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

Z

Zuhal Şevval Gökdere

Status

Completed

Conditions

Stroke
Spasticity as Sequela of Stroke
Limitation, Mobility

Treatments

Other: Vibration
Other: Conventional Therapy
Other: Modified Constraint-İnduced Movement Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05747950
2022.12.08

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups

Vibration group
Other group
Description:
Vibration is defined as "a mechanical stimulus characterized by oscillating movements". has been defined.The first method is a hand held as a local vibration application that can be applied directly to the widest part of the muscle with the object.is named. The second method, called whole body vibration, is a vibration source applied on the platform. Participants immediately after the sessions in addition to conventional physiotherapy. Upper extremity flexor on the hemiplegic side in supine position, 8 weeks, 3 sessions per week with a CE certified vibration device with a frequency of 50-110 Hz and an amplitude of 1-4 mm. Local vibration will be applied for 15 minutes each.
Treatment:
Other: Vibration
Modified Constraint-Induced Movement Therapy group
Other group
Description:
Modified Constraint-İnduced Movement Therapy is a rehabilitation technique that promotes 'repetitive' use of the affected upper extremity in people with upper extremity neurological motor deficits. Constraint-İnduced Movement Therapy upper extremity after stroke it is a rehabilitation approach used to increase functional use. post stroke Approximately 20-25% of surviving patients can meet the motor criteria of mCIMT. Participants In addition to conventional treatment, they can use their intact extremities at home with a shoulder stabilization orthosis.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 Constraint-İnduced Movement Therapy m(CIMT) will be applied.
Treatment:
Other: Modified Constraint-İnduced Movement Therapy
Control group
Other group
Description:
Control group in the training group, will be given a program that includes joint range of motion exercises, strengthening exercises, mobility and transfer activities, and various activities in order to increase participation in daily life activities as a routine conventional treatment in 60-minute sessions, 3 days a week, for 8 weeks.
Treatment:
Other: Conventional Therapy

Trial contacts and locations

1

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Central trial contact

Zuhal Şevval Gökdere, Bachelor

Data sourced from clinicaltrials.gov

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