Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Kessler Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00785278
First received: November 4, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition
Paraplegia
Upper Limb Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Computationally Quantifying Wheelchair Set-Up to Minimize Peak Shoulder Joint Forces Throughout Manual Wheelchair Propulsion: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Peak shoulder joint forces [ Time Frame: During the propulsive phase of the push stroke at the time of data collection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Propulsion Speed [ Time Frame: Measured during the data collection process ] [ Designated as safety issue: No ]
  • Horizontal and Vertical Axle Placement [ Time Frame: Measured prior to data collection on each test day ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Experienced Wheelchair Users:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • Be between the ages of 18 and 65 years of age.

Exclusion Criteria:

  • 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.
  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: NCT00785278

Contacts
Contact: Sarah R. Dubowsky, Ph.D. 973-243-6838 sdubowsky@kmrrec.org

Locations
United States, New Jersey
Kessler Medical Rehabilitation Research and Education Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Sarah R. Dubowsky, Ph.D.    973-243-6838    sdubowsky@kmrrec.org   
Contact: Andrew M. Kwarciak, M.S.    973-243-6903    akwarciak@kmrrec.org   
Principal Investigator: Sarah R. Dubowsky, Ph.D.         
Sub-Investigator: Gail F. Forrest, Ph.D.         
Sub-Investigator: Trevor A. Dyson-Hudson, M.D.         
Sub-Investigator: Andrew M. Kwarciak, M.S.         
Sub-Investigator: Mathew B. Yarossi, B.S.         
Sub-Investigator: Arvind Ramanujam, M.S.         
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Sarah R. Dubowsky, Ph.D. Kessler Medical Rehabilitation Research and Education Center
  More Information

No publications provided

Responsible Party: Sarah R. Dubowsky, Ph.D., Postdoctoral Fellow, Kessler Medical Rehabilitation Research and Education Center
ClinicalTrials.gov Identifier: NCT00785278     History of Changes
Other Study ID Numbers: R-619-08
Study First Received: November 4, 2008
Last Updated: November 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
Wheelchair Set-Up
Shoulder Joint Forces
Manual Wheelchair Users
Paraplegia
Upper Limb Pain
Secondary Injury to Spinal Cord Injury
Biomechanics

Additional relevant MeSH terms:
Paraplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014