Functional Outcome of Hemiplegic Upper Extremity in Patients With Subacute Stroke After Kinesiotaping and Rehabilitation

NCT ID: NCT04027985

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-02-05

Brief Summary

1. To explore the role of sonoelastography with shear wave velocity to assess poststroke spasticity of affected arm and forearm muscles in patients with stroke.

2. To investigate the effects of Kinesiotaping applications on motor recovery, functional performance, and spasticity of affected upper extremity in patients with subacute stroke.

Detailed Description

Clinical characteristics of impaired motor performance on affected upper extremity in stroke patients included muscle weakness, increased muscle tone, contracture, joint instability, or impaired motor control. Poststroke spasticity (PSS) is also a common complication in stroke patients with limbs weakness and impaired coordination between agonist and antagonist contraction. Upper extremity impairments and PSS have negative effects on functional performances and quality of daily livings. In patients with subacute stroke, strengthening exercises, constraint-induce movement therapy, mirror therapy, mental practice, and neuromuscular electrical stimulation, botulinum toxin, and antidepressants are recommended. For managing PSS, several therapeutic interventions include stretching and range of motion exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications, local injection with phenol or botulism, or surgery. Some investigators found that Kinesiotaping (KT) combined with other interventions may facilitate muscle function, provide joint support and proprioception feedback, and reduce pain in stroke patients with hemiplegia. The investigators will perform KT applications both on the proximal and distal parts of affected upper extremity to facilitate motor recovery and performance in subacute stroke patients with hemiplegia while receiving rehabilitation.

After reviewing literatures, sonoelastography and shear wave velocity (SWV) was applied to evaluate the muscle stiffness in stroke patients with upper limb spasticity, but mostly on biceps brachii muscle. The investigators try to use musculoskeletal sonography to explore the feasibility of sonoelastography as a quantitative tool for measuring PSS both on spastic arm and forearm muscles in patients with stroke.

In this study, sixty stroke patients with hemiplegia will be recruited for physical evaluations for PSS and functional performance of upper extremity, and sonoelastography with shear wave velocity (SWV) on biceps brachii, brachioradialis, flexor carpal radialis, and flexor carpal ulnaris muscles to explore the relationship between physical and sonographic assessements for PSS. In the next phase, 60 subacute patients with hemiplegia would be enrolled, then randomly divided into experimental or control groups. In experimental group (n=30), the patients will receive KT combined with rehabilitation once daily for five days, three weeks. In the control group (n=30), the patient will receive the same program without KT. All participants will receive following evaluations, including modified Ashworth and Tardieu scales, Fugl-Meyer Assessment for upper extremity, box and block test, the Wolf motor function test, and sonoelastography with shear wave velocity (SWV) before intervention, right after the three-week intervention, and three-week post intervention.

The aims of this study are:

1. To explore the role of sonoelastography with shear wave velocity to assess poststroke spasticity of affected arm and forearm muscles in patients with stroke.

2. To investigate the effects of Kinesiotaping applications on motor recovery, functional performance, and spasticity of affected upper extremity in patients with subacute stroke.

Conditions

Stroke; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

KT group

the patients will receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention.

Group Type: EXPERIMENTAL

Kinesiotaping

Intervention Type: OTHER

inesio 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.

Hand rehabilitation program

Intervention Type: OTHER

In the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period.

Control group

the patients will receive sham KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention.

Group Type: SHAM_COMPARATOR

Hand rehabilitation program

Intervention Type: OTHER

In the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period.

Sham taping

Intervention Type: OTHER

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.

Interventions

Kinesiotaping

inesio 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: OTHER

Hand rehabilitation program

In the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period.

Intervention Type: OTHER

Sham taping

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The patients have a stroke with hemiplegia (duration is 3-6 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 old or older than 80 years old;
• previous history of upper extremity tendon or neuromuscular injury;
• any other systemic neuromuscular disease; cognition or language impairment leading to communication difficulty.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuchi Huang

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

NMRPG8J0221

Identifier Type: -

Identifier Source: org_study_id