Clinical trial NCT04027985: Functional Outcome of Hemiplegic Upper Extremity in Patients With Subacute Stroke After Kinesiotaping and Rehabilitation
Official title: The Functional Outcome of Hemiplegic Upper Extremity in Patients With Subacute Stroke After Kinesiotaping Combined With Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Keywords: Kinesiotaping
Spasticity
Elastosonography
Stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

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 with subacute stroke.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the change from baseline to time of MAS scale
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of Musculoskeletal sonography
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of Fugl-Meyer assessment for upper extremity
timeFrame: 3rd week, and 6th week
Secondary outcomes:
measure: the change from baseline to time of Brunnstrom stage
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of modified Tardieu scale
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of existence of sensation
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of quality of life by Stroke Impact Scale
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of quality of life by Barthel Index
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of functional performance by box and block test
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of functional performance by STEF
timeFrame: 3rd week, and 6th week
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yuchi Huang
role: STUDY_CHAIR
References: