Spinal Cord Injury Clinical Trial
Official title:
Biomechanical Validation of the Transfer Assessment Instrument (TAI)
The purpose of this research study is to further develop and refine the Transfer Assessment Instrument (TAI). The TAI is a clinical tool to be used by therapists to evaluate transfer techniques and performance.
For Veterans who rely on wheelchairs for mobility, performing transfers is essential to
achieving independence with activities of daily living. For example, transfers are required
for getting into and out of bed, on and off a bath tub/shower seat, commode seat, motor
vehicle seat and so on. Unfortunately transfers, along with wheelchair propulsion, weight
relief and overhead activities are believed to largely contribute to the development of
shoulder pain and injury. For individuals who rely are their arms for independence with ADL,
the onset of pain or an overuse injury can be devastating leading to increased healthcare
expenses, limitation in activity, depression, decreased societal participation and a reduced
quality of life. Despite the importance of transfers to daily living and that transfers rank
among the most strenuous wheelchair-related activities, there is a paucity of research on
the biomechanics of transfers.
During rehabilitation, achieving transfers in the safest and most efficient manner possible
has traditionally been the goal of both the patient and clinician. However, there is wide
variation in the amount and quality of transfer training that is provided in rehab. The
ergonomics of performing transfers is crucial to maintaining maximal upper limb function and
pain free limbs over time. The techniques taught to patients during rehab are not based on
scientific evidence and there is not a uniform way of measuring performance. For these
reasons, the investigators developed the Transfer Assessment Instrument (TAI) a 29-item
criterion-referenced construct comprised of three domains 1) preparing for a transfer, 2)
use of conservation techniques, and 3) quality of the transfer. The instrument was designed
to be used by therapists in the clinic to determine a patient's adherence with 'best'
transfer techniques, identify targeted areas of intervention, and document performance
outcomes pre-post transfer training, intervention (e.g. trunk orthosis) or change in medical
status. The TAI includes items that address the ergonomics of transferring independently and
dependently for patients who need assistance either from a caregiver or with transfer
equipment.
The intent of the proposed three-year study is to establish the psychometric rigor of the
TAI with wheelchair users with SCI using a two-phase approach. In Phase 1, 100 subjects will
be evaluated for initial psychometric analysis and tool refinement. In Phase 2, using the
refined tool extensive biomechanical validation studies will be conducted with 70
individuals who independently perform wheelchair transfers. Tool validation is an important
first step towards the effective translation of evidence-based practices into a clinical
setting. As a result, the proposed work has great potential to improve the quality of care
of veteran patients and reduce the incidence of upper limb pain and injuries.
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Recruiting |
NCT05941819 -
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|
||
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 |