Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery after Spinal Cord Injury
For this study, we will recruit up to 16 adults with spinal cord injury who have a reduction or complete loss of sensation and/or movement in a part of the body, but who can self transfer and push a call button in the MRI scanner.
Participants with spinal cord injury will be randomly divided into one of two treatment groups to receive either 12 weeks of Remote therapist-based Cognitive Multisensory Rehabilitation, which is similar to physical therapy and focuses on body awareness to improve sensation and movement; OR to receive a 12-week Remote Exercise program guided 1 on 1 by an exercise physiologist of HealthPartners. You will not be charged for the rehabilitation or exercises that is part of this research study.
The remote Cognitive Multisensory Rehabilitation (CMR) focuses on restoring your sense of joint position and movement and awareness of your body and affected limbs in space in order to improve sensation and movement. Some of the exercises will involve identifying how your legs are positioned and where they are in space and in relation to other parts of your body, working on your awareness of the relationship between the right and left side of your body and between your feet and pelvis. You will also be asked to identify different textures and softness levels of sponges. If you are assigned to the CMR Therapy group, you will have 12 weeks of 1-on-1 sessions with a physical therapist. You will need to have a care partner present during these sessions.
The remote exercise sessions will be one-on-one with an exercise physiologist via Microsoft Teams. You will also need the help of a caregiver for setting up equipment and help with body positioning. Each session will involve 20 minutes of aerobic exercise, 20 minutes of resistance training, and 5 minutes of flexibility, core exercises, and seated balance training. During the intervention period as well as the 6-month follow-up, Dr. Van de Winckel’s team will call the participants weekly to inquire about:
- How often they have done the remote intervention that week
- Information about the content of the intervention performed that week
- Perceived effects of the interventions
- Use of over-the-counter or prescribed medication for spasms
- Recent illnesses, healthcare utilization and/or recent hospitalizations, and
- Information related to community integration.
We will allow medication prescribed or recommended by their clinical care team throughout the trial, as well as other treatments/therapies related to standard of care.
At two time points (beginning of the study and after the 12-week intervention) participants will have an MRI of the brain to look at brain function before and after training or observation period. This part is required.
At 3 times (beginning of the study, after the 12-week intervention, and at the 6-month follow-up) we will test sensation and movement by testing with a cotton ball, test muscle strength, and do some motor tasks. This will be done in the wheelchair-accessible Brain Body Mind Lab (the lab of the principal investigator, Dr. Van de Winckel). Participants will also complete questionnaires over secure Zoom.
Participants with spinal cord injury will receive $100 upon completion and full participation in the study.
This proposal is a pilot study to identify the feasibility and preliminary effects of a remote cognitive multisensory rehabilitation compared to remote exercises. We will look at changes in brain function after remote cognitive multisensory rehabilitation compared to remote exercises in people with spinal cord injury and look at improvement of sensation and movement.
The total participation period is about 9.5 months.
Schedule of Events
At the Screening/Baseline
This includes:
- Combined HIPAA-Informed consent
- Medical records
- Demographic and general health questionnaires
- Clinical assessment tests and surveys
- Screening for MRI compatibility
- MRI scan
After 12 weeks of remote CMR or remote exercises
This includes:
- Clinical assessment tests and surveys
- Screening for MRI compatibility
- MRI scan
At the 6-month follow-up assessment
This includes:
- Clinical assessment tests and surveys
Study Location | Weekly Evaluations
This includes:
Report on adherence, information about the content of the intervention performed that week, perceived effects of the interventions, the use of over the counter or prescribed medication for spasms, recent illnesses, healthcare utilization and/or recent hospitalizations, and information relating to community integration.
Study Locations
Children's Rehabilitation Center (wheelchair accessible entrance)
426 Church Street SE
Room 302 - Brain Body Mind Lab
Minneapolis, MN 55455
612-625-1191
From Highway I-94 take the Huron Boulevard exit and go north:
-Left on Fulton Street SE
-Continue straight ahead onto East River Parkway
The East River Road Garage Parking Ramp will be on your right.
After parking
-Take the elevator to the first floor to go outside. The Coffman Memorial Union Building is in front of you, the road is Delaware Street SE.
-Turn right to walk on Delaware St SE and take another right on Church St SE.
-We will meet you at the front entrance of the Children's Rehabilitation Building. We will then go to the Brain Body Mind Lab (3rd floor, Room 302).
If stairs are not an obstacle, you can also walk out of the East River Road Garage (Level C) and walk back to the East River Road Parkway, up the hill, to the first adjacent building on your left. This is the back entrance of the Children's Rehabilitation Center. We will wait for you at this door.
Brain Body Mind Lab (Room 302)
Center for Magnetic Resonance Research
Address: 2021 6th St SE, Minneapolis, MN 55455
FAQ's
What do researchers hope to learn?
Researchers have found that some parts of the brain related sensation, movement, and body awareness, function differently in adults who have sustained a spinal cord injury. We would like to compare the effect of remote cognitive multisensory rehabilitation versus remote exercises and investigate what parts in the brain help improve sensation and movement.
How will participating in this study help?
This research helps us understand how remote cognitive multisensory rehabilitation or remote exercises help people with spinal cord injury regain function and sensation. Understanding the brain function could potentially also help future research.
How do I need to be dressed?
Loose fitting clothing would be fine. We recommend you wear clothing in which you are comfortable.
Do I have to take a break from other activities/therapies to participate?
You can continue any activities that you were doing beforehand. We will ask you not to start any sport or other body awareness training (martial arts, dance, Tai Chi) or exercise or therapy specifically for improving sensation or movement during the study period unless medically necessary. If so, please inform the principal investigator of this study immediately (Dr. Ann Van de Winckel, [email protected]).
What are the characteristics of participants you are looking for?
Participants (18-70 years of age) with spinal cord injury that results in reduction or loss of movement and sensation.
Participants, who have cognitive problems, are unable to speak or understand instructions, who have nerve problems, fractures or infections, vision problems, or problems with imagining movements, or who do not speak English will not be recruited. If you are not sure if you are eligible, feel free to contact us. We are also unable to include international participants.
How will I benefit from participating?
There may be no direct benefit to participating in this study, but you could benefit from the cognitive multisensory rehabilitation or exercise and experience improved sensation or movement. In any case, the information from this study may help other people in the future.
Does this cost money to participate?
There is no charge to participate, except to cover your transport for in-person testings. We will cover your parking and all test and therapy sessions. You will get $100 after attending and completing all test and therapy sessions.
I'm working full-time/in shifts. Can I come before/after my work?
While we cannot always promise a perfect match, we will do our best to plan our assessment visits around your working schedule. However, the remote sessions will occur between 9am-5pm. The MRI sessions can also only be scheduled during workdays and work hours (7am-5pm) and depending on the availability of the MRI scanner. Therapy sessions will be during work hours.
Principal Investigators (PI):
Ann Van de Winckel, PhD, MSPT, PT
Contact
[email protected]
Interested in Participating?
This study takes about 9.5 months which includes 12 weeks of remote therapy or remote exercises 3x/week at the University of Minnesota +
in-person MRI (twice) and testing and movement and sensation (3 times).
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