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Spinal Cord InjuryNCT01183546

Biomechanical Validation of the Transfer Assessment Instrument (TAI)

An observational study of Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury
How many people
53 participants
Where
1 siteUnited States
Study dates
Aug 2012to Dec 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

  • For preliminary phase (control subjects)
  • 18 years old or over
  • 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)
  • 18 years old or over
  • C4 level or below spinal cord injury
Show all 9Show fewer
  • Ability to perform an independent transfer (without assistive device or human assistance)
  • Manual wheelchair user For preliminary phase (control subjects)
  • No significant upper extremity pain or injury that would inhibit the ability to perform transfers or weight bear on the upper extremities.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Pittsburgh Health Care System

    Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

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.

Read the 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.

Keywords
rehabilitation, spinal cord injury, wheelchairs
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01183546
Study groupRoleWhat they receive
Wheelchair Users with Spinal Cord Injurywheelchair users with spinal cord injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transfer Performance (TAI Scores Part 1)

    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.

    Measured: Baseline Testing and at Followup Testing (4 weeks)

Secondary outcomes (1)
  1. Shoulder Peak Resultant Moment

    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.

    Measured: Baseline Testing and at Followup Testing (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2010 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01183546
Sponsor's protocol ID
B7149-I
Status last verified
Feb 2016
First submitted
16 Jul 2010
Last updated
10 Mar 2016
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transfer Performance (TAI Scores Part 1) (time frame: Baseline Testing and at Followup Testing (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.

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