Biofeedback for Wheelchair Users

NCT02700178 | Completed

• 1 other identifier: 15-008240
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 6 months

Secondary Outcomes (1)

• change in wrist posture

  approximately 6 months

Study Arms (1)

Biofeedback

EXPERIMENTAL

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

Interventions

Biofeedback OTHER

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.

Biofeedback

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Kristin Zhao, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Assistive and Restorative Technology Laboratory

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 7, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

US (1)