The Clinical Effect and Sonographic Findings of Kinesiotaping and Constraint Induced Movement Therapy in Upper Extremity Function and Spasticity in Patients With Subacute Stroke

Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke

Sponsors

Lead sponsor: Chang Gung Memorial Hospital

Source Chang Gung Memorial Hospital
Brief Summary

In stroke patients, the most common neurological deficits were motor impairment, loss of somatosensation, abnormal muscle tone, and impaired fractionated movement at affected limbs. Therefore, the investigators try to facilitate upper extremity function and normalize the muscle tone to enlarge their capacity to perform daily activities and to improve life quality by modified constraint-induced movement therapy (mCIMT) and Kinesiotaping (KT).

The investigators will collect 90 subacute stroke patients with hemiplegia in this study. These 90 patients will be randomly divided into 3 groups. In KT group (n=30), the patients will perform Kinesiology taping for 5 days per week for 3 weeks. In mCIMT group (n=30), the patient will receive constraint the unaffected limb for 2 hours a day, 5 days a week for three weeks. In KT+mCIMT group, the KT and mCIMT interventions would be performed for 5 days a week in three weeks. All the patients in KT, CIMT and KT+mCIMT groups will receive 20-minute hand function training twice daily for 5 days per week for 3 weeks. Before intervention, immediately and 3 week later after intervention, all patients will receive the physical examinations including motor recovery stage (Brunnstrom stage), spasticity (modified Ashworth scale and Tardieu scale), and sensation. Fugl-Meyer assessment for upper extremity (FMA-UE), box and block test, Simple Test for Evaluating Hand Function (STEF), and Wolf Motor Function Test for hand function, ADL and quality of life assessment and musculoskeletal sonography for affected forearms will be also evaluated in this study.

The aims of this study are:

1. To investigate the effect of Kinesiotaping and modified CIMT in improving upper extremity function and spasticity for subacute stroke patients with hemiplegia.

2. To explore the role of sonoelastography and shear wave velocity in poststroke spasticity assessment.

Overall Status Completed
Start Date October 1, 2018
Completion Date December 10, 2019
Primary Completion Date November 6, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the change from baseline to time of Fugl-Meyer assessment 3rd week, and 6th week
the change from baseline to time of Musculoskeletal sonography 3rd week, and 6th week
the change from baseline to time of MAS scale 3rd week, and 6th week
Secondary Outcome
Measure Time Frame
the change from baseline to time of Brunnstrom stage 3rd week, and 6th week
the change from baseline to time of modified Tardieu scale 3rd week, and 6th week
the change from baseline to time of existence of sensation 3rd week, and 6th week
the change from baseline to time of quality of life by Stroke Impact Scale 3rd week, and 6th week
the change from baseline to time of quality of life by Barthel Index 3rd week, and 6th week
the change from baseline to time of functional performance by box and block test 3rd week, and 6th week
the change from baseline to time of functional performance by STEF 3rd week, and 6th week
the change from baseline to time of functional performance by Wolf Motor Function Test 3rd week, and 6th week
Enrollment 35
Condition
Intervention

Intervention type: Device

Intervention name: Kinesiotaping

Description: Kinesio tape would be applied over the extensor muscles of the affected hand for facilitating the extension of hand. We will apply the tape from the upper 1/3 length of dorsal side of the forearm and split the tape into five equal bars to the distal interphalangeal joint of each finger along the finger bones. This intervention would be executed for five days per week for three weeks.

Intervention type: Behavioral

Intervention name: modified Constraint Induced Movement Training

Description: A 2-hour time period would be arranged to constraint patient's unaffected hand by using a bandage by a therapist. During this two hours, patients would not be allowed to use this unaffected to do any activity, so that they will need to use the affected hand. The caregivers would also be educated to provide less help if it is not necessary. This intervention would be executed two hours a day for five days per week, for three weeks.

Intervention type: Device

Intervention name: Sham taping

Description: A short piece of kinesio tape would be cut into half and applied over the lateral side of the forearm from the lateral epicondyle till the half of the forearm. The tape would not cover the both the flexor and extensor muscle bellies.

Arm group label: mCIMT group

Eligibility

Criteria:

Inclusion Criteria:

- The patients have a stroke with hemiplegia (duration is 3~12 months after stroke).

- Patients who are able to perform hand grasp.

- Patients who could slightly do fingers extension and minimal wrist extension. (ability of extension at least 10 degrees at the metacarpophalangeal and interphalangeal joints and 20 degrees at the wrist.)

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

- allergy history when application of KT materials

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Yu-Chi Huang, MD Study Chair Chang Gung Memorial Hospital
Location
facility
Kaohsiung Chang Gung Memorial Hospital
Location Countries

Taiwan

Verification Date

September 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: KT group

Arm group type: Active Comparator

Description: the patients will perform Kinesiotaping for 5 days per week for 3 weeks

Arm group label: mCIMT group

Arm group type: Sham Comparator

Description: the unaffected limb will be constraint for 2 hours a day, 5 days a week for three weeks. And they will receive sham taping on the affected limb.

Arm group label: KT+mCIMT group

Arm group type: Experimental

Description: the patients will perform Kinesiology taping for 5 days per week for 3 weeks, and while being taped, the modified Constraint Induced Movement Training would be also executed.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov