Complex Decongestive Therapy on Distal Radius Fracture
Tylko zarejestrowani użytkownicy mogą tłumaczyć artykuły
Zaloguj się Zarejestruj się
Link zostanie zapisany w schowku
StatusRekrutacyjny
Sponsorzy
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
BADANIE KLINICZNE: NCT04484584
BioSeek: nct04484584
Słowa kluczowe
Abstrakcyjny
Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged exudation period create a physiological problem. It causes the recovery time of tissues to be completed late and the functional gains to be delayed.
The aim of the study is to investigate the effect of Complex decongestive therapy on traumatic edema, pain and functionality.
Opis
Patients are composed of patients who are referred to the physical medicine and rehabilitation clinic. All patients eligible for the study were informed about treatment and possible risks, and a consent form was signed. Determined evaluations were made to the patients. After 3 weeks of treatment, patients will be invited to the controls and the long-term effects of the treatments will be investigated.
Patients with a diameter difference of more than 50 ml between two extremities and patients without Sudeck Atrophy will be included in the treatment.
The study was planned as a single blind with randomized control. The physiotherapist who performed the treatment received manual lymph drainage therapy training.
The patients were distributed to groups with a computer-based data distribution system. While the patients are sent for treatment, they are directed according to the first assessment. The person who performed the assessment and those who received treatment were planned differently.
The primary purpose of the study was to investigate the long-term effectiveness of complex decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions. Other objectives are to investigate the long-term effects on range of motion, muscle strength, grip strength, pain, and daily living activities.
Daktyle
| Ostatnia weryfikacja: | 06/30/2020 |
| Pierwsze przesłane: | 07/08/2020 |
| Szacowana liczba przesłanych rejestracji: | 07/21/2020 |
| Wysłany pierwszy: | 07/22/2020 |
| Ostatnia aktualizacja przesłana: | 07/21/2020 |
| Ostatnia opublikowana aktualizacja: | 07/22/2020 |
| Rzeczywista data rozpoczęcia badania: | 03/16/2020 |
| Szacowana data zakończenia podstawowej działalności: | 06/30/2021 |
| Szacowana data zakończenia badania: | 06/30/2021 |
Stan lub choroba
Distal Radius Fracture
Interwencja / leczenie
Other: complex decongestive therapy
Faza
-
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Complex Decongestive Therapy Group (CDT) Complex Decongestive Therapy Group: The treatment was applied by a specialist therapist who received CDT training. The study group rehabilitation and CDT application is 1 hour. CDT Treatment Protocol:
Deep abdominal technique application Neck region CDT application (supraclavicular fossa circular motion-Eflöraj) Circular movements on ipsilateral Axillar lymph nodes Circular movements on bottle neck cubital fossa Front arm bucket pumping pump push MLD application of dorsal and palmar face of the hand to ulnar and radial bundles
Bandage Treatment (Fingers and hand and forearm bandage): Patients can stay for 6-8 hours or until the next day.
Patients can do exercises in bandages. The patient is given home education.
The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic rehabilitation is the same as the control group. | |
| Orthopedic Rehabilitation Group (OR) Orthopedic Rehabilitation Group: The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home.
Orthopedic Rehabilitation Treatment Protocol:
Exercises to be done at 4 to 6 weeks: Wrist NEH (at the pain limit),active exercise,Grasp exercise
Exercises to be done at 6 to 8 weeks: Wrist NEH (at the pain limit),Active assistive / active exercise, Grasp exercise,Supination-pronation exercise. (Opposite baths and classical massage are recommended from orthopedics)
Exercises to be done at 8 to 10 weeks: Stretching exercises,Finger strengthening spring with Digiflex spring, Power web combo hand finger arm amplifier, Msd theraflex hand exercise dough, Theraband flevbar exercise bar.
