NCT00785278

Brief Summary

Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. As a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing injuries and maintaining comfort during locomotion. The purpose of this research study is to create a subject-specific computer model of wheelchair propulsion to provide information on wheelchair set-up (in particular, axle placement). The primary objective of this study is to investigate the effect of wheelchair set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to develop a predictive model to identify differences in shoulder joint forces that result from altering the axle position and seating set-up in user's wheelchairs. The hypothesis of the study is that outputs from a patient-specific model will reveal that the current axle position for each subject results in peak shoulder joint forces that are greater than those predicted from an altered axle position (determined by the model). The overall goal is to then adjust each manual wheelchair user's axle placement to one that minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may be reduced, prolonging a pain-free way of life for this population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 5, 2008

Status Verified

November 1, 2008

Enrollment Period

1.3 years

First QC Date

November 4, 2008

Last Update Submit

November 4, 2008

Conditions

Keywords

Wheelchair Set-UpShoulder Joint ForcesManual Wheelchair UsersParaplegiaUpper Limb PainSecondary Injury to Spinal Cord InjuryBiomechanics

Outcome Measures

Primary Outcomes (1)

  • Peak shoulder joint forces

    During the propulsive phase of the push stroke at the time of data collection

Secondary Outcomes (2)

  • Propulsion Speed

    Measured during the data collection process

  • Horizontal and Vertical Axle Placement

    Measured prior to data collection on each test day

Study Arms (2)

1

Able-bodied participants: Able-bodied individuals will be asked to propel a wheelchair at a self-selected speed for a period of time during which data will be collected on their propulsion biomechanics. It is assumed, for the purpose of the study, that un-learned able-bodied individuals learning to propel a wheelchair reflect newly injured individuals who are just getting accustomed to a new chair.

2

Participants with paraplegia: Individuals who are at least 1-year post injury and have used a manual wheelchair as their primary means of locomotion during this time, will be assumed to be, for the purpose of this study, experienced wheelchair users.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of Northern New Jersey and the surrounding area and/or the patient population of the Kessler Medical Rehabilitation Research and Education Center (KMRREC). Subjects will be recruited from database search and word of mouth.

You may qualify if:

  • Have a neurological impairment secondary to a spinal cord injury which occurred over 1 year prior to the start of the study;
  • SCI at or below T1 (complete or incomplete);
  • Use a manual wheelchair as a primary means of mobility (at least 40 hrs. per week but not necessarily always in motion);
  • SCI after age 18
  • Have 24 inch diameter wheels with quick-release axles.

You may not qualify if:

  • History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
  • Upper limb dysthetic pain as a result of a syrinx or reflex sympathetic dystrophy;
  • Pregnant women;
  • Shoulder pain that a MWU describes as limiting their ability to propel a manual wheelchair;
  • History of neurologic disorder other than spinal cord injury (e.g. brain injury).
  • Inexperienced Manual Wheelchair Users:
  • Be between the ages of 18 and 65 years of age.
  • History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
  • Have a musculoskeletal disorder;
  • Pregnant women;
  • Shoulder pain that limits their ability to propel a manual wheelchair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Medical Rehabilitation Research and Education Center

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Paraplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah R. Dubowsky, Ph.D.

    Kessler Medical Rehabilitation Research and Education Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah R. Dubowsky, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

July 1, 2010

Last Updated

November 5, 2008

Record last verified: 2008-11

Locations