Clinical trial NCT03024190: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Spasticity
Keywords: stroke
spasticity
Kinesiotaping
sonography
exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 36
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: 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.

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

Primary outcomes:
measure: Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function
timeFrame: baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.
measure: Modified Ashworth scale for level of spasticity of affected arm
timeFrame: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
Secondary outcomes:
measure: the change from baseline on hemiplegic upper extremity sonography
timeFrame: baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.
measure: Brunnstrom motor recovery stage for motor ability
timeFrame: baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.
measure: Modified Tardieu scale for level of spasticity of affected arm
timeFrame: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu Chi Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
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