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Wheelchair Mobility Assessment of Individuals With Spinal Cord Injury

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT01204047
Collaborator
(none)
62
Enrollment
1
Location
47
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The specific aims of this study are: 1) to assess the test-retest reliability of a modification of an existing wheelchair propulsion assessment and 2) validate the modification against traditional measures of physical strength, power, and endurance in a group of persons with spinal cord injury (SCI).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The ability to independently self-propel and transfer oneself is a crucial component of daily life for individuals with a spinal cord injury. This ability is related in part to an individual's strength, power, and endurance, but it is unknown which of these measures is most important to achieve a high level of wheelchair function. Identification of which physical performance parameters are best related to wheeled mobility performance is essential in developing interventions to improve said performance. Currently, clinic-friendly assessments of a person's wheeled mobility ability do not exist. We have developed a modified, clinic-friendly version of validated wheelchair mobility assessment that can be completed in most clinics. Before it can be implemented by clinicians its reliability must be established. Crossvalidating it against standard measures of physical performance will allow for the identification of the most appropriate exercise interventions to improve independent wheeled mobility.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    62 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Wheelchair Propulsion Function and Physical Capacity in Persons With Spinal Cord Injury
    Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2012
    Actual Study Completion Date :
    Feb 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Ability Score [within a 14 day period]

      The ability score is the sum of the number of items successfully completed in the wheelchair propulsion assessment. There are 8 items in the assessement, which will be completed in the following order: 1) Figure of 8 Shape, 2) Doorstep Crossing, 3) Platform Ascent, 4) 15 meter sprint, 5) Ramp Ascent (5% grade), 6) Ramp Ascent (8% grade), 7) 150 meter propulsion, and 8) Timed Level Transfer.

    Secondary Outcome Measures

    1. Muscular strength [1 day]

      Upper extremity dynamic strength testing will be performed on a Helms equalizer 1000 multi-station exerciser using the following maneuvers: overhead press, horizontal row, vertical butterfly, biceps curl, latissimus pull down (either to the chest or neck), and dips. The 1-repetition maximum (1-RM) will be calculated using the Mayhew regression equation.

    2. Anaerobic power [1 day]

      Participants will propel a table-mounted Monark 894e ergometer for 30 seconds at maximal speed against constant force. The constant resistance for each subject will be set at 1.5% and 3.5% of their body mass, for tetraplegia and paraplegia respectively. Data for three variables will be obtained: a) peak power, defined as the highest average mechanical power measured during any 5-second period, b) mean power, the average power sustained during the 30-second test period, and c) rate of fatigue, defined as the degree of power drop-off during the test.

    3. Cardiovascular endurance [1 day]

      Endurance will be measured using a calibrated upper arm ergometer. An initial exercise workload of 0 Watts at 60 revolutions per minute (RPM) for three minutes will be followed by three minute stages increasing in 20 Watt increments. Responses to exercise will be continuously monitored via open-circuit spirometry and 12-lead electrocardiography. Peak Work will be defined as volitional fatigue, inability to maintain targeted workload, or the point at which increasing workload fails to further increase VO2.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Spinal Cord Injury

    • American Spinal Injury Association Impairment Scale (AIS) A-D

    • Self-reported ability to self-propel themselves in a manual wheelchair

    • Age 18 or older

    Exclusion Criteria:

    • surgery within 6 months

    • pressure ulcer within 3 months

    • upper limb pain that limits completion of exercise

    • recurrent acute infection or illness requiring hospitalization or IV antibiotics

    • pregnancy

    • previous myocardial infarction or cardiac surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Miami Project to Cure Paralysis Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT01204047
    Other Study ID Numbers:
    • TMP-MN-007
    First Posted:
    Sep 17, 2010
    Last Update Posted:
    Jul 22, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 22, 2014