Spinal Cord InjuriesNCT05985031
Reciprocal Inhibition Versus Reciprocal Facilitation In Spinal Cord Injury Patients
A study testing Tendon tap and Tibial nerve stimulation in people with Spinal Cord Injuries, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Tendon tap and Tibial nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with spinal cord injury between the ages of 18-60
- A minimum of 6 months of SCL history
- Soleus spasticity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Physical Therapy Training and Research Hospital
Istanbul, 34180
About this study
Official title: 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).
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Tendon tap, Tibial nerve stimulation
- Keywords
- Spinal Cord, motor neuron, Spasticity
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon tapDiagnostic test
Also called T-reflex
While examining the T reflex, the ankle was held passively in neutral, dorsiflexion and plantar flexion positions by the investigator.
Tibial nerve stimulationDiagnostic test
Also called H-reflex
H-reflex responses were examined by tibial nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Tendon tap; Diagnostic 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. Receives: Diagnostic Test: Tendon tap; Diagnostic Test: Tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 weeks
Secondary outcomes (2)
H-reflex
Electric current was delivered through the popliteal fossa to tibial nerve for eliciting the soleus H-reflex
Measured: up to 2 weeks
T-reflex
The Achilles tendon was hit with using a reflex hammer to elicit the soleus T-reflex.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start5 Jan 2023
- Primary completion17 Jan 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group I. Spinal cord injuries Group II. Healthy Control
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Kökçe, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- İLHAN KARACAN, MD, Prof, Study director, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985031
- Sponsor's protocol ID
- RIVRFSCIP
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Reciprocal Inhibition, a Rehabilitation Technique, Convert to Reciprocal Facilitation in Patients With Upper Motor Neuron Lesions?
- ClinicalTrials.gov ID
- NCT05985031
- Acronym / sponsor ID
- RIVRFSCIP
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord, motor neuron, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group I. Spinal cord injuries Group II. Healthy Control
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injuries | Experimental | Diagnostic Test: Tendon tap, Diagnostic Test: Tibial nerve stimulationThis 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. |
| Healthy Control | Active comparator | Diagnostic Test: Tendon tap, Diagnostic Test: Tibial nerve stimulationThis 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with spinal cord injury between the ages of 18-60
- A minimum of 6 months of SCL history
- Soleus spasticity
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendon tapAlso: T-reflexWhile examining the T reflex, the ankle was held passively in neutral, dorsiflexion and plantar flexion positions by the investigator. | Diagnostic test | Healthy Control, Spinal cord injuries |
| Tibial nerve stimulationAlso: H-reflexH-reflex responses were examined by tibial nerve stimulation | Diagnostic test | Healthy Control, Spinal cord injuries |
Primary outcome
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.
2 secondary outcomes
H-reflex
Time frame: up to 2 weeks
T-reflex
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İLHAN KARACAN, MD, Prof study director
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendon tap and Tibial nerve stimulation in people with Spinal Cord Injuries, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reciprocal Inhibition (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.