Wheelchair Backs That Support the Spinal Curves

NCT05068648 | Completed

• 1 other identifier: IRB#1788302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The overall objective of this fully powered clinical trial is to investigate if using a solid backrest on a manual wheelchair (MWC) will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest, and to explore the impact of overall back height, contour, and seat gap when using a solid backrest in individuals with spinal cord injury (SCI).

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Pelvic Angle

  Throughout study completion; average of 2 years.

• Frontal Pelvic Angle

  Throughout study completion; average of 2 years.

Secondary Outcomes (6)

• Spinal Angle of Kyphosis

  Throughout study completion; average of 2 years.

• Frontal Sternal Angle

  Throughout study completion; average of 2 years.

• Vertical Forward Reach Test (VFRT)

  Throughout study completion; average of 2 years.

• One Stroke Push Test

  Throughout study completion; average of 2 years.

• Timed Forward Wheeling

  Throughout study completion; average of 2 years.

Study Arms (5)

MWC Configuration 1

ACTIVE COMPARATOR

standard upholstery back that promotes posterior pelvic tilt set at or below cushion level and 1" above inferior angle

Other: Manual Wheelchair (MWC) backrest configuration

MWC Configuration 2

ACTIVE COMPARATOR

active contour back positioned with seat gap and with free scapulae

Other: Manual Wheelchair (MWC) backrest configuration

MWC Configuration 3

ACTIVE COMPARATOR

active contour back positioned with seat gap and with blocked scapulae

Other: Manual Wheelchair (MWC) backrest configuration

MWC Configuration 4

ACTIVE COMPARATOR

deep contour back positioned with seat gap and with free scapulae

Other: Manual Wheelchair (MWC) backrest configuration

MWC Configuration 5

ACTIVE COMPARATOR

deep contour back positioned without seat gap and with free scapulae

Other: Manual Wheelchair (MWC) backrest configuration

Interventions

Manual Wheelchair (MWC) backrest configuration OTHER

Wheelchair backrest fitting, postural and functional assessment

MWC Configuration 1; MWC Configuration 2; MWC Configuration 3; MWC Configuration 4; MWC Configuration 5

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Full time manual wheelchair users
• Motor complete SCI from C6-T4
• Age 18-70 at time of testing
• Time since injury \> 3 month at time of testing

You may not qualify if:

• Weight \>250 pounds
• Current pressure ulcer at time of testing
• Significant shoulder pain that precludes independent mobility at time of testing
• Insufficient range of motion to achieve neutral pelvis and spine at time of testing
• Orthopedic restrictions requiring a brace that would impact functional outcome measures
• Shoulder flexion range of motion \<120 degrees at time of testing
• PSIS-to-Inferior Angle of scapula measurement less than 8 inches or greater than 16 inches
• Cognitive deficits or visual impairment that would impair ability to give informed consent or to follow simple instructions during testing
• Children, pregnant women and prisoners will not participate in this study

Sponsors & Collaborators

• Craig Hospital: lead
• Kessler Institute for Rehabilitation: collaborator
• Shirley Ryan AbilityLab: collaborator

Study Sites (3)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of Research and Evaluation

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 6, 2021
• Study Start: December 1, 2021
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: February 24, 2025

Record last verified: 2024-08

Locations

US (3)