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
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, spasticity, Kinesiotaping, sonography, exercise
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
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
NCT ID
NCT03024190
First Posted
December 27, 2016
Last Updated
September 21, 2018
Sponsor
Chang Gung Memorial Hospital
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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Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients
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