Spinal Cord InjuriesNCT02700178
Biofeedback for Wheelchair Users
A study testing Biofeedback in people with Spinal Cord Injuries, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Development of a Biofeedback Intervention to Reduce the Risk of Upper Extremity Overuse Injury Following Paraplegia and Tetraplegia
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Biofeedback
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 6 months
Secondary outcomes (1)
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.
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Zhao, PhD, Mayo Clinic
- Investigators
- Kristin Zhao, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700178
- Sponsor's protocol ID
- 15-008240
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Biofeedback Intervention to Reduce the Risk of Upper Extremity Overuse Injury Following Paraplegia and Tetraplegia
- ClinicalTrials.gov ID
- NCT02700178
- Acronym / sponsor ID
- 15-008240
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Other: BiofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackThe 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. | Other | Biofeedback |
Primary outcome
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.
1 secondary outcome
change in wrist posture
Time frame: approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Zhao, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Spinal Cord Injuries, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in risk of shoulder impingement (time frame: approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.