Health Trialsby

Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning

ConditionsSpinal Cord Injuries Neurological Injury Paralysis Spasticity, Muscle

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedical University of South Carolina

About this trial

The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a clinically stable spinal cord injury (above T11) that occurred at least one year previously

the ability to ambulate at least 10 m with or without an assistive device (i.e., walker, crutches, or cane, not parallel bars) within 100 sec (those with 10-meter walking time >100 sec are excluded because it is unlikely that they are able to participate in and complete our planned locomotion evaluation procedures)

clinical signs of spasticity in the plantarflexor muscles at least unilaterally (i.e., hyperreactivity to Achilles tendon tap, and increased muscle tone, score >1 on Modified Ashworth scale)

spastic hyperreflexia reflected in exaggerated H-reflex

Disqualifiers

motoneuron injury;

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

an unstable medical condition

a pre-existing or confounding neurological condition (e.g., history of Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), Stroke, Parkinson's disease)

Trial design

Design model

Single group

Treatments tested in this trial

Spinal Reflex Operant Down Conditioning
Behavioral
This is a training intervention in which people with a spinal cord injury are trained to reduce the activity of a certain spinal reflex. By decreasing this reflex, individuals decrease hyperactivity in the reflex and can reduce spasticity.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Validation of the new training systemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity

Time frame

Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

2

Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)

Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)

Time frame

Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

3

Change in walking distance (meters) as measured by the 6-minute walk test

The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.

Time frame

Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

Secondary outcomes

1

Change in the level of assistance required to walk 10 meters as measured by the Walking Index for Spinal Cord Injury (WI-SCI)

WI-SCI classifies the level of assistance needed to perform the 10MWT; the scale is from 0-20 with 20 being no assistance required at all. An increase of score indicates increased level of independence while walking.

Time frame

Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

2

Change in level of spasticity in the more affected leg as measured by the Modified Ashworth Scale (MAS)

A decrease in the score on the MAS indicates a decrease in spasticity. To measure spasticity, resistance to passive movement about a joint is tested at a range of velocities. The score ranges from 0-4 (i.e., 0: normal muscle tone; 4: rigid in flexion or extension).

Time frame

Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

3

Change in balance as measured by Berg Balance Scale

An increase in score on the Berg Balance scale indicates better balance and decreased fall risk. For each item, the score ranges from 0-4 with a maximum total score of 56.

Time frame

Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

4

Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)

An increase in the the score on the SCIM III indicates increased basic functional independence. This is a self report questionnaire with 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, subscore 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100.

Time frame

Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov