NCT06072261

Brief Summary

In this study, it was aimed to examine the effects of kinesio tape applied to the forearm extensor muscles on the functional level of patients undergoing lower extremity surgery with walker ambulation. Patients who were evaluated before being included in the post-surgical rehabilitation program (before kinesio tape application) and before discharge will be included in the study group. For the control group data, patients who underwent lower extremity surgery at the same institution for similar periods, but were included in the standard rehabilitation program, but did not apply kinesio tape, will be included. Standard rehabilitation practice includes in-bed transfer training, gait training, practice of daily living activities, and therapeutic exercise practices . Before the standard rehabilitation program, kinesio taping was applied to both upper extremities in the form of a "Y" tape from the medial epicondyle to the wrist flexors, with 15-20% tension, to the patients hospitalized in the orthopedic service after lower extremity surgery. The tape should remain on the patient's arm throughout the hospital stay

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 2, 2023

Last Update Submit

October 6, 2023

Conditions

Keywords

ElderlyFunctional LevelHandgrip StrenghtKinesio Tape

Outcome Measures

Primary Outcomes (4)

  • Handgrip strenght

    It was evaluated using a Jamar handheld dynamometer. During the evaluation, the patient was asked to stand in a static position. Maximum grip strength measurements were performed with the elbow flexed at 90° in the patient sitting position. Measurements were repeated 3 times at 30 second intervals in both extremities, and the results were recorded in kilogram-force form. In the measurement of maximum handgrip strength, the participants were asked to continue squeezing even if there was pain, and the maximum grip strength they reach was recorded

    3-5 days (Change from Baseline Handgrip strenght at discharged)

  • Pain assessment

    Visual Analogue Scale (VAS) was used for pain assessment. The pain of the patient, who determines a point on the vertically drawn line with a length of 10 cm, is determined over one hundred points. A score of 100 means unbearable pain, and a score of 0 means no pain at all. This evaluation provides information about the pain profile of patients during activity and at rest

    3-5 days (Change from Baseline Handgrip strenght at discharged)

  • Functional Independence Measurement-FIM

    The FIM instrument FIM indicates the degree of independence of the individual in basic physical and cognitive activities in daily life. The FIM includes 18 items that measure functional independence in 6 subscales: self-care, sphincter control, mobility, locomotion, communication, and social cognition. Each item is rated on a seven-point scale that represents different gradations of independence and reflects the amount of assistance the patient requires to perform a specific activity. Independence is categorized and scored as complete independence, 7; modified independence, 6; requires supervision or setup, 5; requires minimal contact assistance, 4; requires moderate assistance, 3; requires maximal assistance, 2; and requires total assistance, 1. The sum of all 18 items comprises the patient's total FIM score, which ranges from 18 to 126

    3-5 days (Change from Baseline Handgrip strenght at discharged)

  • Iowa Level of Assistance Scale (ILAS) and Walking Speed Scale (IWSS)

    ILAS and IWSS are a measurement method that evaluates various physical functions and whose validity and reliability have been demonstrated in patients with knee replacement. With the ILAS, the performance level of 4 different physical activities (from lying on the back to sitting, getting up from sitting, walking 4.57 meters (15 feet), going up and down three flights of stairs) is evaluated. The scoring of these physical activities is based on the level of assistance that patients need during the activities ("0" could not be tested, "1" unsuccessful, "2" maximum assistance, "3" medium assistance, "4" minimum assistance, "5" observational assistance, "5" observational assistance. 6" independent) are made. With IWSS, walking speed is evaluated at a distance of 13.4 meters (44 feet). This scale ranges from 0 to 6 ("0" ≤20 sec, "1" 21-30 sec, "2" 31-40 sec, "3" 41-50 sec, "4" 51-60 sec, "5" 61 -70 sec, "6" \>70 sec) or the time to complete walking is recorded as a score.

    3-5 days (Change from Baseline Handgrip strenght at discharged)

Study Arms (2)

Kinesio Tape Group

EXPERIMENTAL

Before the standard rehabilitation program, kinesio taping was applied to both upper extremities in the form of a "Y" tape from the medial epicondyle to the wrist flexors, with 15-20% tension, to the patients hospitalized in the orthopedic service after lower extremity surgery. The tape should remain on the patient's arm throughout the hospital stay

Other: kinesio tape application

Control Group

NO INTERVENTION

For the control group data, patients who underwent lower extremity surgery at the same institution for similar periods, but were included in the standard rehabilitation program, but did not apply kinesio tape, will be included. Standard rehabilitation practice includes in-bed transfer training, gait training, practice of daily living activities, and therapeutic exercise practices

Interventions

Before the standard rehabilitation program, kinesio taping was applied to both upper extremities in the form of a "Y" tape from the medial epicondyle to the wrist flexors, with 15-20% tension, to the patients hospitalized in the orthopedic service after lower extremity surgery. The tape should remain on the patient's arm throughout the hospital stay

Kinesio Tape Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients over 65 years of age of both sexes, patients who were followed up postoperatively in the Department of Orthopedics of Süleyman Demirel University, patients whose mobilization was provided with a walker, and patients whose general condition was oriented and cooperative, were included in the study

You may not qualify if:

  • Patients with uncontrollable lung or cardiac problems, patients with psychiatric disease (dementia…) that may affect the answers given, patients who used any drugs and alcohol that could affect cognitive functions were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menekşe ŞAFAK

Merkez, Isparta, 32000, Turkey (Türkiye)

Location

Study Officials

  • Zeliha BAŞKURT, Prof. Dr.

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR
  • Ferdi BAŞKURT, Prof. Dr.

    Suleyman Demirel University

    STUDY CHAIR
  • Tuba İNCE PARPUCU, Assist. Prof.

    Suleyman Demirel University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

April 15, 2023

Primary Completion

August 1, 2023

Study Completion

September 15, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations