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

22 Participants Needed

Trial Summary

What is the purpose of this trial?

So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.

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.

What data supports the effectiveness of the treatment Remote CMR, Cognitive Multisensory Rehabilitation, Remote Cognitive Multisensory Rehabilitation, CMR 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, combining standard cognitive approaches with virtual reality has shown positive outcomes in cognitive and motor skills for spinal cord injury patients. ^{1 2 3 4 5}

Is Remote Multisensory Rehabilitation for Spinal Cord Injury safe for humans?

The available research does not provide specific safety data for Remote Multisensory Rehabilitation, but studies on similar telemedicine and virtual reality interventions for spinal cord injury suggest they are generally safe and feasible for monitoring and rehabilitation purposes. ^{1 2 3 4 5}

How is the Remote CMR treatment different from other treatments for spinal cord injury?

Remote CMR is unique because it uses telemedicine to deliver cognitive and multisensory rehabilitation remotely, allowing patients to receive therapy at home. This approach is different from traditional in-person rehabilitation as it combines cognitive exercises with sensory feedback and can be accessed without needing to travel to a clinic. ^{1 2 3 5 6}

Eligibility Criteria

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

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

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

Exclusion Criteria

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

Adults with other major medical complications

Pregnant women

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Functional and clinical outcomes of telemedicine in patients with spinal cord injury. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A tele-assessment system for monitoring treatment effects in subjects with spinal cord injury. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Overview of Cochrane Systematic Reviews for Rehabilitation Interventions in Persons With Spinal Cord Injury: A Mapping Synthesis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

TEleRehabilitation Nepal (TERN) for People With Spinal Cord Injury and Acquired Brain Injury: A Feasibility Study. [2022]

6. Switzerland 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. [2022]