weeks]
• Community Balance and Mobility Scale [Срок оценки: 5 weeks]
• Temporal- spatial characteristics [Срок оценки: 5 weeks]
• Electromyography [Срок оценки: 5 weeks]
• Cortical activity [Срок оценки: 5 weeks]
• Balance [Срок оценки: 5 weeks]

Вторичные конечные точки (1)

• community ambulation [Срок оценки: 5 weeks]

Критерии участия

Participants with TBI:

Критерии включения

• 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.

Критерии исключения

• 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:

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT06184295 · R-1229-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