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Biofeedback for Wheelchair Users

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Individuals with spinal cord injury (paraplegia and tetraplegia)

Inclusion Criteria:

  1. Age 18-60 at time of enrollment
  2. Spinal cord injury or disease leading to paraplegia or tetraplegia
  3. Uses a manual wheelchair as primary mode of mobility
  4. Independently mobile enough to participate in the study
  5. Active shoulder and wrist range of motion within limits needed for the tasks performed during the study

Exclusion Criteria:

  1. Surgery or significant injury to the shoulder(s) or wrist(s) of interest (such as dislocation, fracture or full rotator cuff tear) in which return to pre-injury functional status was NOT attained
  2. Peripheral nerve impairment of the upper extremity being tested
  3. Evidence of significant denervation of multiple scapular muscles
  4. Shoulder or wrist instability on the upper extremity to be tested
  5. Allergy to medical grade adhesive tape (used to secure sensors to skin)

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biofeedback

Arm Description

Participants will be asked to participate in all or a subset of daily activities for wheelchair users. The intervention will consist of visual and/or auditory cues to guide their movement while performing the tasks during one to two sessions.

Outcomes

Primary Outcome Measures

change in risk of shoulder impingement
Risk of shoulder impingement, based on the relative orientation of the humerus and scapula during activities of daily living, will be evaluated at the first appointment and following the biofeedback intervention. The change in this outcome will be evaluated for significance.

Secondary Outcome Measures

change in wrist posture
Wrist posture, the position of the hand relative to the forearm, during high levels of loading will be evaluated at the first appointment and following the biofeedback intervention. The change in this outcome will be evaluated for significance.

Full Information

First Posted
February 17, 2016
Last Updated
February 16, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02700178
Brief Title
Biofeedback for Wheelchair Users
Official Title
Development of a Biofeedback Intervention to Reduce the Risk of Upper Extremity Overuse Injury Following Paraplegia and Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate movement of the arm and forces put through the hand during activities performed in a manual wheelchair. The goal of this study is to identify what motions and forces are most likely to lead to the development of pain or pathology and determine the feasibility of strategies to modify movements and decrease risk.
Detailed Description
Participants in the study will be asked to participate in the following during the first (1st) session: Physical exam assessing joint motion Questionnaires asking about shoulder pain All or a subset of the following activities: Level wheelchair propulsion for up to 10 minutes Ramp wheelchair propulsion Lifting the wheelchair, including into a car (simulated car in therapy area) Transferring in/out of the wheelchair Overhead tasks (such as lifting an object off a shelf) Reaching During the next session(s), participants will be asked to participate in all or a subset of the activities listed above (3a-3f) and will also be guided through a biofeedback intervention. The intervention will consist of visual and/or auditory cues to guide movement while performing the tasks. The visual biofeedback will consist of line or shape targets on a screen that are the participant's goal to achieve with their movements. The auditory cues will be a tone or multiple tones to alert the participant when to move and/or when targets have been achieved. During the biofeedback session the study staff may also provide verbal cues and feedback. The investigators may review the medical records of the participants to obtain information about their spinal cord injury, wheelchair and any injury to their muscles, ligaments, bones or nerves. During all sessions, and prior to performing the activities listed (3a-3f), motion sensors will be applied to the skin overlying the participant's sternum (chest), shoulder blade, via a plastic cuff on the arm just above the elbow, and wrist using medical grade adhesive tape. Sensors that detect muscle activity may also be applied to the skin of the participant's arm. Sensors that detect force applied by the participant's arm will also be used. Force will be detected using all or a subset of the following tools: exchanging one of the wheels on the participant's wheelchair for one of the same size that detects force, having the participant wear a glove that detects force, and using a mat that detects force. The activities completed while in this study may be photographed or videotaped.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
Participants will be asked to participate in all or a subset of daily activities for wheelchair users. The intervention will consist of visual and/or auditory cues to guide their movement while performing the tasks during one to two sessions.
Intervention Type
Other
Intervention Name(s)
Biofeedback
Intervention Description
The visual biofeedback will consist of line or shape targets on a screen that the participants will aim to achieve with your movements. The auditory cues will be a tone or multiple tones to alert them when to move and/or when targets have been achieved. During the biofeedback session the study staff may also provide verbal cues and feedback.
Primary Outcome Measure Information:
Title
change in risk of shoulder impingement
Description
Risk of shoulder impingement, based on the relative orientation of the humerus and scapula during activities of daily living, will be evaluated at the first appointment and following the biofeedback intervention. The change in this outcome will be evaluated for significance.
Time Frame
approximately 6 months
Secondary Outcome Measure Information:
Title
change in wrist posture
Description
Wrist posture, the position of the hand relative to the forearm, during high levels of loading will be evaluated at the first appointment and following the biofeedback intervention. The change in this outcome will be evaluated for significance.
Time Frame
approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Individuals with spinal cord injury (paraplegia and tetraplegia) Inclusion Criteria: Age 18-60 at time of enrollment Spinal cord injury or disease leading to paraplegia or tetraplegia Uses a manual wheelchair as primary mode of mobility Independently mobile enough to participate in the study Active shoulder and wrist range of motion within limits needed for the tasks performed during the study Exclusion Criteria: Surgery or significant injury to the shoulder(s) or wrist(s) of interest (such as dislocation, fracture or full rotator cuff tear) in which return to pre-injury functional status was NOT attained Peripheral nerve impairment of the upper extremity being tested Evidence of significant denervation of multiple scapular muscles Shoulder or wrist instability on the upper extremity to be tested Allergy to medical grade adhesive tape (used to secure sensors to skin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Zhao, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Biofeedback for Wheelchair Users

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