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

NCT04027985 | Completed

• 1 other identifier: NMRPG8J0221
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Keywords

Kinesiotaping; Spasticity; Elastosonography; Stroke

Outcome Measures

Primary Outcomes (3)

• the change from baseline to time of MAS scale

  a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Ashworth scale). In this scale, muscle tone would be assessed by quick stretch of muscle belly. The scoring criteria are as follows. 0, no increase in muscle tone; 1, Slight increase in muscle tone; 2, More marked increase in muscle tone through most of the ROM; 3, considerable increase in muscle tone; 4, affected part(s) rigid in flexion or extension.

  3rd week, and 6th week

• the change from baseline to time of Musculoskeletal sonography

  an experienced physiatrist will evaluate the findings on sonography, sonoelastography, and shear wave velocity (SWV). The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degrees 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 at follow up for each patient. The SWV will be done in the longitudinal/transverse planes 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.

  3rd week, and 6th week

• the change from baseline to time of Fugl-Meyer assessment for upper extremity

  a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance. The total score ranges from 0 to 66 for motor function.

  3rd week, and 6th week

Secondary Outcomes (7)

• 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

Study Arms (2)

KT group

EXPERIMENTAL

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.

Other: Kinesiotaping; Other: Hand rehabilitation program

Control group

SHAM COMPARATOR

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.

Other: Hand rehabilitation program; Other: Sham taping

Interventions

Kinesiotaping 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.

KT group

Hand rehabilitation program 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; KT group

Sham taping 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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Stroke; Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Yuchi Huang

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: November 1, 2019
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)