- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06072261
The Effect of Handgrip Strength on Functional Level
The Effect of Handgrip Strength on Functional Level in Elderly People Having Lower Extremity Surgery
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Isparta
-
Merkez, Isparta, Turkey, 32000
- Menekşe ŞAFAK
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesio Tape Group
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
|
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
|
No Intervention: Control 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Handgrip strenght
Time Frame: 3-5 days (Change from Baseline Handgrip strenght at discharged)
|
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
Time Frame: 3-5 days (Change from Baseline Handgrip strenght at discharged)
|
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
Time Frame: 3-5 days (Change from Baseline Handgrip strenght at discharged)
|
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)
Time Frame: 3-5 days (Change from Baseline Handgrip strenght at discharged)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeliha BAŞKURT, Prof. Dr., Süleyman Demirel Üniversitesi
- Study Chair: Ferdi BAŞKURT, Prof. Dr., Süleyman Demirel Üniversitesi
- Study Chair: Tuba İNCE PARPUCU, Assist. Prof., Süleyman Demirel Üniversitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MS2023/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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