Wheelchair Mobility Assessment of Individuals With Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier:
NCT01204047
First received: September 16, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wheelchair Propulsion Function and Physical Capacity in Persons With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Ability Score [ Time Frame: within a 14 day period ] [ Designated as safety issue: No ]
    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:
  • Muscular strength [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Anaerobic power [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Cardiovascular endurance [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 62
Study Start Date: March 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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
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: NCT01204047

Locations
United States, Florida
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
  More Information

Additional Information:
No publications provided

Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01204047     History of Changes
Other Study ID Numbers: TMP-MN-007
Study First Received: September 16, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 26, 2014