StrokeNCT04027985
Functional Outcome of Hemiplegic Upper Extremity in Patients With Subacute Stroke After Kinesiotaping and Rehabilitation
A study testing Kinesiotaping and Hand rehabilitation program in people with Stroke and Hemiplegia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
1. To explore the role of sonoelastography with shear wave velocity to assess poststroke spasticity of affected arm and forearm muscles in patients with stroke. 2. To investigate the effects of Kinesiotaping applications on motor recovery, functional performance, and spasticity of affected upper extremity in patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Kinesiotaping and Hand rehabilitation program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2019to 5 Feb 2021
- 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 3-6 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 old or older than 80 years old;
- previous history of upper extremity tendon or neuromuscular injury;
- any other systemic neuromuscular disease; cognition or language impairment leading to communication difficulty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Functional Outcome of Hemiplegic Upper Extremity in Patients With Subacute Stroke After Kinesiotaping Combined With Rehabilitation
- To explore the role of sonoelastography with shear wave velocity to assess poststroke spasticity of affected arm and forearm muscles in patients with stroke.
- To investigate the effects of Kinesiotaping applications on motor recovery, functional performance, and spasticity of affected upper extremity in patients with subacute stroke.
Read the detailed description
Clinical characteristics of impaired motor performance on affected upper extremity in stroke patients included muscle weakness, increased muscle tone, contracture, joint instability, or impaired motor control. Poststroke spasticity (PSS) is also a common complication in stroke patients with limbs weakness and impaired coordination between agonist and antagonist contraction. Upper extremity impairments and PSS have negative effects on functional performances and quality of daily livings. In patients with subacute stroke, strengthening exercises, constraint-induce movement therapy, mirror therapy, mental practice, and neuromuscular electrical stimulation, botulinum toxin, and antidepressants are recommended. For managing PSS, several therapeutic interventions include stretching and range of motion exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications, local injection with phenol or botulism, or surgery. Some investigators found that Kinesiotaping (KT) combined with other interventions may facilitate muscle function, provide joint support and proprioception feedback, and reduce pain in stroke patients with hemiplegia. The investigators will perform KT applications both on the proximal and distal parts of affected upper extremity to facilitate motor recovery and performance in subacute stroke patients with hemiplegia while receiving rehabilitation.
After reviewing literatures, sonoelastography and shear wave velocity (SWV) was applied to evaluate the muscle stiffness in stroke patients with upper limb spasticity, but mostly on biceps brachii muscle. The investigators try to use musculoskeletal sonography to explore the feasibility of sonoelastography as a quantitative tool for measuring PSS both on spastic arm and forearm muscles in patients with stroke.
In this study, sixty stroke patients with hemiplegia will be recruited for physical evaluations for PSS and functional performance of upper extremity, and sonoelastography with shear wave velocity (SWV) on biceps brachii, brachioradialis, flexor carpal radialis, and flexor carpal ulnaris muscles to explore the relationship between physical and sonographic assessements for PSS. In the next phase, 60 subacute patients with hemiplegia would be enrolled, then randomly divided into experimental or control groups. In experimental group (n=30), the patients will receive KT combined with rehabilitation once daily for five days, three weeks. In the control group (n=30), the patient will receive the same program without KT. All participants will receive following evaluations, including modified Ashworth and Tardieu scales, Fugl-Meyer Assessment for upper extremity, box and block test, the Wolf motor function test, and sonoelastography with shear wave velocity (SWV) before intervention, right after the three-week intervention, and three-week post intervention.
The aims of this study are:
- To explore the role of sonoelastography with shear wave velocity to assess poststroke spasticity of affected arm and forearm muscles in patients with stroke.
- To investigate the effects of Kinesiotaping applications on motor recovery, functional performance, and spasticity of affected upper extremity in patients with subacute stroke.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Kinesiotaping, Hand rehabilitation program, Sham taping
- Keywords
- Kinesiotaping, Spasticity, Elastosonography, Stroke
- Medical subject headings
- Stroke, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
inesio 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.
Hand rehabilitation programOther
In the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period.
Sham tapingOther
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 | Experimental | the patients will receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. Receives: Other: Kinesiotaping; Other: Hand rehabilitation program |
| Control group | Sham comparator | the patients will receive sham KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. Receives: Other: Hand rehabilitation program; Other: Sham taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 Fugl-Meyer assessment for upper extremity
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 total score ranges from 0 to 66 for motor function.
