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

NCT05167032 | Completed

• 1 other identifier: PMR-2021-30498
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• Change in Brain Motor Control Assessment (BMCA)

  The EMG testing will be done with the BMCA. The BMCA protocol involves elements of relaxation, reinforcement, and voluntary movements to gather quantitative multichannel surface EMG data. BMCA will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment. Assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.

  3 Months

• Change in ISNCSCI Neurologic exam (ASIA test)

  The ASIA test is a clinical test originally designed to describe the extent and severity of a patient's SCI/D. It consists of a pinprick sensory test (sharp versus dull with a safety pin); a touch sensory test (with a cotton ball) and a test of the strength of muscles. Each sensation test is scored from 0-54 right and left, and the muscle tests for upper and lower limbs are scored from 0-25 each. Higher scores indicate better function. The ASIA test will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.

  3 Months

• Change in Neuromuscular Recovery Scale (NRS)

  The NRS includes 11 items rated from 1-4 focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. Higher scores indicate better performance. The NRS provides a functional recovery measure that focuses on non-compensatory recovery. The NRS will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.

  3 Months

• Change in Spinal Cord Injury Functional Index/Assistive Technology (SCI-FI/AT)

  The SCI-FI/AT consists of 32 items each rated from 0-4, where higher scores indicate better function. It reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation. The SCI-FI/AT will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.

  3 Months

• Change in International Spinal Cord Injury Pain Basic Set Version 2.0 (SCI Pain Test) which includes the numerical pain rating scale

  The SCI Pain Test consists of a numeric pain rating scale with scores ranging from 0-10 where lower scores indicate less pain, and an assessment of interference of pain with daily activity, mood, and sleep, with scores ranging from 0-10 where lower scores indicate less interference in daily life. The SCI Pain Test will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.

  3 Months

Secondary Outcomes (10)

• Change in Pittsburgh Sleep Quality Index

  3 Months

• Change in Spielberger State Trait Anxiety Inventory

  3 Months

• Change in Patient Health Questionnaire (PHQ-9)

  3 Months

• Change in World Health Organization Quality of Life Instruments (WHOQOL-BREF)

  3 Months

• Change in Revised Body Awareness Rating Questionnaire

  3 Months

Study Arms (2)

Cognitive Multisensory Rehabilitation (CMR) Group

EXPERIMENTAL

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.

Behavioral: Cognitive Multisensory Rehabilitation (CMR)

Adaptive Fitness Group

ACTIVE COMPARATOR

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.

Behavioral: Adaptive fitness

Interventions

Cognitive Multisensory Rehabilitation (CMR) 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.

Cognitive Multisensory Rehabilitation (CMR) Group

Adaptive fitness 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.

Adaptive Fitness Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ann Van de Winckel, PhD, MSPT, PT

  University of Minnesota Medical School Department of Rehabilitation Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 22, 2021
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)