NCT03160612

Brief Summary

The objective of this research study is to 1) evaluate the effectiveness of web based transfer training materials for wheelchair users and 2) determine the reliability of a refined transfer assessment instrument (TAI) as completed by individuals who use wheelchairs for a majority of mobility and clinicians who score transfers in-person and remotely.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2018

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

May 16, 2017

Last Update Submit

January 6, 2025

Conditions

Keywords

WheelchairBiomechanicsTransferTraining

Outcome Measures

Primary Outcomes (1)

  • Change in Transfer Assessment Instrument (TAI) Scores

    Transfer assessment instrument (TAI) scores will be collected both before and after the training to assess for changes in the score.

    Baseline visit and visit 2 (which will occur within 7 days of baseline)

Secondary Outcomes (4)

  • Shoulder pain

    Baseline visit

  • Shoulder pathology

    Baseline Visit

  • Wrist Pain

    Baseline visit

  • Wrist pathology

    Baseline Visit

Study Arms (2)

Case

OTHER

Transfer Training Subjects will be randomized to receive the transfer training either after baseline measures are collected (case) during visit 1.

Behavioral: Transfer Training

Control

OTHER

Transfer Training Subjects will be randomized to receive the transfer training during the follow-up testing at visit 2.

Behavioral: Transfer Training

Interventions

Transfer training interventions will take approximately 1 hour to complete and consist of an interactive web based module that participants interact with which includes text, pictures, videos and time to practice new skills. Additionally, participants will receive an educational handout summarizing the online module.

CaseControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 18
  • Utilizes a wheelchair for the majority of mobility (over 40 hours per week)
  • Ability to transfer independently (may use equipment)
  • Self-report ability to complete a transfer to and from a surface in 30 seconds
  • English speaking

You may not qualify if:

  • Current or recent history (last 3 months) of pressure sores that may be exacerbated by multiple transfers
  • Active use of the lower limb muscles during transfers
  • Upper extremity pain that inhibits the ability to perform transfers or bear weight on the upper extremities
  • Other neurologic condition that could impair learning
  • History of heart or lung conditions that would be made worse by completing up to six back and forth transfers to a mat table

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

Study Officials

  • Michael Boninger, M.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and UPMC Endowed Vice Chair for Research

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 19, 2017

Study Start

June 1, 2015

Primary Completion

July 2, 2016

Study Completion

February 18, 2018

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations