Different Treatment Methods Effect on Upper Extremity Spasticity and Decreased Functionality After Stroke

Stroke Clinical Trial

Official title:

The Effect of Local Vibration, Constraint-Induced Movement Therapy (CIMT) and Physiotherapy and Rehabilitation Applied to the Upper Extremity Spasticity and Decreased Functionality After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747950
• Other study ID #: 2022.12.08
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: June 25, 2023

Study information

• Verified date: October 2023
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to objectively and clearly determine the differences between the Spasticity and Decreased Functionality in the Upper Extremity Flexor Group Muscles After Stroke, the Vibration, mBZHT and Physiotherapy and Rehabilitation Applications in terms of treatment process and effectiveness, and to increase the use of the hands and upper extremities in the daily life activities of the patient.

Description:

The World Health Organization has defined stroke as a clinical condition that occurs suddenly, with no apparent cause other than a vascular cause, leading to focal or global cerebral dysfunction, lasting 24 hours or longer, or resulting in death. Stroke ranks third among the causes of death and first in terms of disability. Spasticity, a velocity-dependent increase in muscle tone as a part of upper motor neuron syndrome, is seen in a wide variety of neurological diseases, including stroke, and may occur in the first week after stroke.Rehabilitation aims to inhibit spasticity, improve motor functions, gain independence in activities of daily living, and improve health-related quality of life in stroke patients.This is an observational study within a study.This study was carried out in Kırıkkale University Faculty of Medicine, Physical Therapy and Rehabilitation Hospital and Tokat State Hospital Physical Therapy and Rehabilitation Unit 45 volunteers who were diagnosed with stroke, aged 18-75 years, who met the inclusion criteria of the study planned for the individual.In the study, patients were divided into 3 groups according to different treatment methods the effects of Local Vibration and m(CIMT) applied to upper extremity flexor muscle groups on spasticity and upper extremity functionality will be examined in addition to the conventional rehabilitation program in stroke individuals. A program that includes joint range of motion exercises, strengthening exercises, mobility and transfer activities and various activities to increase participation in daily life activities will be applied routinely for 3 sessions 45 minutes a week for 8 weeks in the first group of patients in the training group.In addition, in addition to conventional physiotherapy, patients in the 1st group immediately after the sessions. Upper extremity flexor on the hemiplegic side in supine position, 3 sessions per week with a CE certified vibration device with a frequency of 50-110 Hz and an amplitude of 1-4 mm.Vibration will be done for 15 minutes each.From the patients in the second group, for 8 weeks, 3 days a week, 60 minutes joint range of motion exercises as routine conventional treatment in sessions,strengthening exercises, mobility and transfer activities, and activities of daily living.In order to increase participation, a program including various activities will be implemented. Moreover after the sessions, patients can use their intact extremities with shoulder stabilization orthosis at home restraint, grasping on the hemiplegic side, using spoons and forks, combing hair daily life activities, 8 weeks, 3 days a week, and approximately 3 hours Modified Restrictor Forced Movement Therapy m(CIMT) will be applied.In the third group, the last group in the third group, for 8 weeks, 3 days a week, 60 minutes joint range of motion exercises as routine conventional treatment only in sessions, strengthening exercises, mobility and transfer activities, and activities of daily living. In order to increase participation, a program including various activities will be implemented. First of all, all individuals; Demographic characteristics such as age, gender, height, weight, case report form will be questioned. Upper extremity of all subjects before and 8 weeks after treatment. Spasticity (tonus, elasticity, stiffness) in flexor group muscles Modified Ashworth and It will be measured with modified Tardieu Scales. Manual dexterity, speed and coordination of upper extremity activities were determined by Fugl-Meyer Upper Limb Evaluation Scale, 9-Hole Peg Test, Box and Block Test [BBT]) and Upper Extremity Motor Activity Diary-28; The quality of life of individuals with stroke, with the Stroke-Specific Quality of Life Scale; Cognitive states of stroke individuals will be evaluated with the Mini Mental Test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Those who are diagnosed with stroke between the ages of 18-75 and can stand
• No cognitive and communication problems
• Persons weighing less than 150 kg
• Patients who have had at least 10 days after Botox application

Exclusion Criteria:

• Individuals who are not stable in terms of vital signs
• Those who have any open wounds on their upper extremities
• Those with spasticity and contracture that prevent sole contact
• Pathological conditions affecting upper extremity sensation (after surgery after fracture etc.)
• Those with a Mini Mental Test score below 24
• Posterior circulation stroke (stroke type in which basilar artery and cerebellum are affected)
• Arterial blood circulation disorders
• Lymphatic Edema
• Those who have been diagnosed with Multiple Sclerosis, Parkinson's and other neurological diseases
• People with vision and hearing problemsPatients who have been diagnosed with stroke for at least 8 weeks

Related Conditions & MeSH terms

• Limitation, Mobility
• Mobility Limitation
• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke

Intervention

Other:
• Vibration
Vibration is used as an alternative to physical exercise in various areas to increase muscle performance and flexibility, improve balance and proprioception, reduce spasticity and increase bone density.
• Modified Constraint-Induced Movement Therapy
Compulsory use therapy is a form of treatment in which the movements of the healthy side are prevented and the use of the weak side is encouraged in the stroke patient.
• Conventional Therapy
Conventional exercises

Locations

Country	Name	City	State
Turkey	Kirikkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation	Kirikkale	Merkez

Sponsors (2)

Lead Sponsor	Collaborator
Zuhal Sevval Gökdere	Tokat State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Reh — View Citation

Hsieh HC, Liao RD, Yang TH, Leong CP, Tso HH, Wu JY, Huang YC. The clinical effect of Kinesio taping and modified constraint-induced movement therapy on upper extremity function and spasticity in patients with stroke: a randomized controlled pilot study. — View Citation

Nasb M, Li Z, S A Youssef A, Dayoub L, Chen H. Comparison of the effects of modified constraint-induced movement therapy and intensive conventional therapy with a botulinum-a toxin injection on upper limb motor function recovery in patients with stroke. Libyan J Med. 2019 Dec;14(1):1609304. doi: 10.1080/19932820.2019.1609304. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale (MAS)	It is the most widely used clinical scale to evaluate spasticity. Despite its widespread clinical use, the reliability of the scale is questioned in some studies. Recent publications indicate that more studies are needed on the reliability of the scale.	Change in Upper Extremity Spasticity at 8 Weeks,Two measurements before and after treatment, 1 minute
Primary	Modified Tardieu Scale (MTS)	Like the MAS, the Modified Tardieu Scale (MTS) is another clinical scale used to assess spasticity. Although it is not as widely used as MAS, it is recommended as a more effective method in the evaluation of spasticity because it measures resistance to passive movement at two different rates. While performing MTS, the extremities are moved passively with V1, V2 and V3 velocities. V1 speed; as slow as possible (slower than the gravity fall velocity of the limb segment), V2 velocity is defined as the extremity fall velocity, and V3 velocity is defined as as fast as possible (faster than the normal gravity fall velocity of the limb). In MTS, V1 velocity can be used to measure passive range of motion, and V2 or V3 velocities can be used to measure spasticity.	Change in Upper Extremity Spasticity at 8 Weeks,Two measurements before and after treatment, 1 minute
Secondary	Fugl-Meyer Upper Extremity Rating Scale	It is a performance-based scale specific to hemiplegia, and each parameter is scored as 0: unsuccessful, 1: partially successful, 2: completely successful performance. Reflex activity, voluntary movements with dynamic flexor and/or extensor synergies, voluntary movements with the use of dynamic flexor and extensor synergies, voluntary movements without or little dependence on synergies, and normal reflex activity parameters are evaluated. When evaluating the wrist, three different functions of the wrist muscles are evaluated in the shoulder, elbow and forearm. In the hemiplegia hand evaluation, 7 movements (flexion, extension and five grip functions) are evaluated. In the evaluation of coordination / speed, finger-nose test is performed for the upper extremity. During this test, tremor, dysmetria, and speed of movement are evaluated. The maximum motor performance score for the upper extremity is 66 points.	Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes
Secondary	Nine Hole Peg Test	It is a simple, fast, manual skill test with proven validity and reliability. It is particularly sensitive to changes in upper extremity performance. The test material consists of nine small sticks made in standard sizes and a nine-hole board on which to place them. NHPT is applied with the patient in a sitting position. The patient is asked to line up the nine sticks in the box on the table as quickly as possible into the holes of the other box and, after finishing, remove them immediately. The test is started with the dominant hand, the time is measured with a stopwatch, and it is started when the hand touches the bars and ends when the last stick is placed in the box.	Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 4 minutes
Secondary	Stroke-Specific Quality of Life Scale	In 1999, Williams et al. Developed by The original scale, consisting of 49 items in total, consists of 12 domains evaluating mobility, energy, upper extremity function, self-care, occupation/productivity, temperament, social role, family role, vision, language, thinking, and personality traits.	Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes
Secondary	Box and Block Test (BBT)	The Box-Block Test was developed to assess rough manual dexterity and is a very simple, practical and quick test to use. A box and small wooden blocks are used for the test, which is divided into two equal areas right in the middle. Small wooden blocks are all placed on one side of the box. For the test, the patient is told to throw the wooden blocks in one section into the other section as quickly as possible and 60 seconds are given. The test is applied to both the dominant and non-dominant hand and the number of wooden blocks thrown to the opposite side gives the total score. The test is particularly suitable for patients with limited grip and dexterity.	Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 1 minute
Secondary	Upper Extremity Motor Activity Diary-28	This scale, which aims to evaluate the function of the hemiparetic upper extremity, was developed by Uswatte et al. in 2006. 30 upper extremity functions are evaluated and scored with 2 different scales as "use level" and "use quality". The score for each scale is calculated by summing the scores and dividing by the number of marked items.	Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes