Biomechanical Validation of the Transfer Assessment Instrument (TAI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01183546
First received: July 16, 2010
Last updated: February 11, 2016
Last verified: February 2016
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • Transfer Performance (TAI Scores Part 1) [ Time Frame: Baseline Testing and at Followup Testing (4 weeks) ] [ Designated as safety issue: No ]
    Part 1 of the TAI is comprised of 15 items which are scored "yes" (1 point) when the subject performs the specified skill correctly and "no" (0 points) when the subject performs the skill incorrectly or "(N/A)" which means the item does not apply. The part 1 summary score is the summation of each item's score multiplied by 10, and then divided by the number of applicable items, ranging from 0 to 10.


Secondary Outcome Measures:
  • Shoulder Peak Resultant Moment [ Time Frame: Baseline Testing and at Followup Testing (4 weeks) ] [ Designated as safety issue: No ]
    Shoulder Peak Resultant Moment during wheelchair transfers was calculated using an inverse dynamics model approach. Inputs into the model included forces recorded at the hands during transfers, three-dimensional motion trajectories of markers placed on the upper limbs and trunk, and subject's anthropometric data.


Enrollment: 53
Study Start Date: August 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Wheelchair Users with Spinal Cord Injury
wheelchair users with 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, 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
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.
  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

Locations
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Alicia M Koontz, PhD VA Pittsburgh Health Care System
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01183546     History of Changes
Other Study ID Numbers: B7149-I 
Study First Received: July 16, 2010
Results First Received: January 8, 2016
Last Updated: February 11, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
rehabilitation
spinal cord injury
wheelchairs

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

ClinicalTrials.gov processed this record on August 25, 2016