StrokeNCT03682666
Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke
A study testing Kinesiotaping and modified Constraint Induced Movement Training in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Kinesiotaping and modified Constraint Induced Movement Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Stroke
- Being tested
- Kinesiotaping, modified Constraint Induced Movement Training, Sham taping
- Keywords
- stroke, Kinesiotaping, constraint induced movement therapy, sonography
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDevice
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.
modified Constraint Induced Movement TrainingBehavioural
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.
Sham tapingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| KT group | Active comparator | the patients will perform Kinesiotaping for 5 days per week for 3 weeks Receives: Device: Kinesiotaping |
| mCIMT group | Sham comparator | 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. Receives: Behavioral: modified Constraint Induced Movement Training; Device: Sham taping |
| KT+mCIMT group | Experimental | 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. Receives: Device: Kinesiotaping; Behavioral: modified Constraint Induced Movement Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd week, and 6th week
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.
Measured: 3rd week, and 6th week
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.
Measured: 3rd week, and 6th week
Secondary outcomes (8)
the change from baseline to time of Brunnstrom stage
a therapist will measure motor recovery stage (Brunnstrom stage)
Measured: 3rd week, and 6th week
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).
Measured: 3rd week, and 6th week
the change from baseline to time of existence of sensation
a therapist will measure the sensation, including light touch, pinprick touch, proprioception.
Measured: 3rd week, and 6th week
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.
Measured: 3rd week, and 6th week
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.
Measured: 3rd week, and 6th week
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.
Measured: 3rd week, and 6th week
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.
Measured: 3rd week, and 6th week
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.
Measured: 3rd week, and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Oct 2018
- Primary completion6 Nov 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chi Huang, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682666
- Sponsor's protocol ID
- CMRPG8H0701
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03682666
- Acronym / sponsor ID
- CMRPG8H0701
- Conditions
- Stroke
- Keywords
- stroke, Kinesiotaping, constraint induced movement therapy, sonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KT group | Active comparator | Device: Kinesiotapingthe patients will perform Kinesiotaping for 5 days per week for 3 weeks |
| mCIMT group | Sham comparator | Behavioral: modified Constraint Induced Movement Training, Device: Sham tapingthe 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. |
| KT+mCIMT group | Experimental | Device: Kinesiotaping, Behavioral: modified Constraint Induced Movement Trainingthe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapingKinesio 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. | Device | KT group, KT+mCIMT group |
| modified Constraint Induced Movement TrainingA 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. | Behavioural | KT+mCIMT group, mCIMT group |
| Sham tapingA 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. | Device | mCIMT group |
Primary outcome
the change from baseline to time of Fugl-Meyer assessment
Time frame: 3rd week, and 6th week
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
Time frame: 3rd week, and 6th week
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
Time frame: 3rd week, and 6th week
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.
8 secondary outcomes
the change from baseline to time of Brunnstrom stage
Time frame: 3rd week, and 6th week
the change from baseline to time of modified Tardieu scale
Time frame: 3rd week, and 6th week
the change from baseline to time of existence of sensation
Time frame: 3rd week, and 6th week
the change from baseline to time of quality of life by Stroke Impact Scale
Time frame: 3rd week, and 6th week
the change from baseline to time of quality of life by Barthel Index
Time frame: 3rd week, and 6th week
the change from baseline to time of functional performance by box and block test
Time frame: 3rd week, and 6th week
the change from baseline to time of functional performance by STEF
Time frame: 3rd week, and 6th week
the change from baseline to time of functional performance by Wolf Motor Function Test
Time frame: 3rd week, and 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chi Huang, MD study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping and modified Constraint Induced Movement Training in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change from baseline to time of Fugl-Meyer assessment (time frame: 3rd week, and 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.