An interventional study of Biofeedback in Spinal Cord Injuries, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science
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.
Participants in the study will be asked to participate in the following during the first (1st) session:
All or a subset of the following activities:
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 10 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals with spinal cord injury (paraplegia and tetraplegia)
Inclusion Criteria:
Exclusion Criteria:
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.
Other: Biofeedback
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
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
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.
Time frame: approximately 6 months
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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