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

NCT05747950 | Completed

• 1 other identifier: 2022.12.08
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spasticity as Sequela of Stroke; Limitation, Mobility

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Fugl-Meyer Upper Extremity Rating Scale

  Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes

• Nine Hole Peg Test

  Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 4 minutes

• Stroke-Specific Quality of Life Scale

  Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes

• Box and Block Test (BBT)

  Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 1 minute

• Upper Extremity Motor Activity Diary-28

  Change in Upper Extremity Functionality at 8 Weeks,Two measurements before and after treatment, 5 minutes

Study Arms (3)

Vibration group

OTHER

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.

Other: Vibration

Modified Constraint-Induced Movement Therapy group

OTHER

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.

Other: Modified Constraint-İnduced Movement Therapy

Control group

OTHER

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.

Other: Conventional Therapy

Interventions

Vibration 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.

Vibration group

Modified Constraint-İnduced Movement Therapy 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.

Modified Constraint-Induced Movement Therapy group

Conventional Therapy OTHER

Conventional exercises

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuhal Şevval Gökdere: lead
• Tokat State Hospital: collaborator

Study Sites (1)

Kırıkkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Kırıkkale, Merkez, 71000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31032717 BACKGROUND

• 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.

  PMID: 22507444 RESULT

• 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.

  PMID: 33448755 RESULT

MeSH Terms

Conditions

Stroke; Mobility Limitation

Interventions

Vibration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Researcher: Kırıkkale University, Institute of Health Sciences, 2nd year graduate student with thesis, physiotherapist, Zuhal Şevval Gökdere Participants: In this study, Kırıkkale University Faculty of Medicine, Physical Therapy and Physical Therapy in Rehabilitation Hospital and Tokat State Hospital Volunteer treated in the unit, between 18-75 years old, diagnosed with stroke, 45 individual will be included.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: February 28, 2023
• Study Start: January 10, 2023
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 10, 2023 - June 10, 2023

Locations

TU (1)