Clinical trial NCT03682666: Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke
Official title: The Clinical Effect and Sonographic Findings of Kinesiotaping and Constraint Induced Movement Therapy in Upper Extremity Function and Spasticity in Patients With Subacute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Kinesiotaping
constraint induced movement therapy
sonography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: the change from baseline to time of Fugl-Meyer assessment
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of Musculoskeletal sonography
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of MAS scale
timeFrame: 3rd week, and 6th week
Secondary outcomes:
measure: the change from baseline to time of Brunnstrom stage
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of modified Tardieu scale
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of existence of sensation
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of quality of life by Stroke Impact Scale
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of quality of life by Barthel Index
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of functional performance by box and block test
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of functional performance by STEF
timeFrame: 3rd week, and 6th week
measure: the change from baseline to time of functional performance by Wolf Motor Function Test
timeFrame: 3rd week, and 6th week
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Chi Huang, MD
role: STUDY_CHAIR
References: