Remote Multisensory Rehabilitation for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Minnesota

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

Prior Safety Data

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

Trial 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 (Behavioral Intervention)
• Remote Exercise (Behavioral)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Minnesota Minneapolis, MN

Who Is Running the Clinical Trial?

University of Minnesota Lead Sponsor

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] Aim of this study is to evaluate the cognitive and motor outcomes after a combined rehabilitative training using a standard cognitive approach and virtual reality (VR), in a patient with spinal cord injury (SCI).

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

Functional and clinical outcomes of telemedicine in patients with spinal cord injury. [2019] To compare the 6-month outcomes of telerehabilitation intervention with those of standard care for spinal cord injury (SCI).

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

A tele-assessment system for monitoring treatment effects in subjects with spinal cord injury. [2019] We developed a method for remote measurement of balance and leg force in patients with spinal cord injury (SCI). In a group of 21 patients, both telemedicine and conventional clinical assessments were conducted at baseline and six months later. Telemedicine assessments were successfully acquired and transmitted at first attempt. The time required to set up the telemedicine equipment, position the subject, perform the measurements, and then send the data to the university laboratory was approximately 30 minutes. After six months, several motor and sensory functions showed significant changes. There were significant correlations between changes in remotely-measured leg force and changes in several of the American Spinal Injury Association (ASIA) sensory and motor scores. Changes in balance did not show any significant correlations with changes in the ASIA scores. Intra-rater reliability was better than inter-rater reliability. Use of telemedicine to remotely monitor changes in patients with SCI appears promising.

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] This article aims to describe the evidence on rehabilitation interventions for persons with spinal cord injury (SCI) identified in Cochrane Systematic Reviews (CSRs) selected for inclusion in the World Health Organization Rehabilitation Programme-Package of Interventions for Rehabilitation.

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

TEleRehabilitation Nepal (TERN) for People With Spinal Cord Injury and Acquired Brain Injury: A Feasibility Study. [2022] Spinal Cord Injury (SCI) or Acquired Brain Injury (ABI) leads to disability, unemployment, loss of income, decreased quality of life and increased mortality. The impact is worse in Low-and Middle-Income Countries (LMICs) due to a lack of efficient long-term rehabilitative care. This study aims to explore the feasibility and acceptability of a telerehabilitation programme in Nepal.

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] Key factors positively influencing rehabilitation and functional recovery after spinal cord injury (SCI) include training variety, intensive movement repetition, and motivating training tasks. Systems supporting these aspects may provide profound gains in rehabilitation, independent of the subject's treatment location. In the present study, we test the hypotheses that virtual reality (VR)-augmented training at home (i.e., unsupervised) is feasible with subjects with an incomplete SCI (iSCI) and that it improves motor functions such as lower limb muscle strength, balance, and functional mobility. In the study, 12 chronic iSCI subjects used a home-based, mobile version of a lower limb VR training system. The system included motivating training scenarios and combined action observation and execution. Virtual representations of the legs and feet were controlled via movement sensors. The subjects performed home-based training over 4 weeks, with 16-20 sessions of 30-45 min each. The outcome measures assessed were the Lower Extremity Motor Score (LEMS), Berg Balance Scale (BBS), Timed Up and Go (TUG), Spinal Cord Independence Measure mobility, Walking Index for Spinal Cord Injury II, and 10 m and 6 min walking tests. Two pre-treatment assessment time points were chosen for outcome stability: 4 weeks before treatment and immediately before treatment. At post-assessment (i.e., immediately after treatment), high motivation and positive changes were reported by the subjects (adapted Patients' Global Impression of Change). Significant improvements were shown in lower limb muscle strength (LEMS, P = 0.008), balance (BBS, P = 0.008), and functional mobility (TUG, P = 0.007). At follow-up assessment (i.e., 2-3 months after treatment), functional mobility (TUG) remained significantly improved (P = 0.005) in contrast to the other outcome measures. In summary, unsupervised exercises at home with the VR training system led to beneficial functional training effects in subjects with chronic iSCI, suggesting that it may be useful as a neurorehabilitation tool.