NCT05985031

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

12 days

First QC Date

August 2, 2023

Last Update Submit

August 11, 2023

Conditions

Keywords

Spinal Cordmotor neuronSpasticity

Outcome Measures

Primary Outcomes (1)

  • Reciprocal Inhibition

    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 Outcomes (2)

  • H-reflex

    up to 2 weeks

  • T-reflex

    up to 2 weeks

Study Arms (2)

Spinal cord injuries

EXPERIMENTAL

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 tapDiagnostic Test: Tibial nerve stimulation

Healthy Control

ACTIVE COMPARATOR

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 tapDiagnostic Test: Tibial nerve stimulation

Interventions

Tendon tapDIAGNOSTIC_TEST

While examining the T reflex, the ankle was held passively in neutral, dorsiflexion and plantar flexion positions by the investigator.

Also known as: T-reflex
Healthy ControlSpinal cord injuries

H-reflex responses were examined by tibial nerve stimulation

Also known as: H-reflex
Healthy ControlSpinal cord injuries

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Physical Therapy Training and Research Hospital

Istanbul, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord InjuriesMuscle Spasticity

Interventions

H-Reflex

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reflex, MonosynapticReflexNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • İLHAN KARACAN, MD, Prof

    İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Group I. Spinal cord injuries Group II. Healthy Control
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant doctor

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

January 5, 2023

Primary Completion

January 17, 2023

Study Completion

August 1, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations