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Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients

Primary Purpose

Stroke, Upper Extremity Spasticity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinesiotaping
stretching exercise
OT rehabilitation program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, spasticity, Kinesiotaping, sonography, exercise

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke with hemiplegia (duration is 3~6 months after stroke).
  • The upper extremity function of participated patients could perform hand grasp and release movements.

Exclusion Criteria:

  • age is younger than 18 years or older than 80 years
  • previous history of upper extremity tendon or neuromuscular injury
  • any other systemic neuromuscular disease
  • cognition or language impairment leading to communication difficulty

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    with Kinesiotaping

    control group

    Arm Description

    stretching exercises combined with Kinesiotaping regular OT rehabilitation program for 3 weeks

    the patients will receive 15-min stretching exercises regular OT rehabilitation program for 3 weeks

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function
    A physical therapist will use Fugl-Meyer assessment for upper extremity (FMA-UE) to evaluate patient's hand function and analyze the changes on the score of it from baseline till third week and fifth week.
    Modified Ashworth scale for level of spasticity of affected arm
    A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.

    Secondary Outcome Measures

    the change from baseline on hemiplegic upper extremity sonography
    for the flexor carpal ulnaris (FCU), flexor carpal radialis (FCR), and flexor digitorum superficialis (FDS) muscles. The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degree and the forearm full supination. The measured levels for evaluating FCR, FCU, and FDS muscles will be recorded at first time and use the same level after intervention for each patient. The SWV will be done in the transverse plane and be performed at the maximal cross-section area of the muscles and repeatedly measured for 7 times for each muscle. The sonoelastography will be applied in the longitudinal plane of the detected muscles at the same level of the SWV.
    Brunnstrom motor recovery stage for motor ability
    A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till third week and fifth week.
    Modified Tardieu scale for level of spasticity of affected arm
    A physical therapist will measure the level of spasticity in affected arm by using modified Tardieu scale.

    Full Information

    First Posted
    December 27, 2016
    Last Updated
    September 21, 2018
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03024190
    Brief Title
    Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients
    Official Title
    The Clinical Effect and Sonographic Findings of Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    July 2018 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a brain injury leading to limbs weakness and impaired coordination between agonist and antagonist contraction. PSS leads some physical impairments and functional deficits. The clinical managements for PSS are stretching and range of motion (ROM) exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications, local injection with phenol or botulism, or surgery. Recently, some investigators tried to use Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in walking ability and upper extremity function facilitation after stroke. 40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40 patients will be randomly divided into the experimental and control groups. In experimental group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. In the control group (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week post intervention, all patients will receive associated physical examinations, hand function evaluations, and sonography.
    Detailed Description
    In this study, 40 subacute stroke patients (duration is 3~6 months after stroke) with hemiplegia would be enrolled. Each stroke patient is diagnosed by a neurologist according to the history, physical examination, and brain imaging evaluation. These 40 patients would be randomly divided into a experimental or a control group. All patients in the control and experimental groups will both receive regular rehabilitation therapy including occupational therapy (OT) 3 times per week and one hour for one session OT intervention. Additionally, 15- min stretching exercise for upper extremity twice daily will be performed for 3 weeks in this study. KT intervention in the experimental group: The technique of KT for spastic wrist and fingers in stroke patient will be performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm. The KT will be applied for 5 days one week for 3 weeks. In this study, all patients in the control and experimental groups will receive the following evaluations before intervention, immediately post intervention, and 2-week after intervention: Physical examinations (modified shworth scale and Tardieu scale), Hand function evaluation (Fugl-Meyer Assessment for upper extremity, box and block test, and Minnesota Manual Dexterity Test), and Musculoskeletal sonography (sonoelastography and shear wave velocity). SPSS software will be used to record and analysis the collecting data. Investigators will analyze and compare the findings of physical examinations, upper extremity function assessments, and musculoskeletal sonography within and between the experimental and control groups before and after interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Upper Extremity Spasticity
    Keywords
    stroke, spasticity, Kinesiotaping, sonography, exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    with Kinesiotaping
    Arm Type
    Experimental
    Arm Description
    stretching exercises combined with Kinesiotaping regular OT rehabilitation program for 3 weeks
    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    the patients will receive 15-min stretching exercises regular OT rehabilitation program for 3 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Kinesiotaping
    Intervention Description
    The technique of Kinesiotaping for spastic wrists and fingers in stroke patients is performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm.
    Intervention Type
    Other
    Intervention Name(s)
    stretching exercise
    Intervention Description
    15- min stretching exercise for upper extremity twice daily
    Intervention Type
    Other
    Intervention Name(s)
    OT rehabilitation program
    Intervention Description
    regular rehabilitation program for 3 weeks
    Primary Outcome Measure Information:
    Title
    Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function
    Description
    A physical therapist will use Fugl-Meyer assessment for upper extremity (FMA-UE) to evaluate patient's hand function and analyze the changes on the score of it from baseline till third week and fifth week.
    Time Frame
    baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.
    Title
    Modified Ashworth scale for level of spasticity of affected arm
    Description
    A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.
    Time Frame
    baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
    Secondary Outcome Measure Information:
    Title
    the change from baseline on hemiplegic upper extremity sonography
    Description
    for the flexor carpal ulnaris (FCU), flexor carpal radialis (FCR), and flexor digitorum superficialis (FDS) muscles. The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degree and the forearm full supination. The measured levels for evaluating FCR, FCU, and FDS muscles will be recorded at first time and use the same level after intervention for each patient. The SWV will be done in the transverse plane and be performed at the maximal cross-section area of the muscles and repeatedly measured for 7 times for each muscle. The sonoelastography will be applied in the longitudinal plane of the detected muscles at the same level of the SWV.
    Time Frame
    baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.
    Title
    Brunnstrom motor recovery stage for motor ability
    Description
    A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till third week and fifth week.
    Time Frame
    baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.
    Title
    Modified Tardieu scale for level of spasticity of affected arm
    Description
    A physical therapist will measure the level of spasticity in affected arm by using modified Tardieu scale.
    Time Frame
    baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: stroke with hemiplegia (duration is 3~6 months after stroke). The upper extremity function of participated patients could perform hand grasp and release movements. Exclusion Criteria: age is younger than 18 years or older than 80 years previous history of upper extremity tendon or neuromuscular injury any other systemic neuromuscular disease cognition or language impairment leading to communication difficulty
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu Chi Huang, Bachelor
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    undecided
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