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
About this trial
This is an interventional treatment trial for Hemiplegia focused on measuring Taping, stroke, rehabilitation, shoulder pain, electrical stimulation
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.
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
NCT ID
NCT02937311
First Posted
October 14, 2016
Last Updated
February 8, 2019
Sponsor
Hacettepe University
Collaborators
Inonu University
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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