Biofeedback for Wheelchair Users
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|ClinicalTrials.gov Identifier: NCT02700178|
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Other: Biofeedback||Not Applicable|
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)
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Development of a Biofeedback Intervention to Reduce the Risk of Upper Extremity Overuse Injury Following Paraplegia and Tetraplegia|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
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.
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.
- change in risk of shoulder impingement [ Time Frame: approximately 6 months ]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.
- change in wrist posture [ Time Frame: approximately 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700178
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Kristin D Zhao, Ph.D 507-284-8942 Zhao.Kristin@mayo.edu|
|Principal Investigator:||Kristin Zhao, PhD||Mayo Clinic|