Clinical trial NCT01183546: Biomechanical Validation of the Transfer Assessment Instrument (TAI)
Official title: Biomechanical Validation of the Transfer Assessment Instrument (TAI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: rehabilitation
spinal cord injury
wheelchairs
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-08-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To initially evaluate the transfer measurement system and protocol, individuals without disability will be recruited (preliminary phase). After validating and evaluating the reliability and sensitivity of the measurement system, individuals with paraplegia and tetraplegia will be recruited (final phase).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

For preliminary phase (control subjects)

1. 18 years old or over
2. Ability to do a seated push up (from a seated position, elevate torso and lift buttocks off of the seat using the upper limbs)

For final phase (case subjects)

1. 18 years old or over
2. C4 level or below spinal cord injury
3. Ability to perform an independent transfer (without assistive device or human assistance)
4. Manual wheelchair user For preliminary phase (control subjects)

(1) No significant upper extremity pain or injury that would inhibit the ability to perform transfers or weight bear on the upper extremities.

Exclusion Criteria:

For final phase (case subjects)

1. No significant upper extremity pain or injury that would inhibit the ability to perform transfers or weight bear on the upper extremities.
2. A history of cardiopulmonary (heart/lung condition) that may be exacerbated.
3. Active pressure sores, or a history of pressures sores that may be exacerbated.
4. Functional motor control in the lower extremities.

Primary outcomes:
measure: Transfer Performance (TAI Scores Part 1)
timeFrame: Baseline Testing and at Followup Testing (4 weeks)
Secondary outcomes:
measure: Shoulder Peak Resultant Moment
timeFrame: Baseline Testing and at Followup Testing (4 weeks)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health Care System
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Health Care System
name: Alicia M Koontz, PhD
role: PRINCIPAL_INVESTIGATOR
References: