Clinical trial NCT06184295: Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury
Official title: Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Participants with TBI:

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.

Primary outcomes:
measure: Berg Balance Assessment
timeFrame: 5 weeks
measure: Dynamic Gait Index
timeFrame: 5 weeks
measure: Timed Up and Go
timeFrame: 5 weeks
measure: 10 Meter walk test
timeFrame: 5 weeks
measure: Fall Efficacy Scale -International
timeFrame: 5 weeks
measure: Community Balance and Mobility Scale
timeFrame: 5 weeks
measure: Temporal- spatial characteristics
timeFrame: 5 weeks
measure: Electromyography
timeFrame: 5 weeks
measure: Cortical activity
timeFrame: 5 weeks
measure: Balance
timeFrame: 5 weeks
Secondary outcomes:
measure: community ambulation
timeFrame: 5 weeks
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Kiran Karunakaran
role: PRINCIPAL_INVESTIGATOR
References: