Clinical trial NCT05747950: Different Treatment Methods Effect on Upper Extremity Spasticity and Decreased Functionality After Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity as Sequela of Stroke
Limitation, Mobility
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
Collaborators: name: Tokat State Hospital
First posted: 2023-02-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the study, 45 individuals between the ages of 18-75 who were diagnosed with stroke and met the inclusion criteria will be recruited. Individuals will be divided into 3 groups according to different treatment methods.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Change in Upper Extremity Spasticity at 8 Weeks,Two measurements before and after treatment, 1 minute
measure: Modified Tardieu Scale (MTS)
timeFrame: Change in Upper Extremity Spasticity at 8 Weeks,Two measurements before and after treatment, 1 minute
Secondary outcomes:
measure: Fugl-Meyer Upper Extremity Rating Scale
timeFrame: Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes
measure: Nine Hole Peg Test
timeFrame: Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 4 minutes
measure: Stroke-Specific Quality of Life Scale
timeFrame: Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes
measure: Box and Block Test (BBT)
timeFrame: Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 1 minute
measure: Upper Extremity Motor Activity Diary-28
timeFrame: Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
state: Merkez
Study officials:
References:
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.
citation: 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 Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.
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. Eur J Phys Rehabil Med. 2021 Aug;57(4):511-519. doi: 10.23736/S1973-9087.21.06542-4. Epub 2021 Jan 15.