Muscle HypertoniaNCT04005937
Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity
A study testing H-reflex in people with Muscle Hypertonia and Reflex, Abnormal, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study evaluates the optimal interstimulus interval for consecutive H-reflex responses in patients with spasticity. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Hypertonia, Reflex, Abnormal
- What is being tested?
- H-reflex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Jun 2019to 17 Jul 2019
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cerebrovascular stroke
- Both sex
Who cannot join
- Duration after stroke is less than 20 days
- Lesions in calf skin
- Excessive spasticity (Ashworth 4) / Contracture (foot joint)
- Absent of soleus spasticity
- Peripheral nerve diseases / muscle diseases
- Absent of H-reflex
Show all 9Show fewer
- Botulinum toxin injection within last 12 weeks
- Anxiety
- Patients with pain on test day
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
stanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Bahçelievler, 34186
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
This study evaluates the optimal interstimulus interval for consecutive H-reflex responses in patients with spasticity.
Read the detailed description
This study will include 15 patients with spastic stroke patients H-reflex with different interstimulus interval of the plegic side soleus muscle will be tested.
Subjects lay comfortably in the supine position on an examination bed. The subject will be asked not to contract the lower extremity muscles during the experiment. Surface EMG (SEMG) will be recorded from the plegic side soleus muscle using bipolar electrodes. These electrodes will be placed on the soleus muscle according to the SENIAM guideline.The reference electrode will be placed on medial malleolus. Prior to electrode placement, the skin will be shaved, lightly abraded, and cleaned with alcohol wipes. Self-adhesive, disposable, Ag-AgCl disc electrodes with a disc radius of 10 mm (KENDALL® Arbo; Coviden; Massachusetts, USA) will be used. To prevent the sway of electrode cables, it will be fixed to the body. SEMG and stimulator data will be obtained by using a data acquisition system (POWERLAB® ADInstruments Co, Oxford, United Kingdom). Sampling rate will be 10 kHz.
The recorded data will be processed and analyzed offline using LabChart7® Software Version V7.3.3 (PowerLab® system ADInstruments, Oxford, United Kingdom).
A cathode (5×5 mm) will be placed at the midpoint of popliteal fossa and an anode (10×10 cm) will be placed immediately proximal to the patella to evoke the H-reflex for monopolar stimulation of the posterior tibial nerve. A monophasic electrical current will be delivered as square pulses with a width of 1 ms by using a stimulator (FE155 Stimulator HC ADInstrument, Oxford UK). Taking into consideration study of Ozyurt et al, interstimulus interval will be selected as 10 seconds for determining the maximum H-reflex (Hmax). Then, Hmax and M-response (Mmax) will be determined.
We will be tested four different ISI (10s, 5s, 3s and 1s) for stroke patients in this study. The stimulus intensity for tested H-reflex will be selected as a constant stimulus strength that will be 50 percent of the Hmax.
Thirty consecutive stimuli will be delivered in separate sets for each tested ISI of 10, 5, 3 and 1s. The ISI sets will be tested in random order to negate any order effect. There will be a 15s of interval between sets.
SEMG recordings will be filtered using a bandpass filter from 5 to 500 Hz. Then the peak-to-peak (P-P) amplitudes of H-reflex will be measured then normalized using by two different methods to estimate H-reflex suppression due to consecutive stimuli. In the first method, P-P amplitude of the first H-reflex response will be used as a control, and P-P amplitude of the second H-reflex response will be normalized by using the control for each ISI set. Thus, HPP2 / HPP1 ratio will be calculated. Similar to the previous method, the first H-reflex response will be used as the control in the second method. Unlike the first method, not only the second H-reflex response, but the remaining 29 H-responses will be normalized to the first H-response. P-P amplitude of the 29 normalized H-reflex responses will be averaged and HPP29/HPP1 ratio will be calculated.
The peak-to-peak amplitude of the first H-reflex response will be measured then normalized to the Mmax (HPP1/Mmax) to compare H-reflexes between subjects and conditions.
- Conditions
- Muscle Hypertonia, Reflex, Abnormal
- Being tested
- H-reflex
- Keywords
- muscle spindle, H reflex, spasticity
- Medical subject headings
- Muscle Hypertonia, Reflex, Abnormal, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-reflexDiagnostic test
Electrical stimulation of Group Ia afferent of muscle spindle
| Study group | Role | What they receive |
|---|---|---|
| H-reflex | Experimental | H-reflex with different interstimulus interval of the plegic side soleus muscle were tested Receives: Diagnostic Test: H-reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex suppression
Change in H-reflex amplitude throughout consecutive stimuli
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start30 Jun 2019
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle HypertoniaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Effects of spasticity on consecutive H-reflex response in patients with hemiplegia
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dilara Ekici, MD, Principal investigator, stanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005937
- Sponsor's protocol ID
- IstPMRTRH
- Status last verified
- Jul 2019
- First submitted
- 30 Jun 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity
- ClinicalTrials.gov ID
- NCT04005937
- Acronym / sponsor ID
- IstPMRTRH
- Conditions
- Muscle Hypertonia, Reflex, Abnormal
- Keywords
- muscle spindle, H reflex, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 2 Jul 2019 (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.
