search
Back to results

Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Kinesiotaping
modified Constraint Induced Movement Training
Sham taping
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, Kinesiotaping, constraint induced movement therapy, sonography

Eligibility Criteria

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

Inclusion Criteria:

  • The patients have a stroke with hemiplegia (duration is 3~12 months after stroke).
  • Patients who are able to perform hand grasp.
  • Patients who could slightly do fingers extension and minimal wrist extension. (ability of extension at least 10 degrees at the metacarpophalangeal and interphalangeal joints and 20 degrees at the wrist.)

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
  • allergy history when application of KT materials

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Experimental

Arm Label

KT group

mCIMT group

KT+mCIMT group

Arm Description

the patients will perform Kinesiotaping for 5 days per week for 3 weeks

the unaffected limb will be constraint for 2 hours a day, 5 days a week for three weeks. And they will receive sham taping on the affected limb.

the patients will perform Kinesiology taping for 5 days per week for 3 weeks, and while being taped, the modified Constraint Induced Movement Training would be also executed.

Outcomes

Primary Outcome Measures

the change from baseline to time of Fugl-Meyer assessment
a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance.
the change from baseline to time of Musculoskeletal sonography
an experienced physiatrist will evaluate the findings on sonography, sonoelastography, and shear wave velocity (SWV). The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degrees 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 at follow up for each patient. The SWV will be done in the longitudinal/transverse planes 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.
the change from baseline to time of MAS scale
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Ashworth scale). In this scale, muscle tone would be assessed by quick stretch of muscle belly. The scoring criteria are as follows. 0, no increase in muscle tone; 1, Slight increase in muscle tone; 2, More marked increase in muscle tone through most of the ROM; 3, considerable increase in muscle tone; 4, affected part(s) rigid in flexion or extension.

Secondary Outcome Measures

the change from baseline to time of Brunnstrom stage
a therapist will measure motor recovery stage (Brunnstrom stage)
the change from baseline to time of modified Tardieu scale
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Tardieu scale).
the change from baseline to time of existence of sensation
a therapist will measure the sensation, including light touch, pinprick touch, proprioception.
the change from baseline to time of quality of life by Stroke Impact Scale
Stroke Impact Scale would be used to measure the independence of daily activities. It is a self-reported questionnaire. The contents involve various aspect of life. The high the grade, the more serious the life is affected.
the change from baseline to time of quality of life by Barthel Index
Barthel Index would be used to measure the independence of daily activities. It is a form that contains different activities of daily living. The higher the outcome grades, the better the level of independence.
the change from baseline to time of functional performance by box and block test
box and block test would be used to assess the grasping and release performance of the affected hand.
the change from baseline to time of functional performance by STEF
Simple Test for Evaluating Hand Function (STEF) would be used to assess the hand function by executing various types of grasping.
the change from baseline to time of functional performance by Wolf Motor Function Test
Wolf Motor Function Test would be used for measuring hand functions.

