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Biomechanical Validation of the Transfer Assessment Instrument (TAI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01183546
First received: July 16, 2010
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomechanical Validation of the Transfer Assessment Instrument (TAI)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Transfer performance (TAI scores, biomechanical variables) [ Time Frame: Phase I: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Upper limb pain (questionnaires) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Upper Limb Function and Balance Assessment [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Transfer performance (TAI scores, biomechanical variables) [ Time Frame: Phase I: within 4-72 hours of baseline assessment (first 25 subjects) ] [ Designated as safety issue: No ]
  • Transfer performance (TAI scores, biomechanical variables) [ Time Frame: Phase II: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
wheelchair users with ASIA A or B spinal cord injury

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, we 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited through IRB approved registries developed by the VA Rehab R&D Center Human Engineering Research Laboratories (VA IRB #01185) and the Department of Physical Medicine and Rehabilitation (IRB #0304069). Potential subjects may also be recruited through the VA Polytrauma, Spinal Cord Injury, and Rehab Seating and Power Wheelchair Clinics, Center for Assistive Technology (CAT) and the UPMC Medical Center.

Criteria

Inclusion Criteria:

Phase 1: Inclusion Criteria

  • ASIA A or B spinal cord injury
  • at least one year post-injury and medically stable
  • able to sit upright for at least 4 hours a day
  • over the age of 18 years
  • use a wheelchair for mobility

Phase 2: Inclusion Criteria same as for Phase 1 with the addition of the following:

  • able to independently transfer to/from a wheelchair without human assistance or assistive devices

Exclusion Criteria:

Exclusion Criteria (Both Phase 1 and 2)

  • current or recent history of pressure sores
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183546

Contacts
Contact: Annmarie R Kelleher, MS OTR (412) 954-5287 ext 5279 annmarie.kelleher@va.gov
Contact: Michelle Oyster, MS (412) 954-5287 ext 5297 tolerico@pitt.edu

Locations
United States, Pennsylvania
VA Pittsburgh Health Care System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Annmarie R Kelleher, MS OTR    412-954-5287 ext 5279    annmarie.kelleher@va.gov   
Contact: Michelle Oyster, MS    (412) 954-5287 ext 5297    tolerico@pitt.edu   
Principal Investigator: Alicia M Koontz, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Alicia M Koontz, PhD VA Pittsburgh Health Care System
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01183546     History of Changes
Other Study ID Numbers: B7149-I
Study First Received: July 16, 2010
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
rehabilitation
spinal cord injury
wheelchairs

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014