Effects of In-Wheel Suspension

NCT04467749 | Completed

• 1 other identifier: STUDY20020199
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Manual wheelchairs allow individuals with spinal cord injuries (SCI) to safely and effectively access their environment. However, continual exposure to whole body vibration (WBV) is one of many contributing factors to neck pain, back pain, and fatigue in wheelchair users with SCI. Vibration-reducing in-wheel suspension has the potential to mitigate issues associated with long-term manual wheelchair propulsion. Evidence is lacking on how well these systems work for reducing harmful shock and vibration, pain and fatigue. The purpose of this study is to examine how these wheels change the vibration levels manual wheelchair users are exposed to and how they impact pain and fatigue.

Conditions

Spinal Cord Injuries; Fatigue; Back Pain; Neck Pain

Outcome Measures

Primary Outcomes (4)

• Vibrational Dose Value (VDV)

  Amount of whole body vibration exposure in units of meters/sec to power of 1.75) computed using a 3-axis accelerometer attached to wheelchair on the obstacle course.

  Baseline Visit (Phase 1 Primary Outcome)

• Changes in Neck Pain

  Measured using the Numerical Rating Scale (NRS). The NRS measures amount of pain experienced in a body part over the last 24 hours on a scale of 0 = no pain to 10 = pain as bad as you can imagine.

  Baseline and 12-weeks (Phase 2 Primary Outcome)

• Changes in Upper Back Pain

  Measured using the Numerical Rating Scale (NRS). The NRS measures amount of pain experienced in a body part over the last 24 hours on a scale of 0 = no pain to 10 = pain as bad as you can imagine.

  Baseline and 12-weeks (Phase 2 Primary Outcome)

• Changes in Fatigue

  Measured using the Daily Questionnaire for Pain and Fatigue. Four questions ask specifically about fatigue experienced when using the wheelchair in and outside of the home and on smooth and uneven surfaces. The scale ranges from 0 = no fatigue to 3 = extreme fatigue.

  Baseline and 12-weeks (Phase 2 Primary Outcome)

Secondary Outcomes (1)

• Changes in Mobility Participation in the Community

  Baseline and 12-weeks (Phase 2 Secondary Outcome)

Study Arms (1)

Suspension Wheel

EXPERIMENTAL

Participants will be given a set of in-wheel suspension wheels to use in their normal daily routine for three months.

Other: Suspension Wheel

Interventions

Suspension Wheel OTHER

Participants will be given a pair of Spinergy or Loopwheels to use during the 12-week intervention period. The Spinergy wheels consist of a lightweight carbon fiber material with natural shock absorbing properties. Loopwheels offer a rigid rim, a mid-wheel shock absorbing hub and three in-wheel loops that work as a self-correcting system when encountering uneven ground.

Also known as: Spinergy or Loopwheel

Suspension Wheel

Eligibility Criteria

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

You may qualify if:

• have neurological impairment secondary to a traumatic SCI
• have a SCI which occurred or was diagnosed over one year prior to the start of the study
• uses a manual wheelchair as a primary means of mobility (at least 30 hours per week but not necessarily always in motion)
• uses a manual wheelchair with 24- or 25-inch quick release wheels
• uses a manual wheelchair that does not have suspension elements in the frame,
• weighs under 265 pounds (maximum weight limit of the suspension wheels),
• has moderate chronic neck and/or back pain.
• proficient in English

You may not qualify if:

• History of fractures or dislocations in the shoulder, elbow and wrist from which the participant has not fully recovered (i.e. the participant may no longer experience pain or limited/altered function due to the injury)
• upper limb pain that interferes with the ability to propel,
• severe cognitive limitations,
• current or recent (within the last 6 months) history of pressure sores.

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Fatigue; Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Alicia Koontz, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: July 14, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be immediately available post acceptance date of the study related publication and for a period of 5 years.
• Access Criteria: Requesters must provide methodologically sound aims and proposal describing use of the data. They also need to sign a data access agreement.

Locations

US (1)