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

Stroke Clinical Trial

Official title:

The Clinical Effect and Sonographic Findings of Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024190
• Other study ID #: CMRPG8F1101
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2018

Study information

• Verified date: December 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke
• Upper Extremity Spasticity

Intervention

Other:
• Kinesiotaping
The technique of Kinesiotaping for spastic wrists and fingers in stroke patients is 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.
• stretching exercise
15- min stretching exercise for upper extremity twice daily
• OT rehabilitation program
regular rehabilitation program for 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function	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.	baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.
Primary	Modified Ashworth scale for level of spasticity of affected arm	A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.	baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
Secondary	the change from baseline on hemiplegic upper extremity sonography	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.	baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.
Secondary	Brunnstrom motor recovery stage for motor ability	A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till third week and fifth week.	baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.
Secondary	Modified Tardieu scale for level of spasticity of affected arm	A physical therapist will measure the level of spasticity in affected arm by using modified Tardieu scale.	baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.