Full Information

First Posted
September 18, 2018
Last Updated
January 21, 2020
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03682666
Brief Title
Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke
Official Title
The Clinical Effect and Sonographic Findings of Kinesiotaping and Constraint Induced Movement Therapy in Upper Extremity Function and Spasticity in Patients With Subacute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In stroke patients, the most common neurological deficits were motor impairment, loss of somatosensation, abnormal muscle tone, and impaired fractionated movement at affected limbs. Therefore, the investigators try to facilitate upper extremity function and normalize the muscle tone to enlarge their capacity to perform daily activities and to improve life quality by modified constraint-induced movement therapy (mCIMT) and Kinesiotaping (KT). The investigators will collect 90 subacute stroke patients with hemiplegia in this study. These 90 patients will be randomly divided into 3 groups. In KT group (n=30), the patients will perform Kinesiology taping for 5 days per week for 3 weeks. In mCIMT group (n=30), the patient will receive constraint the unaffected limb for 2 hours a day, 5 days a week for three weeks. In KT+mCIMT group, the KT and mCIMT interventions would be performed for 5 days a week in three weeks. All the patients in KT, CIMT and KT+mCIMT groups will receive 20-minute hand function training twice daily for 5 days per week for 3 weeks. Before intervention, immediately and 3 week later after intervention, all patients will receive the physical examinations including motor recovery stage (Brunnstrom stage), spasticity (modified Ashworth scale and Tardieu scale), and sensation. Fugl-Meyer assessment for upper extremity (FMA-UE), box and block test, Simple Test for Evaluating Hand Function (STEF), and Wolf Motor Function Test for hand function, ADL and quality of life assessment and musculoskeletal sonography for affected forearms will be also evaluated in this study. The aims of this study are: To investigate the effect of Kinesiotaping and modified CIMT in improving upper extremity function and spasticity for subacute stroke patients with hemiplegia. To explore the role of sonoelastography and shear wave velocity in poststroke spasticity assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Kinesiotaping, constraint induced movement therapy, sonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KT group
Arm Type
Active Comparator
Arm Description
the patients will perform Kinesiotaping for 5 days per week for 3 weeks
Arm Title
mCIMT group
Arm Type
Sham Comparator
Arm Description
the unaffected limb will be constraint for 2 hours a day, 5 days a week for three weeks. And they will receive sham taping on the affected limb.
Arm Title
KT+mCIMT group
Arm Type
Experimental
Arm Description
the patients will perform Kinesiology taping for 5 days per week for 3 weeks, and while being taped, the modified Constraint Induced Movement Training would be also executed.
Intervention Type
Device
Intervention Name(s)
Kinesiotaping
Intervention Description
Kinesio tape would be applied over the extensor muscles of the affected hand for facilitating the extension of hand. We will apply the tape from the upper 1/3 length of dorsal side of the forearm and split the tape into five equal bars to the distal interphalangeal joint of each finger along the finger bones. This intervention would be executed for five days per week for three weeks.
Intervention Type
Behavioral
Intervention Name(s)
modified Constraint Induced Movement Training
Intervention Description
A 2-hour time period would be arranged to constraint patient's unaffected hand by using a bandage by a therapist. During this two hours, patients would not be allowed to use this unaffected to do any activity, so that they will need to use the affected hand. The caregivers would also be educated to provide less help if it is not necessary. This intervention would be executed two hours a day for five days per week, for three weeks.
Intervention Type
Device
Intervention Name(s)
Sham taping
Intervention Description
A short piece of kinesio tape would be cut into half and applied over the lateral side of the forearm from the lateral epicondyle till the half of the forearm. The tape would not cover the both the flexor and extensor muscle bellies.
Primary Outcome Measure Information:
Title
the change from baseline to time of Fugl-Meyer assessment
Description
a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance.
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of Musculoskeletal sonography
Description
an experienced physiatrist will evaluate the findings on sonography, sonoelastography, and shear wave velocity (SWV). The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degrees 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 at follow up for each patient. The SWV will be done in the longitudinal/transverse planes 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
3rd week, and 6th week
Title
the change from baseline to time of MAS scale
Description
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Ashworth scale). In this scale, muscle tone would be assessed by quick stretch of muscle belly. The scoring criteria are as follows. 0, no increase in muscle tone; 1, Slight increase in muscle tone; 2, More marked increase in muscle tone through most of the ROM; 3, considerable increase in muscle tone; 4, affected part(s) rigid in flexion or extension.
Time Frame
3rd week, and 6th week
Secondary Outcome Measure Information:
Title
the change from baseline to time of Brunnstrom stage
Description
a therapist will measure motor recovery stage (Brunnstrom stage)
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of modified Tardieu scale
Description
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Tardieu scale).
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of existence of sensation
Description
a therapist will measure the sensation, including light touch, pinprick touch, proprioception.
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of quality of life by Stroke Impact Scale
Description
Stroke Impact Scale would be used to measure the independence of daily activities. It is a self-reported questionnaire. The contents involve various aspect of life. The high the grade, the more serious the life is affected.
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of quality of life by Barthel Index
Description
Barthel Index would be used to measure the independence of daily activities. It is a form that contains different activities of daily living. The higher the outcome grades, the better the level of independence.
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of functional performance by box and block test
Description
box and block test would be used to assess the grasping and release performance of the affected hand.
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of functional performance by STEF
Description
Simple Test for Evaluating Hand Function (STEF) would be used to assess the hand function by executing various types of grasping.
Time Frame
3rd week, and 6th week
Title
the change from baseline to time of functional performance by Wolf Motor Function Test
Description
Wolf Motor Function Test would be used for measuring hand functions.
Time Frame
3rd week, and 6th week

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: The patients have a stroke with hemiplegia (duration is 3~12 months after stroke). Patients who are able to perform hand grasp. Patients who could slightly do fingers extension and minimal wrist extension. (ability of extension at least 10 degrees at the metacarpophalangeal and interphalangeal joints and 20 degrees at the wrist.) 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 allergy history when application of KT materials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chi Huang, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke

We'll reach out to this number within 24 hrs