Exercises to be done at 10 to 12 weeks Wrist strengthening exercises, Resistant exercises to all muscles. |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 45 Years Do 45 Years |
| Płeć kwalifikująca się do nauki | All |
| Metoda próbkowania | Probability Sample |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - Over 45 years - Unilateral distal radius fracture treated with plaster cast - Begin treatment after (7-10) days after removing the plaster - At least 50 mL of the volume difference between the upper extremities - Having signed the consent form Exclusion Criteria: - Associated ulna fracture - Pathological fracture - polytrauma - Bilateral fractures - With chronic kidney disease - The presence of infection |
Wynik
Podstawowe miary wyników
1. Volumetric test measurement [1. week]
Volumetric test measurement is more than 50 mL, edema is considered to be present.
2. Volumetric test measurement [3. week]
Volumetric test measurement is more than 50 mL, edema is considered to be present.
3. Volumetric test measurement [6. week]
Volumetric test measurement is more than 50 mL, edema is considered to be present.
4. Volumetric test measurement [12. week]
Volumetric test measurement is more than 50 mL, edema is considered to be present.
5. Michigan Hand Outcomes Questionnarie [1. week]
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
6. Michigan Hand Outcomes Questionnarie [3. week]
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
7. Michigan Hand Outcomes Questionnarie [6. week]
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
8. Michigan Hand Outcomes Questionnarie [12. week]
The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
9. Myometer test [1. week]
Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
10. Myometer test [3. week]
Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
11. Myometer test [6. week]
Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
12. Myometer test [12. week]
Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
13. Dynamometer test [1.week]
A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
14. Dynamometer test [3.week]
A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
15. Dynamometer test [6.week]
A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
16. Dynamometer test [12.week]
A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
Miary wyników wtórnych
1. Nine hole peg test [1. week]
nine hole peg test is a test for manual performance that evaluates problems in the peripheral and central nervous system. The average second in the right hand for men should be 18.99 - left hand 19.79, and the right hand in women 17.67 - left hand should be 18.91.
2. Nine hole peg test [3. week]
nine hole peg test is a test for manual performance that evaluates problems in the peripheral and central nervous system. The average second in the right hand for men should be 18.99 - left hand 19.79, and the right hand in women 17.67 - left hand should be 18.91.
3. Nine hole peg test [6. week]
nine hole peg test is a test for manual performance that evaluates problems in the peripheral and central nervous system. The average second in the right hand for men should be 18.99 - left hand 19.79, and the right hand in women 17.67 - left hand should be 18.91.
4. Nine hole peg test [12. week]
nine hole peg test is a test for manual performance that evaluates problems in the peripheral and central nervous system. The average second in the right hand for men should be 18.99 - left hand 19.79, and the right hand in women 17.67 - left hand should be 18.91.
5. Patient Rated Wrist Evaluation [1. week]
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
6. Patient Rated Wrist Evaluation [3. week]
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
7. Patient Rated Wrist Evaluation [6. week]
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
8. Patient Rated Wrist Evaluation [12. week]
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
9. Quick DASH [1. week]
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
10. Quick DASH [3. week]
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
11. Quick DASH [6. week]
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
12. Quick DASH [12. week]
Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
13. İnclinometer measurement [1. week]
Range of motion is the range through which a joint can be moved at Physical exam. Range of motion is measured by your physical therapist using a device called a inclinometer. accepted ranges for the wrist; flexion 90, extension 70-90, radial deviation 20, ulnar deviation 30-50 degrees.
14. İnclinometer measurement [3. week]
Range of motion is the range through which a joint can be moved at Physical exam. Range of motion is measured by your physical therapist using a device called a inclinometer. accepted ranges for the wrist; flexion 90, extension 70-90, radial deviation 20, ulnar deviation 30-50 degrees.
15. İnclinometer measurement [6. week]
Range of motion is the range through which a joint can be moved at Physical exam. Range of motion is measured by your physical therapist using a device called a inclinometer. accepted ranges for the wrist; flexion 90, extension 70-90, radial deviation 20, ulnar deviation 30-50 degrees.
16. İnclinometer measurement [12. week]
Range of motion is the range through which a joint can be moved at Physical exam.Range of motion is measured by your physical therapist using a device called a inclinometer. accepted ranges for the wrist; flexion 90, extension 70-90, radial deviation 20, ulnar deviation 30-50 degrees.
