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

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ClinicalTrials.gov Identifier: NCT03024190
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Stroke Upper Extremity Spasticity Other: Kinesiotaping Other: stretching exercise Other: OT rehabilitation program Not Applicable

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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Clinical Effect and Sonographic Findings of Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024190


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yu Chi Huang, Bachelor Chang Gung Memorial Hospital

Publications:

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03024190     History of Changes
Other Study ID Numbers: CMRPG8F1101
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Keywords provided by Chang Gung Memorial Hospital:
stroke
spasticity
Kinesiotaping
sonography
exercise

Additional relevant MeSH terms:
Stroke
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms