Remote Multisensory Rehabilitation for Spinal Cord Injury

Overseen By Ann Van de Winckel, PhD,MSPT,PT

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Disqualifiers: Uncontrolled seizures, Cognitive impairment, Ventilator dependency, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores an innovative therapy called remote cognitive multisensory rehabilitation (CMR) for people with spinal cord injuries (SCI). The researchers aim to determine if remote CMR can enhance both brain function and daily abilities in individuals with chronic SCI. Participants will either receive the remote CMR treatment or engage in regular remote exercises for comparison. Suitable candidates have had a spinal cord injury for at least three months and are medically stable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in SCI rehabilitation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that in-person cognitive multisensory rehabilitation (CMR) aids brain recovery. Specific safety information for remote CMR is not yet available. However, research on similar online and virtual reality treatments suggests they are usually safe. This trial is in Phase 2, indicating that some initial safety tests have been completed, but more information is needed to fully understand its safety in people. So far, similar treatments have not reported major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Remote Multisensory Rehabilitation (Remote CMR) for spinal cord injury because it offers a novel, at-home rehabilitation approach that integrates multiple sensory inputs. Unlike traditional therapies, which often require in-person sessions and focus on physical exercises alone, Remote CMR leverages technology to deliver a comprehensive rehab experience remotely. This method not only broadens access to rehabilitation for individuals who may face logistical challenges but also aims to enhance recovery by stimulating the nervous system in a more holistic manner.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that remote cognitive multisensory rehabilitation (CMR), which participants in this trial may receive, can significantly improve movement and sensation for people with spinal cord injuries. In earlier studies, CMR enhanced these functions more effectively than regular fitness exercises. Participants also experienced relief from nerve pain, which results from nerve damage. Additionally, CMR has been linked to changes in brain activity, suggesting it might aid in brain healing alongside physical recovery. These findings support CMR as a promising treatment option for spinal cord injury recovery. Meanwhile, another group in this trial will receive remote exercises, serving as a comparator to evaluate CMR's effectiveness. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with spinal cord injury or disease, stable in health, and at least 3 months post-injury. They must be able to follow directions and not have MRI contraindications, uncontrolled seizures, cognitive impairments preventing learning, ventilator dependency, other major medical issues or pregnancy.

Inclusion Criteria

Recruited from Hospitals within the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS), HealthPartners Neuroscience Center, Minneapolis VA Healthcare System, Duluth, and in the community

I am between 18 and 75 years old with a stable spinal cord injury for over 3 months.

Exclusion Criteria

Adults with MRI contra-indications (stabilizing hardware is typically MRI safe)

Adults with other major medical complications

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote cognitive multisensory rehabilitation (CMR) or remote exercises for sensory and motor recovery

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote CMR
• Remote Exercise

Trial Overview The study tests remote cognitive multisensory rehabilitation (CMR) and exercise programs for improving sensory and motor functions in chronic spinal cord injury patients. It aims to demonstrate the effectiveness of CMR delivered remotely and its impact on brain function.

How Is the Trial Designed?

Group I: Remote CMR Experimental Treatment 1 Intervention

adults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention.

Group II: Remote exercises Placebo Group 1 Intervention

adults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Telerehabilitation showed a significant improvement in functional scores for patients with spinal cord injury at the Italian site, with the telemedicine group achieving better results in activities like grooming and dressing compared to standard care.

Patients receiving telerehabilitation reported higher satisfaction with their care across all sites, suggesting that this approach may enhance the overall patient experience post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and clinical outcomes of telemedicine in patients with spinal cord injury. Dallolio, L., Menarini, M., China, S., et al.[2019]

Rehabilitation interventions for individuals with spinal cord injury (SCI) may improve respiratory outcomes and provide pain relief, based on a review of 64 studies involving 2024 participants.

