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Kinesio Tape vs Neuromuscular Stimulation For Conserative of Treatment Hemiplegic Shoulder

Primary Purpose

Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NMES
Kinesiotape
Standardized Physiotherapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Taping, stroke, rehabilitation, shoulder pain, electrical stimulation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • had unilateral ischemic brain injury or intracerebral hemorrhage at least 1 week to maximum 24 months after the onset of single stroke without other diagnosed neurological or systematic deficits.
  • had enough cognition to be able to follow the training protocol as assessed by Mini Mental State Examination.
  • age 30-70 years.

Exclusion Criteria:

  • had a severe injury of the rotator cuff or a shoulder surgery history.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    NMES group

    Kinesiotape Group

    Control

    Arm Description

    This group of patients received Neuromuscular Electrical Stimulation (NMES) and standardized physiotherapy and rehabilitation protocol

    This group of patients received standardized physiotherapy and rehabilitation protocol and at the same time kinesiotape was applied to their affected shoulder

    This group of patients received only a standardized physiotherapy and rehabilitation protocol

    Outcomes

    Primary Outcome Measures

    Motor Activity Log-28,
    Motor Activity Log-28, is a clinical questionnaire developed to evaluate daily use of the hemiparetic arm outside of the treatment setting

    Secondary Outcome Measures

    Pain Visual Analogue Scale
    Presence of shoulder pain on the affected side was scored using a 100-mm (10-cm) visual analog scale (VAS). The patients were instructed to mark their pain intensity on a 100-mm horizontal line, in which 0 denoted no pain and 100 mm denoted maximum pain felt by the patient. The pain felt with activity and at rest was recorded separately and repeated after the treatment.
    Brunnstrom Stages
    Brunnstrom stages has been used to identify and defined to quantify the recovery stages after stroke. Brunnstrom defined six stages of motor recovery and described how the hemiplegic upper limb progressed as a method for assessing recovery. Higher Brunnstrom scores indicated increased motor recovery.
    Fugl-Meyer Sensorimotor Assessment Scale (FM)
    FM is an impairment assessment tool that has been shown to be reliable and valid. It consists of three independent sections: motricity and sensation of the upper limb, motricity and sensation of the lower limb, and balance.

