Reciprocal Inhibition Versus Reciprocal Facilitation In Spinal Cord Injury Patients

August 11, 2023 updated by: Mustafa Kökçe, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Does Reciprocal Inhibition, a Rehabilitation Technique, Convert to Reciprocal Facilitation in Patients With Upper Motor Neuron Lesions?

Reciprocal inhibition is a medulla spinalis control mechanism that facilitates motor activities in healthy people. As the agonist muscle contracts, the antagonist muscle is inhibited so that the agonist action can take place properly. In the literature, there are studies showing that in patients with upper motor neuron lesions, this reverses, and reciprocal facilitation occurs instead of inhibition. However, there is no clear situation in this regard, there is a need for more methodologically sound studies. Our aim in this study is to investigate the presence of reciprocal facilitation in patients with spinal cord lesions (SCL).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Reciprocal inhibition is a spinal segmental control mechanism that facilitates motor activities in healthy people and is also used in treating spasticity. Considering the current literature, there are some studies claiming that this is reversed in patients with upper motor neuron lesions and that there is reciprocal facilitation instead of inhibition. However, the proposed evidence is not convincing. Our aim in this study was to investigate the presence of reciprocal facilitation in detail in patients with upper motor neuron lesions. This study was conducted in five patients with spinal cord lesions and five healthy individuals. Both the tibialis anterior and soleus muscles of the cases were recorded using surface and multi-motor unit electromyography (EMG) electrodes. To elicit an H reflex in the soleus muscle, an electric current was delivered through the popliteal fossa using the monopolar technique. The Achilles tendon was tapped with the reflex hammer to elicit a T reflex. Since the H-reflex and T-reflex responses were detected in the tibialis anterior muscle surface and multi-motor unit EMG recordings, the findings were evaluated as direct stimulation, cross-talk, and reciprocal facilitation. Methodologically, This research aimed to be a guiding study for future studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34180
        • İstanbul Physical Therapy Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with spinal cord injury between the ages of 18-60
  • A minimum of 6 months of SCL history
  • Soleus spasticity

Exclusion Criteria:

  • Patients with premorbid neuromuscular disease
  • History of autonomic dysreflexia
  • Patients in the spinal shock period
  • Those who have a coronavirus disease clinic
  • Less than 2 hours sitting tolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spinal cord injuries
This was the patient group. Achilles tendon hits were performed for eliciting the soleus T reflex while the ankle was in neutral, dorsiflexion, and plantar flexion. Surface and multi-unit EMG recordings were taken from the anterior and soles muscles of the tibialis during the tendon tapping.
Diagnostic test: Tendon tap
While examining the T reflex, the ankle was held passively in neutral, dorsiflexion and plantar flexion positions by the investigator.
Other Names:
  • T-reflex
Diagnostic test: Tibial nerve stimulation
H-reflex responses were examined by tibial nerve stimulation
Other Names:
  • H-reflex
Active Comparator: Healthy Control
This was the healthy control group. Achilles tendon hits were performed for eliciting the soleus T reflex while the ankle was in neutral, dorsiflexion, and plantar flexion. Surface and multi-unit EMG recordings were taken from the anterior and soles muscles of the tibialis during the tendon tapping.
Diagnostic test: Tendon tap
While examining the T reflex, the ankle was held passively in neutral, dorsiflexion and plantar flexion positions by the investigator.
Other Names:
  • T-reflex
Diagnostic test: Tibial nerve stimulation
H-reflex responses were examined by tibial nerve stimulation
Other Names:
  • H-reflex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reciprocal Inhibition
Time Frame: up to 2 weeks
H reflex and T reflex tests were performed in the soleus and tibialis anterior muscle, and it was evaluated whether there was reciprocal inhibition in the tibialis anterior muscle.
up to 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
H-reflex
Time Frame: up to 2 weeks
Electric current was delivered through the popliteal fossa to tibial nerve for eliciting the soleus H-reflex
up to 2 weeks
T-reflex
Time Frame: up to 2 weeks
The Achilles tendon was hit with using a reflex hammer to elicit the soleus T-reflex.
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: İLHAN KARACAN, MD, Prof, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIVRFSCIP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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