Spinal Cord InjuriesNCT05167032
A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults With Spinal Cord Injury
A study testing Cognitive Multisensory Rehabilitation (CMR) and Adaptive fitness in people with Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Cognitive Multisensory Rehabilitation (CMR) and Adaptive fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incomplete or complete SCI/D of ≥3 months
- Medically stable.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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
- Being tested
- Cognitive Multisensory Rehabilitation (CMR), Adaptive fitness
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Multisensory Rehabilitation (CMR)Behavioural
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 fitnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Adaptive fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 Months
Secondary outcomes (10)
Change in Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index consists of 7 components with total scores ranging from 0-21, where lower scores indicate less difficulty in the assessed areas. The Pittsburgh Sleep Quality Index will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in Spielberger State Trait Anxiety Inventory
The Speilberger State Trait Anxiety Inventory consists of the trait anxiety scale which assesses general feeling and the state anxiety scale which assesses present feelings. Both scales are scored from 20-80, where lower scores indicate less anxiety.
The Spielberger State Trait Anxiety Inventory will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in Patient Health Questionnaire (PHQ-9)
The PHQ-9 consists of 9 items scoring depression. Each item is scored from 0-3, with total scores ranging from 0-27, and higher scores indicate greater depressive symptoms. The PHQ-9 will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in World Health Organization Quality of Life Instruments (WHOQOL-BREF)
The WHOQOL-BREF is used to assess physical and psychological health, social relationships and environment. It consists of 4 domains assessed from 0-100, where higher scores indicate greater quality of life. The WHOQOL-BREF will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in Revised Body Awareness Rating Questionnaire
The Revised Body Awareness Rating Questionnaire is a 12-item scale assessing how tension in the body affects one's body awareness and function in daily life. Each item is scored from 0-3, with total scores ranging from 0-36. Lower scores indicate better body awareness. The Revised Body Awareness Rating Questionnaire will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in Kinesthetic and Visual Imagery Questionnaire (KVIQ)
The KVIQ assesses a 5-point ordinal scale the clarity of the image (visual) and a 5-point ordinal scale of the intensity of the sensations (kinesthetic) that the subjects are able to imagine from the first-person perspective imagery. Each item is scored 1-5 and summed for a global score, higher scores indicating better imagery. KVIQ will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in Moorong Self-Efficacy Scale (MSES)
The MSES consists of 16 items each scored from 1-7, with total global scores ranging from 16-112. The MSES assesses self-efficacy related to everyday life activities and is designed specifically for people with SCI/D. Higher scores indicate greater self-efficacy. The MSES will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in Tampa Scale for Fear of Re-Injury
The Tampa Scale consists of 17 items each scored from 1-4 with global scores ranging from 17-68. Lower scores indicate greater fear of re-injury. The Tampa Scale will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Change in Patient-Specific Functional Scale
For the Patient-Specific Functional Scale, the participant reports on 3 activities that are important to the participant that they are unable to do because of their pain. Participants rate them between 0 (unable to do the activity) and 10 (able to do the activity). The scale assesses perceived disability in adults with chronic conditions.
The Patient-Specific Functional Scale will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
The Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF)
The CHART-SF assesses the degree by which a person with SCI/D remains with impairment or disability. It measures the type and level of assistance needed physically and cognitively; the level of physical activity; transportation needs; how time is spent; social interactions; and financial resources. Each of six domains is scored from 0-100, with total scores ranging from 0-600. Higher scores indicate less impairment. The CHART-SF will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Van de Winckel, PhD, MSPT, PT, Principal investigator, University of Minnesota Medical School Department of Rehabilitation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167032
- Sponsor's protocol ID
- PMR-2021-30498
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van de Winckel A, Carpentier ST, Bottale S, Blackwood J, Deng W, Zhang L, Hendrickson TJ, Mueller BA, Nourian R, Melander-Smith S, Morse LR, Lim KO. Greater sustained sensorimotor function recovery and neuropathic pain reduction with Cognitive Multisensory Rehabilitation compared to adaptive fitness in adults with spinal cord injury: a pilot clinical trial. medRxiv [Preprint]. 2026 Apr 1:2026.03.26.26349257. doi: 10.64898/2026.03.26.26349257.
PubMed 41959829
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05167032
- Acronym / sponsor ID
- PMR-2021-30498
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Multisensory Rehabilitation (CMR) Group | Experimental | Behavioral: Cognitive Multisensory Rehabilitation (CMR)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. |
| Adaptive Fitness Group | Active comparator | Behavioral: Adaptive fitnessAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Incomplete or complete SCI/D of ≥3 months
- Medically stable.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Multisensory Rehabilitation (CMR) Group |
| Adaptive fitnessThe 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. | Behavioural | Adaptive Fitness Group |
Primary outcome
Change in Brain Motor Control Assessment (BMCA)
Time frame: 3 Months
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.
Change in ISNCSCI Neurologic exam (ASIA test)
Time frame: 3 Months
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.
Change in Neuromuscular Recovery Scale (NRS)
Time frame: 3 Months
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.
Change in Spinal Cord Injury Functional Index/Assistive Technology (SCI-FI/AT)
Time frame: 3 Months
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.
Change in International Spinal Cord Injury Pain Basic Set Version 2.0 (SCI Pain Test) which includes the numerical pain rating scale
Time frame: 3 Months
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.
10 secondary outcomes
Change in Pittsburgh Sleep Quality Index
Time frame: 3 Months
Change in Spielberger State Trait Anxiety Inventory
Time frame: 3 Months
Change in Patient Health Questionnaire (PHQ-9)
Time frame: 3 Months
Change in World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Time frame: 3 Months
Change in Revised Body Awareness Rating Questionnaire
Time frame: 3 Months
Change in Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: 3 Months
Change in Moorong Self-Efficacy Scale (MSES)
Time frame: 3 Months
Change in Tampa Scale for Fear of Re-Injury
Time frame: 3 Months
Change in Patient-Specific Functional Scale
Time frame: 3 Months
The Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF)
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 41959829Van de Winckel A, Carpentier ST, Bottale S, Blackwood J, Deng W, Zhang L, Hendrickson TJ, Mueller BA, Nourian R, Melander-Smith S, Morse LR, Lim KO. Greater sustained sensorimotor function recovery and neuropathic pain reduction with Cognitive Multisensory Rehabilitation compared to adaptive fitness in adults with spinal cord injury: a pilot clinical trial. medRxiv [Preprint]. 2026 Apr 1:2026.03.26.26349257. doi: 10.64898/2026.03.26.26349257.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Van de Winckel, PhD, MSPT, PT principal investigator
University of Minnesota Medical School Department of Rehabilitation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Multisensory Rehabilitation (CMR) and Adaptive fitness in people with Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Motor Control Assessment (BMCA) (time frame: 3 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.