A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults With Spinal Cord Injury

NCT ID: NCT05167032

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-31

Brief Summary

To provide an effective treatment for recovery from paralysis and improved quality of life of veterans, military, and civilians with spinal cord injury/disorder (SCI/D). 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 Rehabilitation (CMR) vs. adaptive fitness on sensorimotor function. Objective 1: Determine if 8 weeks of CMR improves sensory and motor function in adults with SCI/D. Objective 2: Determine if 8 weeks of CMR restores brain activity and connectivity related to sensorimotor function in adults with SCI/D.

Detailed Description

About 296,000 Americans with a spinal cord injury/disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function and 26% of adults with SCI receive care through the Veterans Affairs (VA). Motor and sensory impairments, including the loss of awareness of where limbs are in space, greatly compromise functional independence and quality of life. Damage to sensory and motor spinal pathways after SCI/D disrupts the bidirectional communication of sensory and motor information between the brain and the spinal cord, resulting in altered brain function in the sensorimotor cortex. Yet, an in-depth understanding of how exactly SCI/D impairs brain function, sensation and movement is largely unknown. Available treatments show mixed results for sensorimotor recovery, perhaps because it is unclear yet which specific brain areas to target. This highlights a need to develop brain mechanism-based treatments that restore brain function and improve sensation and movement after SCI/D. The investigators' brain imaging studies indicate that connections from two brain areas, the parietal operculum (parts OP1/OP4) and insula, are weaker in adults with SCI/D than in healthy adults. These connections are an essential part of the sensorimotor network. Thus, restoration of those network connections may lead to improved sensorimotor function after SCI/D. Previously, the investigators reported in adults 1-7 years post-stroke that OP1/OP4-insula connectivity restored alongside significantly improved sensorimotor function, by applying a physical therapy approach termed "Cognitive Multisensory Rehabilitation" (CMR). Based on these results, the investigators hypothesize that CMR restores brain connections related to sensorimotor function by strengthening OP1/OP4 and insula connections in adults with SCI/D. For this study, the investigators propose to test the hypothesis by carrying out the following objectives:

Objective 1: Determine if 8 weeks of CMR improves sensory and motor function in adults with SCI/D. The investigators will use quantitative measures used in clinical practice, and EMG testing to quantify changes in sensory and motor function. As secondary outcomes, the investigators will assess mood, life satisfaction, and community integration.

Hypothesis 1. CMR in comparison to adaptive fitness will improve sensorimotor function after SCI/D. Sensorimotor function will be associated with mood, life satisfaction, and community integration.

Objective 2: Determine if 8 weeks of CMR restores brain activity and connectivity related to sensorimotor function in adults with SCI/D. The investigators will assess changes in brain activation and connectivity in response to CMR vs adaptive fitness by resting-state and 4 task-based functional Magnetic Resonance Imaging (fMRI).

Hypothesis 2. CMR will restore OP1/OP4 and insula connectivity with other sensorimotor-related brain areas. These brain function changes will be associated with sensory and motor improvements.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Multisensory Rehabilitation (CMR) Group

After the baseline testing, participants in the CMR group will receive 8 weeks of one-on-one, in-person therapy, 3 times a week, for 45 min. The CMR sessions will be recorded on video.

The participants will undergo clinical assessments and MRI scans at 3 time points: at baseline; a post-intervention after the first 8 weeks of CMR and a clinical assessment (no MRI) at 3 months.

Group Type: EXPERIMENTAL

Cognitive Multisensory Rehabilitation (CMR)

Intervention Type: BEHAVIORAL

The goal of CMR is to restore proprioception (i.e., sense of joint position and movement), body awareness, and awareness of the paralyzed limbs and trunk in space, in order to improve sensory and motor function. For example, CMR tasks will have the participant solve exercises related to: (i) where the legs are situated in space; where the legs are in relation to the pelvis and the upper part of the body (ii) the dimensions and length of the legs, the dimension of the pelvis, and sensation of the pelvis as a central body reference. (iii) the relationship between the left and right side of the body, and the relationship between the pelvis and the feet. Further, improvements in touch and pressure sensation are obtained with (v) texture discrimination tasks, and (vi) discrimination of sponges with varying resistance. Given the importance of sensory feedback for movement, sensory improvements create the opportunity for motor recovery to occur.

Adaptive Fitness Group

After the baseline testing, participants in the adapted fitness group will start with a fitness assessment and then complete a fitness program under supervision for 8 weeks, 3x/week, for 45 min. Staff at the Courage Kenny Rehabilitation Institute will monitor training adherence through a log sheet.

The participants will undergo clinical assessments and MRI scans at 3 times points: at baseline; a post-intervention after the first 8 weeks of adaptive fitness and a clinical assessment (no MRI) at 3 months.

Group Type: ACTIVE_COMPARATOR

Adaptive fitness

Intervention Type: BEHAVIORAL

The Courage Kenny Rehabilitation Institute centers provide access to state-of- the-art adaptive gym equipment in their fitness center to promote fitness and recreation. Equipment includes treadmills, elliptical, NuSteps, SciFit upper body ergometers, Ski Erg and Rowing Machine, Upright and recumbent stationary bicycles, chest press, rear row, leg extension, leg curl, leg press, uppertone, free weights, and kettlebells. The equipment is spaced to allow for movement and is accessible for use from a wheelchair. They allow for transfers and caregiver assistance.

Interventions

Cognitive Multisensory Rehabilitation (CMR)

The goal of CMR is to restore proprioception (i.e., sense of joint position and movement), body awareness, and awareness of the paralyzed limbs and trunk in space, in order to improve sensory and motor function. For example, CMR tasks will have the participant solve exercises related to: (i) where the legs are situated in space; where the legs are in relation to the pelvis and the upper part of the body (ii) the dimensions and length of the legs, the dimension of the pelvis, and sensation of the pelvis as a central body reference. (iii) the relationship between the left and right side of the body, and the relationship between the pelvis and the feet. Further, improvements in touch and pressure sensation are obtained with (v) texture discrimination tasks, and (vi) discrimination of sponges with varying resistance. Given the importance of sensory feedback for movement, sensory improvements create the opportunity for motor recovery to occur.

Intervention Type: BEHAVIORAL

Adaptive fitness

The Courage Kenny Rehabilitation Institute centers provide access to state-of- the-art adaptive gym equipment in their fitness center to promote fitness and recreation. Equipment includes treadmills, elliptical, NuSteps, SciFit upper body ergometers, Ski Erg and Rowing Machine, Upright and recumbent stationary bicycles, chest press, rear row, leg extension, leg curl, leg press, uppertone, free weights, and kettlebells. The equipment is spaced to allow for movement and is accessible for use from a wheelchair. They allow for transfers and caregiver assistance.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Incomplete or complete SCI/D of ≥3 months
• Medically stable.

Exclusion Criteria

• MRI contra-indications (stabilizing hardware is typically MRI safe)
• Uncontrolled seizure disorder
• Cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent individuals from following directions or from learning
• Ventilator dependency
• Other major medical complications
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Van de Winckel, PhD, MSPT, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Medical School Department of Rehabilitation Medicine

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PMR-2021-30498

Identifier Type: -

Identifier Source: org_study_id