However, there is uncertainty regarding the effectiveness of specific interventions like bodyweight-supported treadmill training and robotic-assisted training on walking speed and capacity, indicating a need for higher quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of Cochrane Systematic Reviews for Rehabilitation Interventions in Persons With Spinal Cord Injury: A Mapping Synthesis. Arienti, C., Patrini, M., Negrini, S., et al.[2023]

A new telemedicine method for measuring balance and leg force in 21 spinal cord injury patients was successfully implemented, allowing for efficient remote assessments that took about 30 minutes to complete.

Significant correlations were found between changes in leg force measured remotely and improvements in sensory and motor functions, suggesting that telemedicine can effectively track patient progress in SCI rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tele-assessment system for monitoring treatment effects in subjects with spinal cord injury. Yozbatiran, N., Harness, ET., Le, V., et al.[2019]

A 60-year-old man with incomplete cervical spinal cord injury showed significant improvements in cognitive function, anxiety, and motor performance after a combined rehabilitation approach that included virtual reality training.

The use of virtual reality rehabilitation systems (VRRS) demonstrated effectiveness in enhancing recovery for patients with both motor and cognitive deficits, suggesting it could be a valuable tool in neurological rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel use of virtual reality in the treatment of cognitive and motor deficit in spinal cord injury: A case report. Maresca, G., Maggio, MG., Buda, A., et al.[2022]

A study involving 12 subjects with incomplete spinal cord injury showed that a home-based virtual reality training system significantly improved lower limb muscle strength, balance, and functional mobility after 4 weeks of training.

Participants reported high motivation and positive changes, with functional mobility improvements lasting for at least 2-3 months after the training, indicating the potential of VR as an effective neurorehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Virtual Reality-Augmented Training Improves Lower Limb Muscle Strength, Balance, and Functional Mobility following Chronic Incomplete Spinal Cord Injury. Villiger, M., Liviero, J., Awai, L., et al.[2022]

The telerehabilitation program in Nepal, involving 97 participants with spinal cord injury (SCI) or acquired brain injury (ABI), showed significant improvements in functional independence, mental health, and quality of life after remote assessments and interventions.

Participants found the program acceptable, appreciating the regular contact with multidisciplinary team professionals and the convenience of avoiding costly travel for rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TEleRehabilitation Nepal (TERN) for People With Spinal Cord Injury and Acquired Brain Injury: A Feasibility Study. Dhakal, R., Baniya, M., Solomon, RM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05870189

Remotely Delivered Cognitive Multisensory Rehabilitation ... Remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999325003429

A Pilot Clinical Trial of Cognitive Multisensory ... 8 weeks of cognitive multisensory rehabilitation (CMR) versus adaptive fitness improves sensory and motor function in adults with spinal cord injury or ...

3. withpower.com withpower.com/trial/phase-2-spinal-cord-injuries-5-2023-d296d

Remote Multisensory Rehabilitation for Spinal Cord Injury Research shows that using telemedicine for spinal cord injury can lead to significant improvements in motor and sensory functions over six months. Additionally, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36798345/

Identifying Body Awareness-Related Brain Network Changes ... Adults with chronic SCI had significant neuropathic pain relief and functional improvements, attributed to the recovery of sensation and movement after CMR.

5. med.umn.edu med.umn.edu/familymedicine/research/programs-centers/rehabilitation-science/labs/brain-body-mind-lab/remotely-delivered-cognitive-multisensory-rehabilitation

Remotely Delivered Cognitive Multisensory Rehabilitation ... We will look at changes in brain function after remote cognitive multisensory rehabilitation compared to remote exercises in people with spinal cord injury and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05870189/remotely-delivered-cognitive-multisensory-rehabilitation-for-sensory-and-motor-recovery-after-spinal-cord-injury

Remotely Delivered Cognitive Multisensory Rehabilitation ... Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury. Last updated: July 5, 2025.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05167032

A Clinical Trial of Cognitive Multisensory Rehabilitation for ... This is a mechanistic Phase I randomized pilot clinical trial in 16 adults with SCI/D. The investigators will compare the effects of Cognitive Multisensory ...