Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Kessler Foundation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Electromyography
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Kiran Karunakaran
Research Scientist
Kessler Foundation
Eligibility Criteria
Inclusion Criteria
- •Be between the ages of 18 and
- •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:
Outcomes
Primary Outcomes
Electromyography
Time Frame: 5 weeks
surface Electromyography (EMG) wireless sensors will be used to measure the activation of tibialis anterior, soleus, vastus lateralis, rectus femoris, bicep femoris, and gastrocnemius.
Dynamic Gait Index
Time Frame: 5 weeks
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.
10 Meter walk test
Time Frame: 5 weeks
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Fall Efficacy Scale -International
Time Frame: 5 weeks
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.
Community Balance and Mobility Scale
Time Frame: 5 weeks
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).
Temporal- spatial characteristics
Time Frame: 5 weeks
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.
Cortical activity
Time Frame: 5 weeks
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.
Timed Up and Go
Time Frame: 5 weeks
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.
Berg Balance Assessment
Time Frame: 5 weeks
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.
Balance
Time Frame: 5 weeks
Quantitative measures of static and dynamic balance will be assessed using the Hunova balance platform.
Secondary Outcomes
- community ambulation(5 weeks)