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

September 21, 2018 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with Kinesiotaping
  • stretching exercises combined with Kinesiotaping
  • regular OT rehabilitation program for 3 weeks
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.
Other: stretching exercise
15- min stretching exercise for upper extremity twice daily
Other: OT rehabilitation program
regular rehabilitation program for 3 weeks
Other: control group
  • the patients will receive 15-min stretching exercises
  • regular OT rehabilitation program for 3 weeks
Other: stretching exercise
15- min stretching exercise for upper extremity twice daily
Other: OT rehabilitation program
regular rehabilitation program for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.
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.
baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change from baseline on hemiplegic upper extremity sonography
Time Frame: 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.
baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.
Brunnstrom motor recovery stage for motor ability
Time Frame: 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.
baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.
Modified Tardieu 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 Tardieu scale.
baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8F1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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