All > Spinal Cord Injury

Spinal Reflex Operant Down Conditioning for Paralysis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SCParalysis+3 MoreSpinal Reflex Operant Down Conditioning - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a reflex training system can change the size of a reflex in people with chronic incomplete SCI. 25 participants are needed, and the study will last for 6 months with 45 visits.

Eligible Conditions
  • Paralysis
  • Spinal Cord Injury
  • Spasticity
  • Neurotrauma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

Month 3
Change in balance as measured by Berg Balance Scale
Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
Change in dynamic and static muscle length and joint range of motion (ROM) as measured by Tardieu Scale
Change in functional independence as measured by the Functional Independence Measure (FIM)
Change in level of spasticity in the more affected leg as measured by the Modified Ashworth Scale (MAS)
Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation
Change in the level of assistance required to walk 10 meters as measured by the Walking Index for Spinal Cord Injury (WI-SCI)
Change in walking distance (meters) as measured by the 6-minute walk test
Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)
Change is strength of key muscles in the lower extremity as measured by Manual Muscle Testing (MMT)

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Validation of the new training system
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Spinal Reflex Operant Down Conditioning · No Placebo Group · N/A

Validation of the new training system
Behavioral
Experimental Group · 1 Intervention: Spinal Reflex Operant Down Conditioning · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
855 Previous Clinical Trials
5,390,184 Total Patients Enrolled
2 Trials studying Paralysis
60 Patients Enrolled for Paralysis
Aiko Thompson, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
15 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a spinal cord injury that is not expected to worsen and happened at least one year ago, and it is located above the T11 vertebra.
References

Frequently Asked Questions

Is enrollment for this investigation actively open?

"The information on clinicialtrials.gov reveals that patient recruitment for this particular trial has been paused since May 11th 2022, when it was last updated. Although no more participants are being accepted now, over one thousand other studies remain open to new enrollees." - Anonymous Online Contributor

Unverified Answer

What objectives is this clinical experiment attempting to fulfill?

"The primary outcome of this investigation is the alteration in walking speed (m/s) as determined by the 10-meter Walk Test (10MWT), assessed at baseline, after conclusion of intervention sessions (~10 weeks), 1 month and 3 months post-intervention. Secondary outcomes include change in spasticity level on the Modified Ashworth Scale (MAS; 0 to 4 scale where a lower score indicates reduced spasticity); balance improvement measured through Berg Balance Scale (0 to 56 scale with increasing scores signifying better equilibrium and decreased risk of falls); together with variation in basic functional independence per Spinal Cord Independence Measure III (SCIM" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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