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

NCT ID: NCT00785278

Last Updated: 2008-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Paraplegia Upper Limb Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Wheelchair Set-Up Shoulder Joint Forces Manual Wheelchair Users Paraplegia Upper Limb Pain Secondary Injury to Spinal Cord Injury Biomechanics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


* 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;
* 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:


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kessler Medical Rehabilitation Research and Education Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah R. Dubowsky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Medical Rehabilitation Research and Education Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kessler Medical Rehabilitation Research and Education Center

West Orange, New Jersey, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah R. Dubowsky, Ph.D.

Role: CONTACT

Phone: 973-243-6838

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sarah R. Dubowsky, Ph.D.

Role: primary

Andrew M. Kwarciak, M.S.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R-619-08

Identifier Type: -

Identifier Source: org_study_id