Skip to main content
Clinical Trials/NCT03024190
NCT03024190
Completed
Not Applicable

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

Chang Gung Memorial Hospital0 sites36 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Chang Gung Memorial Hospital
Enrollment
36
Primary Endpoint
Modified Ashworth scale for level of spasticity of affected arm
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Modified Ashworth scale for level of spasticity of affected arm

Time Frame: 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

Time Frame: 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 Outcomes

  • 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.)
  • Brunnstrom motor recovery stage for motor ability(baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.)
  • the change from baseline on hemiplegic upper extremity sonography(baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.)

Similar Trials