TPAD for Recovery of Standing After Severe SCI
ConditionSCI - Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKessler Foundation
About this trial
The purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD.
The main aims are to:
1\. Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance
2 and 3. Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals.
Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury:
Group 1:
* Individuals with SCI that can stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about six months
Group 2:
* Individuals with SCI that cannot stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about 6 months
Group 3:
* Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks
Group 4:
* Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks
Group 5:
* Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 18 years of age at the time of enrollment;
stable medical condition
at least one year post-spinal cord injury (Groups 1-4)
non-progressive, traumatic SCI above T10 (Groups 1-4)
Disqualifiers
unwillingness to wean from anti-spasticity medications;
untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
ongoing drug abuse
Trial design
Design model
Parallel
Treatments tested in this trial
The Tethered Pelvic Assist Device (TPAD)
Devicea light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
Treatment groups
50 Participants
are divided into 5 treatment groupsGroup A: Group 1Other 1 intervention
Group B: Group 2Other 1 intervention
Group C: Group 3No intervention 0 interventions
Group D: Group 4No intervention 0 interventions
Group E: Group 5No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sitting Assessment
Research participants will sit on a padded table and perform tasks to challenge their balance control (reaching/shifting weight in multiple directions). Assistance for sitting will be provided at the trunk by the TPAD or by the trainer. EMG and kinematic analysis will be performed on the lower extremities, trunk and upper extremities during sitting. The trunk force and position controller data from the TPAD will be also collected; these data will be synchronized with EMG and kinematic data. Muscle activation patterns will be evaluated recording EMG from different muscle groups. The TPAD/trainer will then generate controlled loss of balance during sitting. EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance will be compared. EMG mean and integrated amplitudes from each muscle will be compared before and after training. Relationships between these parameters will also be calculated and compared with non-disabled data.
Time frame
On average 4 hours to complete. Done at the beginning of the study for groups 1, 2, and 5. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).2
Neuromuscular Recovery Scale (NRS)
Research participants will undergo a series of tasks to test the level of muscle activation and amount of assistance required during standing and stepping in a body-weight supported treadmill environment, as well as overground motor tasks. Arm, trunk/leg movement recovery and independency will be measured by the NRS using 14 motor tasks (sit, reverse sit up, sit up, sitting truck extension, overhead press, forward reach and grasp, door pull and open, can open and manipulation, sit to stand, stand, walking, stand adaptability, step retraining, and step adaptability) and combined with EMG, kinematic, and kinetic analyses on the upper and lower extremities and/or trunk. Based on the performance across categories, 4 phase scores can be assigned:1- greatest impairment relative to normal movement patterns (non-ambulatory), 2- begins to stand and weight support independently, 3- walking with varying skill levels, and 4- normal locomotor and transfer performance with adaptability.
Time frame
On average, 2 hours to complete. Groups 1 and 2 will complete the NRS at the beginning of the study and at the end (on average 6 months).3
Standing Assessment
Participants will stand as long as possible and undergo a series of standing tasks. Electromyography (EMG), kinematic and kinetic analysis will be performed on the lower extremities and trunk during standing. The pelvic, trunk and knee force and position controller data from the TPAD will be collected and synchronized. Muscle activation patterns will be evaluated recording EMG from different muscle groupings. When appropriate, ground reaction forces will be measured. Blood pressure and heart rate will be measured. The TPAD will then generate controlled loss of balance during standing. Participants will regain balance with/without grasping a fixed object. Investigators will compare EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance if applicable. EMG mean and amplitudes from each muscle will be compared before and after training. The relationship between these parameters will also be calculated and compared with non-disabled data.
Time frame
On average 4 hours to complete. Done at the beginning of the study for all groups. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).Sponsors and contacts
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Source ClinicalTrials.gov