Measured: 3rd week, and 6th week
Secondary outcomes (7)
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. The total score is from 0 to 100 for self-assessing the level of recovery.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Nov 2019
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuchi Huang, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027985
- Sponsor's protocol ID
- NMRPG8J0221
- Status last verified
- Jan 2021
- First submitted
- 18 Jul 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Outcome of Hemiplegic Upper Extremity in Patients With Subacute Stroke After Kinesiotaping Combined With Rehabilitation
- ClinicalTrials.gov ID
- NCT04027985
- Acronym / sponsor ID
- NMRPG8J0221
- Conditions
- Stroke, Hemiplegia
- Keywords
- Kinesiotaping, Spasticity, Elastosonography, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 22 Jul 2019 (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.
- To explore the role of sonoelastography with shear wave velocity to assess poststroke spasticity of affected arm and forearm muscles in patients with stroke.
- To investigate the effects of Kinesiotaping applications on motor recovery, functional performance, and spasticity of affected upper extremity in patients with subacute stroke.
Detailed description
Clinical characteristics of impaired motor performance on affected upper extremity in stroke patients included muscle weakness, increased muscle tone, contracture, joint instability, or impaired motor control. Poststroke spasticity (PSS) is also a common complication in stroke patients with limbs weakness and impaired coordination between agonist and antagonist contraction. Upper extremity impairments and PSS have negative effects on functional performances and quality of daily livings. In patients with subacute stroke, strengthening exercises, constraint-induce movement therapy, mirror therapy, mental practice, and neuromuscular electrical stimulation, botulinum toxin, and antidepressants are recommended. For managing PSS, several therapeutic interventions include stretching and range of motion exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications, local injection with phenol or botulism, or surgery. Some investigators found that Kinesiotaping (KT) combined with other interventions may facilitate muscle function, provide joint support and proprioception feedback, and reduce pain in stroke patients with hemiplegia. The investigators will perform KT applications both on the proximal and distal parts of affected upper extremity to facilitate motor recovery and performance in subacute stroke patients with hemiplegia while receiving rehabilitation.
After reviewing literatures, sonoelastography and shear wave velocity (SWV) was applied to evaluate the muscle stiffness in stroke patients with upper limb spasticity, but mostly on biceps brachii muscle. The investigators try to use musculoskeletal sonography to explore the feasibility of sonoelastography as a quantitative tool for measuring PSS both on spastic arm and forearm muscles in patients with stroke.
In this study, sixty stroke patients with hemiplegia will be recruited for physical evaluations for PSS and functional performance of upper extremity, and sonoelastography with shear wave velocity (SWV) on biceps brachii, brachioradialis, flexor carpal radialis, and flexor carpal ulnaris muscles to explore the relationship between physical and sonographic assessements for PSS. In the next phase, 60 subacute patients with hemiplegia would be enrolled, then randomly divided into experimental or control groups. In experimental group (n=30), the patients will receive KT combined with rehabilitation once daily for five days, three weeks. In the control group (n=30), the patient will receive the same program without KT. All participants will receive following evaluations, including modified Ashworth and Tardieu scales, Fugl-Meyer Assessment for upper extremity, box and block test, the Wolf motor function test, and sonoelastography with shear wave velocity (SWV) before intervention, right after the three-week intervention, and three-week post intervention.
The aims of this study are:
- To explore the role of sonoelastography with shear wave velocity to assess poststroke spasticity of affected arm and forearm muscles in patients with stroke.
- To investigate the effects of Kinesiotaping applications on motor recovery, functional performance, and spasticity of affected upper extremity in patients with subacute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KT group | Experimental | Other: Kinesiotaping, Other: Hand rehabilitation programthe patients will receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. |
| Control group | Sham comparator | Other: Hand rehabilitation program, Other: Sham tapingthe patients will receive sham KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. |
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 3-6 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 (3 listed)
- age is younger than 18 years old or older than 80 years old;
- previous history of upper extremity tendon or neuromuscular injury;
- any other systemic neuromuscular disease; cognition or language impairment leading to communication difficulty.
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 |
|---|---|---|
| Kinesiotapinginesio 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. | Other | KT group |
| Hand rehabilitation programIn the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period. | Other | Control group, KT 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. | Other | Control group |
Primary outcome
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.
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 Fugl-Meyer assessment for upper extremity
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 total score ranges from 0 to 66 for motor function.
7 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
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 29 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Yuchi Huang 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 Hand rehabilitation program in people with Stroke and Hemiplegia, 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 3 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 29 Jul 2021. 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 MAS scale (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 29 Jul 2021.