NCT04005937

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 30, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

17 days

First QC Date

June 30, 2019

Last Update Submit

July 21, 2019

Conditions

Muscle HypertoniaReflex, Abnormal

Keywords

muscle spindleH reflexspasticity

Outcome Measures

Primary Outcomes (1)

  • H-reflex suppression

    Change in H-reflex amplitude throughout consecutive stimuli

    1 day

Study Arms (1)

H-reflex

EXPERIMENTAL

H-reflex with different interstimulus interval of the plegic side soleus muscle were tested

Diagnostic Test: H-reflex

Interventions

H-reflexDIAGNOSTIC_TEST

Electrical stimulation of Group Ia afferent of muscle spindle

H-reflex

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cerebrovascular stroke
  • Both sex

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

stanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Bahçelievler, 34186, Turkey (Türkiye)

Location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle HypertoniaReflex, AbnormalMuscle Spasticity

Interventions

H-Reflex

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Reflex, MonosynapticReflexNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dilara Ekici, MD

    stanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Effects of spasticity on consecutive H-reflex response in patients with hemiplegia
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 2, 2019

Study Start

June 30, 2019

Primary Completion

July 17, 2019

Study Completion

July 17, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)