Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity
Primary Purpose
Muscle Hypertonia, Reflex, Abnormal
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
H-reflex
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Hypertonia focused on measuring muscle spindle, H reflex, spasticity
Eligibility 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
Sites / Locations
- stanbul Physical Medicine Rehabilitation Training and Research Hospital
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
H-reflex
Arm Description
H-reflex with different interstimulus interval of the plegic side soleus muscle were tested
Outcomes
Primary Outcome Measures
H-reflex suppression
Change in H-reflex amplitude throughout consecutive stimuli
Secondary Outcome Measures
Full Information
NCT ID
NCT04005937
First Posted
June 30, 2019
Last Updated
July 21, 2019
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04005937
Brief Title
Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity
Official Title
Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Hypertonia, Reflex, Abnormal
Keywords
muscle spindle, H reflex, spasticity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Effects of spasticity on consecutive H-reflex response in patients with hemiplegia
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H-reflex
Arm Type
Experimental
Arm Description
H-reflex with different interstimulus interval of the plegic side soleus muscle were tested
Intervention Type
Diagnostic Test
Intervention Name(s)
H-reflex
Intervention Description
Electrical stimulation of Group Ia afferent of muscle spindle
Primary Outcome Measure Information:
Title
H-reflex suppression
Description
Change in H-reflex amplitude throughout consecutive stimuli
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilara Ekici, MD
Organizational Affiliation
stanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul
Official's Role
Principal Investigator
Facility Information:
Facility Name
stanbul Physical Medicine Rehabilitation Training and Research Hospital
City
Istanbul
State/Province
Bahçelievler
ZIP/Postal Code
34186
Country
Turkey
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimal Interstimulus Interval For Consecutive H-Reflex Responses In Patients With Spasticity
We'll reach out to this number within 24 hrs