This study evaluates the optimal interstimulus interval for consecutive H-reflex responses in patients with spasticity.
Detailed description
This study will include 15 patients with spastic stroke patients H-reflex with different interstimulus interval of the plegic side soleus muscle will be tested.
Subjects lay comfortably in the supine position on an examination bed. The subject will be asked not to contract the lower extremity muscles during the experiment. Surface EMG (SEMG) will be recorded from the plegic side soleus muscle using bipolar electrodes. These electrodes will be placed on the soleus muscle according to the SENIAM guideline.The reference electrode will be placed on medial malleolus. Prior to electrode placement, the skin will be shaved, lightly abraded, and cleaned with alcohol wipes. Self-adhesive, disposable, Ag-AgCl disc electrodes with a disc radius of 10 mm (KENDALL® Arbo; Coviden; Massachusetts, USA) will be used. To prevent the sway of electrode cables, it will be fixed to the body. SEMG and stimulator data will be obtained by using a data acquisition system (POWERLAB® ADInstruments Co, Oxford, United Kingdom). Sampling rate will be 10 kHz.
The recorded data will be processed and analyzed offline using LabChart7® Software Version V7.3.3 (PowerLab® system ADInstruments, Oxford, United Kingdom).
A cathode (5×5 mm) will be placed at the midpoint of popliteal fossa and an anode (10×10 cm) will be placed immediately proximal to the patella to evoke the H-reflex for monopolar stimulation of the posterior tibial nerve. A monophasic electrical current will be delivered as square pulses with a width of 1 ms by using a stimulator (FE155 Stimulator HC ADInstrument, Oxford UK). Taking into consideration study of Ozyurt et al, interstimulus interval will be selected as 10 seconds for determining the maximum H-reflex (Hmax). Then, Hmax and M-response (Mmax) will be determined.
We will be tested four different ISI (10s, 5s, 3s and 1s) for stroke patients in this study. The stimulus intensity for tested H-reflex will be selected as a constant stimulus strength that will be 50 percent of the Hmax.
Thirty consecutive stimuli will be delivered in separate sets for each tested ISI of 10, 5, 3 and 1s. The ISI sets will be tested in random order to negate any order effect. There will be a 15s of interval between sets.
SEMG recordings will be filtered using a bandpass filter from 5 to 500 Hz. Then the peak-to-peak (P-P) amplitudes of H-reflex will be measured then normalized using by two different methods to estimate H-reflex suppression due to consecutive stimuli. In the first method, P-P amplitude of the first H-reflex response will be used as a control, and P-P amplitude of the second H-reflex response will be normalized by using the control for each ISI set. Thus, HPP2 / HPP1 ratio will be calculated. Similar to the previous method, the first H-reflex response will be used as the control in the second method. Unlike the first method, not only the second H-reflex response, but the remaining 29 H-responses will be normalized to the first H-response. P-P amplitude of the 29 normalized H-reflex responses will be averaged and HPP29/HPP1 ratio will be calculated.
The peak-to-peak amplitude of the first H-reflex response will be measured then normalized to the Mmax (HPP1/Mmax) to compare H-reflexes between subjects and conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Effects of spasticity on consecutive H-reflex response in patients with hemiplegia
| Arm | Type | Receives |
|---|---|---|
| H-reflex | Experimental | Diagnostic Test: H-reflexH-reflex with different interstimulus interval of the plegic side soleus muscle were tested |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cerebrovascular stroke
- Both sex
Key exclusion criteria (9 listed)
- Duration after stroke is less than 20 days
- Lesions in calf skin
- Excessive spasticity (Ashworth 4) / Contracture (foot joint)
- Absent of soleus spasticity
- Peripheral nerve diseases / muscle diseases
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 |
|---|---|---|
| H-reflexElectrical stimulation of Group Ia afferent of muscle spindle | Diagnostic test | H-reflex |
Primary outcome
H-reflex suppression
Time frame: 1 day
Change in H-reflex amplitude throughout consecutive stimuli
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 23 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Dilara Ekici, MD principal investigator
stanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H-reflex in people with Muscle Hypertonia and Reflex, Abnormal, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites 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 2 inclusion and 9 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
H-reflex suppression (time frame: 1 day). 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 23 Jul 2019.