Stroke Clinical Trial
Official title:
The Comparison of the Effects of PNF and Static Stretching Applied to the Elbow Flexors on Muscle Architecture and Viscoelastic Properties In Individuals With Chronic Stroke
Verified date | February 2024 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The patients who were diagnosed with stroke in governmental/university/private hospitals, and who needed rehabilitation because of the increased flexor tone in the elbow joint, decreased range of motion and/or decreased function of the upper extremity will be invited to the study in accordance with the criteria that are given in inclusion and exclusion part. Participants will be randomly assigned to one of two parallel groups, either the PNF Stretching Group (n=17) or the Prolonged Stretching Group (n=17), according to the order of participation in the study by simple randomization. An online computer program will be used to assign participants (https://www.randomizer.org/). Exercises that will increase proximal stabilization and control will be applied to both groups for 4 weeks, 5 days a week. In addition to the exercises, prolonged stretches for 10 minutes will be applied to the Prolonged Stretching Group, and PNF stretching will be applied to the PNF Stretching Group. At the beginning and the end of the study, muscle architecture, muscular viscoelastic properties, range of motion, proprioception, upper extremity motor performance and function and posture will be evaluated.
Status | Active, not recruiting |
Enrollment | 38 |
Est. completion date | April 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Stroke diagnosed by magnetic resonance imaging or computed tomography, regardless of ischemic or hemorrhagic origin; - Hemiplegia caused only by stroke; - At least 3 months have passed since the diagnosis of stroke; - At least 1+ spasticity according to Modified Ashworth Scale in the elbow flexors of the affected side; - Ability to maintain sitting balance for at least 20 seconds without support; - Being older than 18 years old; - Being voluntary to participate in the study. Exclusion Criteria: - Having a history of multiple strokes or bilateral involvement; - Botox application to any/all of the Biceps, Brachialis or Brachioradialis muscles within the last 6 months; - Changes in pharmacological treatment in the last 6 months; - Muscle involvement on the affected side that completely prevents the elbow joint range of motion; - Presence of conditions that may affect the level of spasticity (infection, febrile illness, etc.) - Mini Mental State Assessment Test score below 24; - Presence of neurological diagnosis other than stroke; - Insufficient vision, hearing and/or understanding ability to administer assessments and treatments. |
Country | Name | City | State |
---|---|---|---|
Turkey | ISÜFIZYOTEM (Istinye University Physiotherapy and Rehabilitation Application and Research Center) | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle architecture | The Epiq Elite Ultrasound System (Philips, Bothell, WA, USA) will be used to evaluate the muscle architecture (muscle thickness-MT, pennation angle-PA, fascicle length-FL and echogenicity-EG) of the elbow flexors (Biceps Brachii, Brachioradialis, Brachialis). We expect to observe a decrease in MT, PA, EG and increase in FL. Measurements will be taken in the supine position both in the relaxed position of the muscles with the elbow flexed to 90 degrees, the forearm and wrist supported in the neutral position, and after waiting for 30 seconds in the maximum extension position allowed by the elbow joint range of motion. Measurements will be taken 1 cm proximal to the cubital line for the Brachialis muscle, one-third of the distance between the cubital fossa and the acromion for the Biceps brachii muscle, and one-third of the distance between the lateral epicondyle of the humerus and the ulnar styloid process for the Brachioradialis muscle. The same radiologist will make measurements. | 1 month | |
Primary | Muscle viscoelastic properties | Myoton®PRO Digital Palpation Device (Myoton AS, Tallinn, Estonia) will be used to measure biceps brachii and Brachioradialis muscle tone, stiffness and elasticity. Measurements will be made at the most bulging points of the Biceps Brachii and Brachioradialis muscles and repeated 3 times. Measurements will be taken at rest, during maximum voluntary contraction, stretching and active reaching. We expect to observe a decrease in tone (decreased F value) and stiffness (decreased S value), and increase in elasticity (decreased D value). | 1 month | |
Secondary | Range of Motion | Passive elbow flexion and extension range of motion of the participants will be measured with Baseline Digital Absolute+Axis Goniometer in supine position. The pivot point will be placed on the lateral epicondyle of the humerus, the fixed arm will be placed so that the lateral midpoint of the humerus will follow the acromion, and the movable arm will be placed on the lateral midpoint of the forearm, following the radial styloid process. Measurement results will be recorded in degrees | 1 month | |
Secondary | Proprioception | Joint Position Reproduction Test at 60 degrees (narrow-angle) and 100 degrees (wide angle) will be used to measure the elbow proprioception of the participants. At the beginning of the test, the participants will be positioned in a sitting position, with the arm by the side of the body, the elbow at 20 degrees, and the eyes closed. In order to teach the target angles (60 and 100), the participants will be asked to actively bend the elbow to the target angle shown by the therapist and keep the position for 5 seconds. Then the test will be started. Patients will be asked to actively find the previously taught angle from starting position (20 degrees). The position that the participant stop will be measured by Baseline Digital Absolute+Axis Goniometer. The degree of deviation from the target angle will be recorded as the outcome measure. The test will be repeated 5 times. Between each active contraction, a 2-minute rest period will be given to prevent muscle fatigue. | 1 month | |
Secondary | Upper extremity motor performance | The Square Drawing Test will be used to evaluate the upper extremity motor performance of the participants. Participants will sit in a height-adjustable chair placed in front of the table which is approximately 30 cm below shoulder level. There will be a paper on the table and a template will be drawn on that paper. The template consisted of two concentric squares with side lengths of 19 cm and 21 cm. A thick-handled pen will be placed in the participant's hand with the help of velcro, and the space between the edges of the squares will be filled by the participant. The time the participants start from point A and return to point A will be recorded as the test score. The test will be repeated 3 times. | 1 month | |
Secondary | Upper extremity motor function | The Fugl-Meyer Assessment Upper Extremity Scale (FMA) will be used in the upper extremity motor assessment of the participants. FMA questions upper extremity function with 18 items on shoulder/elbow/forearm, five items on wrist, seven items on hand, and three items on coordination. 0 indicates that the action cannot be performed for the item evaluated, and 2 indicates that the action is completed. The maximum score that can be obtained from the assessment is 66. 23-31 points indicate poor upper extremity function, 32-47 points indicate limited function, 48-52 points indicate remarkable function, and 53-66 points indicate complete function. The validity and reliability is quite high. An improvement of 10 or more points in FMA in stroke patients defines clinically significant difference. | 1 month | |
Secondary | Photographic posture measurement | Postural asymmetries and upper extremity position of the participants will be evaluated with photographs taken from the anterior, lateral and posterior while standing comfortably. Colored markers will be placed on the participants' bodies before the photographs are taken. Angles will be calculated from a photo taken by a phone application named "PhysioMaster". | 1 month |
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