NCT06184295 · Kessler Foundation
Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- West Orange, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2024 · Source of record for eligibility and locations