    Full Information

    First Posted
    October 14, 2016
    Last Updated
    February 8, 2019
    Sponsor
    Hacettepe University
    Collaborators
    Inonu University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02937311
    Brief Title
    Kinesio Tape vs Neuromuscular Stimulation For Conserative of Treatment Hemiplegic Shoulder
    Official Title
    Kinesio Tape vs Neuromuscular Stimulation For Conserative of Treatment Hemiplegic Shoulder: Which One Improves Function More?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University
    Collaborators
    Inonu University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to compare the effects of kinesiotaping, neuromuscular electric stimulation (NMES), and neuromuscular training on pain, and motor activity and function in patients with upper extremity hemiplegia.
    Detailed Description
    Hemiplegia in the shoulder complex and upper limb is a common secondary impairment as a result of a cerebrovascular event. Although most stroke survivors regain independent ambulation, many fail to regain functional use of their impaired upper limb. Actually the pathogenesis of post-stroke shoulder pain seems to be multifactorial; differential diagnosis is often difficult. Changes in the shoulder complex makes the glenohumeral joint vulnerable to subluxation, which may cause pain. Traction of capsule and soft tissue related subluxation of the shoulder may take place in the early stages; limited range of motion due to spasticity may develop in the later stages of stroke. These biomechanical problems may be the possible reason for pain. Rotator cuff tears and rotator cuff and deltoid tendinopathies are also possible symptoms related to hemiplegic shoulder observed in magnetic resonance imaging findings. These problems in the shoulder disturb the kinetic chain system that connects the segments and works sequentially from proximal to distal to achieve the targeted movement. When a biomechanical impairment happens in the shoulder or any other segment of the body, a loss in the energy produced in the body and transferred to the upper extremity occurs. This loss adversely affects the quality of the movement . Regaining functional use of the upper limb after a stroke is a challenging task for the patient, which has a significant impact on the individual's physical, psychological, and emotional well-being. Lack of functional ability in the upper extremities after stroke restricts use and causes asymmetric posture and contracture in daily life, thus exacerbating functional limitations of the upper limb. Also, low upper limb motor function is related to the risk of soft tissue injury during rehabilitation. A patient experienced a stroke may not feel any pain due to subluxation. However, different muscle groups may be vulnerable to overstretching, increased contraction, and premature fatigue. This can decrease the coordination of muscular activity and inhibit the functional use of the upper extremity. The posterior fibers of the deltoid, the supraspinatus, and the infraspinatus are the most important muscles that prevent the subluxation of the glenohumeral joint.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiplegia
    Keywords
    Taping, stroke, rehabilitation, shoulder pain, electrical stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NMES group
    Arm Type
    Experimental
    Arm Description
    This group of patients received Neuromuscular Electrical Stimulation (NMES) and standardized physiotherapy and rehabilitation protocol
    Arm Title
    Kinesiotape Group
    Arm Type
    Experimental
    Arm Description
    This group of patients received standardized physiotherapy and rehabilitation protocol and at the same time kinesiotape was applied to their affected shoulder
    Arm Title
    Control
    Arm Type
    Experimental
    Arm Description
    This group of patients received only a standardized physiotherapy and rehabilitation protocol
    Intervention Type
    Other
    Intervention Name(s)
    NMES
    Other Intervention Name(s)
    Neuromuscular electric stimulation
    Intervention Description
    Participants received NMES using a portable, page-sized battery-powered stimulation device, which delivered current-regulated, charge-balanced, asymmetrical biphasic pulses. The implementation was done on the deltoid and supraspinatus muscles
    Intervention Type
    Other
    Intervention Name(s)
    Kinesiotape
    Other Intervention Name(s)
    Taping
    Intervention Description
    The deltoid and supraspinatus muscles were taped in this study to align the shoulder in correct position to facilitate the function and achieve preferred body alignment. For supraspinatus application, Y strip tape was applied from the muscle insertion at the greater tuberosity of the humerus to its origin at the supraspinatus fossa of the scapula while the muscle was in an overstretched position. No tension was applied to the tape. For deltoid application, Y-shaped tape was used by placing the anchor acromion process. The front tail was implemented in the extended arm position, while the back tail was implemented in the horizontal abducted arm position. Both tails ended below the deltoid tubercule of the humerus. No tension was applied during application.
    Intervention Type
    Other
    Intervention Name(s)
    Standardized Physiotherapy
    Other Intervention Name(s)
    Physiotherapy and Rehabilitation
    Intervention Description
    All participants received rehabilitation including Bobath neurophysiological approach. Bobath approach and other exercise programs were implemented early after the onset of the stroke to prevent immobility and soft tissue contracture and to alter the muscle tone to gain mobility. Through the exercise program and use of weight-bearing techniques, the therapist attempted to maintain and improve trunk and shoulder alignment to allow the functional use of the upper extremity.
    Primary Outcome Measure Information:
    Title
    Motor Activity Log-28,
    Description
    Motor Activity Log-28, is a clinical questionnaire developed to evaluate daily use of the hemiparetic arm outside of the treatment setting
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Pain Visual Analogue Scale
    Description
    Presence of shoulder pain on the affected side was scored using a 100-mm (10-cm) visual analog scale (VAS). The patients were instructed to mark their pain intensity on a 100-mm horizontal line, in which 0 denoted no pain and 100 mm denoted maximum pain felt by the patient. The pain felt with activity and at rest was recorded separately and repeated after the treatment.
    Time Frame
    1 month
    Title
    Brunnstrom Stages
    Description
    Brunnstrom stages has been used to identify and defined to quantify the recovery stages after stroke. Brunnstrom defined six stages of motor recovery and described how the hemiplegic upper limb progressed as a method for assessing recovery. Higher Brunnstrom scores indicated increased motor recovery.
    Time Frame
    1 month
    Title
    Fugl-Meyer Sensorimotor Assessment Scale (FM)
    Description
    FM is an impairment assessment tool that has been shown to be reliable and valid. It consists of three independent sections: motricity and sensation of the upper limb, motricity and sensation of the lower limb, and balance.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: had unilateral ischemic brain injury or intracerebral hemorrhage at least 1 week to maximum 24 months after the onset of single stroke without other diagnosed neurological or systematic deficits. had enough cognition to be able to follow the training protocol as assessed by Mini Mental State Examination. age 30-70 years. Exclusion Criteria: had a severe injury of the rotator cuff or a shoulder surgery history.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gul O KARABICAK, Phd
    Organizational Affiliation
    Baskent University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Kinesio Tape vs Neuromuscular Stimulation For Conserative of Treatment Hemiplegic Shoulder

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