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Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005937
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief Summary:
This study evaluates the optimal interstimulus interval for consecutive H-reflex responses in patients with spasticity.

Condition or disease Intervention/treatment Phase
Muscle Hypertonia Reflex, Abnormal Diagnostic Test: H-reflex Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Effects of spasticity on consecutive H-reflex response in patients with hemiplegia
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity
Actual Study Start Date : June 30, 2019
Actual Primary Completion Date : July 17, 2019
Actual Study Completion Date : July 17, 2019

Arm Intervention/treatment
Experimental: H-reflex
H-reflex with different interstimulus interval of the plegic side soleus muscle were tested
Diagnostic Test: H-reflex
Electrical stimulation of Group Ia afferent of muscle spindle




Primary Outcome Measures :
  1. H-reflex suppression [ Time Frame: 1 day ]
    Change in H-reflex amplitude throughout consecutive stimuli



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cerebrovascular stroke
  • Both sex

Exclusion Criteria:

  • 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
  • Botulinum toxin injection within last 12 weeks
  • Anxiety
  • Patients with pain on test day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005937


Locations
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Turkey
stanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Bahçelievler, Turkey, 34186
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
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Principal Investigator: Dilara Ekici, MD stanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul
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Responsible Party: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04005937    
Other Study ID Numbers: IstPMRTRH
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital:
muscle spindle
H reflex
spasticity
Additional relevant MeSH terms:
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Muscle Spasticity
Muscle Hypertonia
Reflex, Abnormal
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms