Behavioral Intervention

Reflex Training for Spinal Cord Injury

Charleston, SC

N/A

Recruiting

Led By Aiko Thompson, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical signs of spasticity in the plantarflexor muscles at least unilaterally

Functionally and medically stable for at least 3 months

Must not have

Cardiac condition (history of myocardial infarct, pacemaker use, etc.)

Condition that prevents lower extremity mobility testing or weight bearing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

Awards & highlights

No Placebo-Only Group

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.

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Who is the study for?

This trial is for individuals with chronic incomplete spinal cord injury who can walk at least 10 meters, have leg spasticity, and are medically stable. They must be able to consent and not expect medication changes during the study. Excluded are those with unstable health, cognitive impairments, other neurological conditions, daily use of certain electrical stimulation devices, motoneuron injuries, serious heart issues, inability to test lower limb mobility or weight bearing, recent deep vein thrombosis or pregnancy.Check my eligibility

What is being tested?

The trial tests a reflex training system designed to reduce the size of targeted muscle reflexes in people with spinal cord injuries. Participants will undergo about 45 sessions over six months to see if this method can help manage spasticity in their legs by conditioning their spinal reflexes.See study design

What are the potential side effects?

While specific side effects aren't listed for this type of non-drug intervention, participants might experience discomfort or fatigue from repeated testing sessions. There may also be potential risks associated with any physical therapy-like activities such as muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have muscle stiffness in at least one of my lower legs.

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I have been medically stable without major changes for the last 3 months.

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I can walk 10 meters in 100 seconds, with or without help.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart issues, like a heart attack or use a pacemaker.

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I cannot perform tests that require walking or standing.

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I use an FES device for foot-drop or exercise daily.

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I have a motor neuron injury.

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I do not have a history of MS, TBI, stroke, or Parkinson's disease.

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I am able to understand and consent to medical procedures.

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I have a health condition that changes rapidly.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation

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)

Secondary study objectives

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

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Validation of the new training systemExperimental Treatment1 Intervention

The researchers will measure changes in H-reflex size achieved with the use of the new system and compare these measures with the existing results in 25 spastic individuals with chronic incomplete SCI. Each participant completes 6 baseline sessions and 30 conditioning sessions. In the 30 conditioning sessions, the soleus H-reflex will be down-conditioned to decrease the activity of the hyperactive spinal stretch reflex pathway in people with spasticity that is characterized by exaggerated reflex activity. It is anticipated that the magnitude of reflex change obtained with the use of the new system would be greater or at least the same as the bench-marked values from the previous studies that used the old prototype reflex conditioning system.

0 / 10Eligibility criteria met