Effects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic Elbow

NCT05626790 | Completed DMC

• 1 other identifier: DR04102022
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Spasticity, Muscle

Keywords

Stroke; Elbow Flexor Spasticity; PNF Stretching; Muscle Architecture; Muscle Viscoelastic Properties; Static Stretching

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Range of Motion

  1 month

• Proprioception

  1 month

• Upper extremity motor performance

  1 month

• Upper extremity motor function

  1 month

• Photographic posture measurement

  1 month

Study Arms (2)

PNF Stretching

EXPERIMENTAL

All participants will join an exercise program that will last 20-30 minutes, 5 days a week for 4 weeks, especially targeting proximal stabilization. In addition to the exercises, three different types of PNF stretching will be applied to the participants in the PNF stretching group for 4 weeks, 5 days a week.

Other: Exercise; Other: PNF Stretching

Prolonged Stretching

ACTIVE COMPARATOR

All participants will join an exercise program that will last 20-30 minutes, 5 days a week for 4 weeks, especially targeting proximal stabilization. The exercise program is expected to take 20-30 minutes. Each exercise will be done in 3 sets. Each set will include 10 repetitions. In weight-bearing exercises, the participant will be asked to hold the position for 10 seconds. In addition to the exercises given to both of the groups, static stretching will be applied to the elbow flexors in 2 different positions for 4 weeks, 5 days a week.

Other: Exercise; Other: Prolonged Stretching

Interventions

Exercise OTHER

All participants will join an exercise program that will last 20-30 minutes, 5 days a week for 4 weeks, especially targeting proximal stabilization. The exercise program is expected to take 20-30 minutes. Each exercise will be done in 3 sets. Each set will include 10 repetitions. In weight-bearing exercises, the participant will be asked to hold the position for 10 seconds.

PNF Stretching; Prolonged Stretching

PNF Stretching OTHER

In addition to the exercises, three different PNF stretching will be applied to the participants in the PNF stretching group for 4 weeks, 5 days a week. 1. Biceps: Flex-Add-ER repositioned half pattern 2. Brachioradialis: Flex-Abd-ER repositioned half pattern 3. Brachialis: Ext-Add-IR half pattern In the supine position, the physiotherapist will move the forearm to the end of the passive range of motion according to the direction of limitation. Secondly, participants will be asked to perform a submaximal isometric contraction of the target muscle with an emphasis on rotation for 10 seconds. After this contraction, participants will be asked to relax for 5 seconds. In the third phase, the elbow joint will be actively repositioned to the new range of motion, and the physical therapist will help to the patient to keep this position for an additional 10 seconds. This procedure will be repeated 10 times with a 10 secs resting period between two consecutive stretches.

PNF Stretching

Prolonged Stretching OTHER

In addition to the exercises given to both of the groups, static stretching will be applied to the elbow flexors in 2 different positions for 4 weeks, 5 days a week. Participants will need to complete 5 sets of 1.5-minute stretching and 30-second rest periods for both of the two stretching positions listed below. The total duration of the stretches to be performed together with the rest periods will be 20 minutes. 1. In supine position, the shoulder will be positioned in 90° abduction and internal rotation, the forearm will be positioned in pronation, then the shoulder will be slowly extended. In this way, especially the Biceps Brachii and Brachioradialis muscles are expected to be stretched. 2. In supine position, the shoulder will be positioned in 90° abduction and maximum external rotation, and the forearm will be positioned in full supination. In this way, especially the brachialis muscle is expected to be stretched.

Prolonged Stretching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İSÜFİZYOTEM (Istinye University Physiotherapy and Rehabilitation Application and Research Center)

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Exercise; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Ayşe Zengin Alpözgen, Assoc Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Çiçek Günday, PhD(c)

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Yıldıray Tutpınar, Asst. Prof.

  Istinye University Hospital Liv Hospital Bahcesehir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 25, 2022
• Study Start: November 14, 2022
• Primary Completion: March 1, 2024
• Study Completion: June 10, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

TU (1)