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出境医 / 临床实验 / Effects of Kinesio Taping for Upper Limb Function of Stroke Patients

Effects of Kinesio Taping for Upper Limb Function of Stroke Patients

Study Description
Brief Summary:
Patients with stroke in the brain, due to central nervous system damage, lack of correct action patterns, limited joint movement of upper limbs, affecting the patient's performance. The Kinesio taping effect is to facilitate the muscle activity of upper limb. This program is intended to provide a treatment for patients with chronic stroke, and to observe their upper limb movements before and after using the Kinesio taping.

Condition or disease Intervention/treatment Phase
Stroke Other: Kinesio taping Not Applicable

Detailed Description:
Motor impairment is the main cause of disability after stroke, leading to major health problems. Research has shown that the most common consequence of stroke is the paresis of limbs.The ability to live independently after a stroke depends on the recovery of motor functions,particularly those of the upper limb.The core concept of the Kinesio taping is to influence the brain through the sensory input, stimulate the nervous system, and improve the motor performance of the stroke patient.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Kinesio Taping for Upper Limb Function of Stroke Patients
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : July 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: KT group
The paretic upper limb is a common consequence of stroke that increases activity limitation.
 Other: Kinesio taping
In KT group, KT was applied using the insertion-origin muscle and space-correction technique of affected upper limb with stroke patients.
Outcome Measures
Primary Outcome Measures :
  1. Change in Fugl-Meyer Assessment (FMA) from pre to post-intervention. [ Time Frame: up to 30 minutes. ]
    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

  2. Change in Action Research Arm Test (ARAT) from pre to post-intervention. [ Time Frame: up to 30 minutes. ]
    The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among post-stroke hemiplegia.

  3. Change in Box and Block Test (BBT) from pre to post-intervention. [ Time Frame: up to 30 minutes. ]
    The Box and Block Test (BBT) measures unilateral gross manual dexterity for stroke patients.


Secondary Outcome Measures :
  1. Change in Motor Activity Log (MAL) from pre to post-intervention. [ Time Frame: up to 20 minutes. ]
    The Motor Activity Log (MAL) is a semi-structured interview to assess arm function.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-stroke hemiplegia, at least 6 months since onset
  • Ability to communicate and understand instructions.

Exclusion Criteria:

  • Skin problems, wounds, or infection on the affected upper limb.
  • The experience of using the Kinesio taping.
  • A history of allergy tothe Kinesio taping.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 2, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Change in Fugl-Meyer Assessment (FMA) from pre to post-intervention. [ Time Frame: up to 30 minutes. ]
    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
  • Change in Action Research Arm Test (ARAT) from pre to post-intervention. [ Time Frame: up to 30 minutes. ]
    The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among post-stroke hemiplegia.
  • Change in Box and Block Test (BBT) from pre to post-intervention. [ Time Frame: up to 30 minutes. ]
    The Box and Block Test (BBT) measures unilateral gross manual dexterity for stroke patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		Change in Motor Activity Log (MAL) from pre to post-intervention. [ Time Frame: up to 20 minutes. ]
The Motor Activity Log (MAL) is a semi-structured interview to assess arm function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Kinesio Taping for Upper Limb Function of Stroke Patients
Official Title  ICMJE Effects of Kinesio Taping for Upper Limb Function of Stroke Patients
Brief Summary Patients with stroke in the brain, due to central nervous system damage, lack of correct action patterns, limited joint movement of upper limbs, affecting the patient's performance. The Kinesio taping effect is to facilitate the muscle activity of upper limb. This program is intended to provide a treatment for patients with chronic stroke, and to observe their upper limb movements before and after using the Kinesio taping.
Detailed Description Motor impairment is the main cause of disability after stroke, leading to major health problems. Research has shown that the most common consequence of stroke is the paresis of limbs.The ability to live independently after a stroke depends on the recovery of motor functions,particularly those of the upper limb.The core concept of the Kinesio taping is to influence the brain through the sensory input, stimulate the nervous system, and improve the motor performance of the stroke patient.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Other: Kinesio taping
In KT group, KT was applied using the insertion-origin muscle and space-correction technique of affected upper limb with stroke patients.
Study Arms  ICMJE Experimental: KT group
The paretic upper limb is a common consequence of stroke that increases activity limitation.
Intervention: Other: Kinesio taping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post-stroke hemiplegia, at least 6 months since onset
  • Ability to communicate and understand instructions.

Exclusion Criteria:

  • Skin problems, wounds, or infection on the affected upper limb.
  • The experience of using the Kinesio taping.
  • A history of allergy tothe Kinesio taping.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935113
Other Study ID Numbers  ICMJE N201811021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taipei Medical University WanFang Hospital
Study Sponsor  ICMJE Taipei Medical University WanFang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taipei Medical University WanFang Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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