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

NCT ID: NCT05747950

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2023-06-25

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.

Conditions

Stroke; Spasticity as Sequela of Stroke; Limitation, Mobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vibration group

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.

Group Type: OTHER

Vibration

Intervention Type: OTHER

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 group

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.

Group Type: OTHER

Modified Constraint-İnduced Movement Therapy

Intervention Type: OTHER

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.

Control group

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.

Group Type: OTHER

Conventional Therapy

Intervention Type: OTHER

Conventional exercises

Interventions

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.

Intervention Type: OTHER

Modified Constraint-İnduced 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.

Intervention Type: OTHER

Conventional Therapy

Conventional exercises

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokat State Hospital

OTHER_GOV

Sponsor Role: collaborator

Zuhal Şevval Gökdere

OTHER

Sponsor Role: lead

Responsible Party

Zuhal Şevval Gökdere

physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kırıkkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Kırıkkale, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31032717 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22507444 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33448755 (View on PubMed)

Other Identifiers

2022.12.08

Identifier Type: -

Identifier Source: org_study_id