Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients

Not Applicable

Completed

• Conditions: Stroke; Upper Extremity Spasticity
• Interventions: Other: Kinesiotaping; Other: stretching exercise; Other: OT rehabilitation program

• Registration Number: NCT03024190
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-27
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with Kinesiotaping	OT rehabilitation program	* stretching exercises combined with Kinesiotaping * regular OT rehabilitation program for 3 weeks
control group	OT rehabilitation program	* the patients will receive 15-min stretching exercises * regular OT rehabilitation program for 3 weeks
with Kinesiotaping	stretching exercise	* stretching exercises combined with Kinesiotaping * regular OT rehabilitation program for 3 weeks
control group	stretching exercise	* the patients will receive 15-min stretching exercises * regular OT rehabilitation program for 3 weeks
with Kinesiotaping	Kinesiotaping	* stretching exercises combined with Kinesiotaping * regular OT rehabilitation program for 3 weeks

Primary Outcome Measures

Name	Time	Method
Modified Ashworth scale for level of spasticity of affected arm	baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.	A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.
Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function	baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.	A physical therapist will use Fugl-Meyer assessment for upper extremity (FMA-UE) to evaluate patient's hand function and analyze the changes on the score of it from baseline till third week and fifth week.

Secondary Outcome Measures

Name	Time	Method
Modified Tardieu scale for level of spasticity of affected arm	baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.	A physical therapist will measure the level of spasticity in affected arm by using modified Tardieu scale.
Brunnstrom motor recovery stage for motor ability	baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.	A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till third week and fifth week.
the change from baseline on hemiplegic upper extremity sonography	baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.	for the flexor carpal ulnaris (FCU), flexor carpal radialis (FCR), and flexor digitorum superficialis (FDS) muscles.; The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degree 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 after intervention for each patient. The SWV will be done in the transverse plane 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.