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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05513781
Other study ID # E-59394181-604.01.02-39134
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 20, 2022
Est. completion date November 15, 2023

Study information

Verified date February 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, it is aimed to examine the factors that cause knee hyperextension in chronic stroke patients. Although the presence of weakness or spasticity in the quadriceps muscle, weakness or spasticity in the plantar flexors, and weakness of the dorsiflexors, hamstrings and gastrocnemius muscle are shown in the literature as the cause of hyperextension of the affected knee in hemiplegic patients, there is a comprehensive study that shows the effect of both muscle strength and spasticity in the lower extremity muscles. there are no studies. The hypotheses of the study are: Hypothesis 1: H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients. H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients. Hypothesis 2; H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients. H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients. Hypothesis 3; H0: There is no relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients. H1: There is a relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date November 15, 2023
Est. primary completion date October 11, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - Being between the ages of 40-65 - At least 6 months have passed since the stroke - Ambulation with or without a walking aid (walker, cane, or tripod) - Being between 0-3 points according to the Modified Rankin Score - Getting a score of 24 or higher on the Mini Mental Test - Presence of hyperextension in the stance phase of gait - Volunteering to participate in the study Exclusion Criteria: - Having a history of more than one stroke - Known presence of dementia - Having a known orthopedic, psychiatric or other neurological disease - Having a situation that prevents communication - Having a history of surgery involving lower extremities and gait

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe University Altindag Ankara

Sponsors (2)

Lead Sponsor Collaborator
Hacettepe University Atilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Cooper A, Alghamdi GA, Alghamdi MA, Altowaijri A, Richardson S. The relationship of lower limb muscle strength and knee joint hyperextension during the stance phase of gait in hemiparetic stroke patients. Physiother Res Int. 2012 Sep;17(3):150-6. doi: 10.1002/pri.528. Epub 2011 Dec 7. — View Citation

Moseley A, Wales A, Herbert R, Schurr K, Moore S. Observation and analysis of hemiplegic gait: stance phase. Aust J Physiother. 1993;39(4):259-67. doi: 10.1016/S0004-9514(14)60486-4. — View Citation

Roth EJ, Merbitz C, Mroczek K, Dugan SA, Suh WW. Hemiplegic gait. Relationships between walking speed and other temporal parameters. Am J Phys Med Rehabil. 1997 Mar-Apr;76(2):128-33. doi: 10.1097/00002060-199703000-00008. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Movement Analysis Reflective signs will be placed at certain anatomical points of the participants. Participants will be asked to walk a distance of 5 meters. The three-dimensional positions of these reflective marks will be recorded with the 8-camera Vicon motion capture system. Then it will be examined in computer environment using Blade software. Baseline
Primary Electromyographic Measurements Electromyography (EMG) is frequently used in the literature for motion analysis evaluations. It shows the amplitude of the electrical activity of the muscles. In this study, 8-channel Delsys Bagnoli desktop cable electromyography system (Delsys (Delsys Inc., USA)) will be used. EMG; It shows whether the muscles are active during movement, when they are active and how active they are. In this study, the muscles to be measured by EMG: tibialis anterior, medial gastrocnemius, medial hamstrings, rectus femoris, gluteus medius and the lower part of the latismus dorsi are planned. Baseline
Secondary Muscle Strength Evaluation Manual muscle testing will be performed on patients' hip flexors, hip extensors, hip abductors, hip adductors, knee flexors, knee extensors, dorsiflexors, and plantar flexors. A score between 0 and 5 will be given according to the manual muscle test, the ability of the muscles to move against gravity in certain positions, and the resistance of the movement against gravity. Baseline
Secondary Spasticity Evaluation The spasticity of the lower extremity muscles (quadriceps, hip extensors, hip adductors, hip internal retractors and plantar flexors) will be evaluated according to the Modified Ashworth Scale. The spasticity assessment will be scored between 0 and 4 according to the resistance of the muscles to passive movement. Baseline
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