Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Tendon Injury

Study Overview
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Brief Summary
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The aim of our study is to determine the effect of activity-based intervention on the activity, participation levels and kinesiophobia (fear of movement) of the patients by evaluating the person, environment and activity using the Person-Environment-Occupation model (PEO) in the rehabilitation of hand forearm flexor tendon injuries.

Detailed Description
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Our study will be carried out on housewives who were operated by Pamukkale University Education, Application and Research Center Directorate Orthopedics and Traumatology and Plastic, Reconstructive and Aesthetic Surgery Services due to flexor tendon injury in the forearm or hand. Patients will be evaluated at the 7th, 12th and 24th weeks post-operatively, before the start of the post-operative physiotherapy program. The data obtained from the study will be analyzed with the PASW Statistics 18 Release 18.0.0 program. Whether the data fit the normal distribution will be determined using the Shapiro-Wilk test. If parametric conditions are not met, Wilcoxon Signed Rank Test and Friedman Analysis of Variance will be used for intragroup comparisons, and Mann-Whitney U Test will be used for intergroup comparisons. Statistical significance level will be taken as p<0.05. The physiotherapy program will start the post-operative first week for both group. Activity-based therapy group will have activity exercises that is meaningful for the patients, once a week one hour addition to the physiotherapy. Patients to be included in groups were randomized in a single block order using Random Allocation Software 1.0.0.

Official Title
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Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Flexor Tendon Injury

Conditions
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Flexor Tendon Rupture

Intervention / Treatment
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* Other: physiotherapy
* Other: activity-based therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those between the ages of 18-65 flexor tendon injury Primary tendon repair performed a woman Exclusion Criteria: Presence of major nerve injury (radial, ulnar, median nerve) Presence of concomitant injuries (fracture, joint injury, ligament injury) Presence of any previous or ongoing orthopedic, neurological, rheumatological and metabolic disease or disorder in the relevant extremity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised-controlled trial group 1 (get only physiotherapy) After flexor tendon repair patients start getting physiotherapy. They use static dorsal splint. exercises are progressive according to the healing process. Physiotherapy lasts 12 weeks. then follow-up sixth months. group 2 (get both physiotherapy and activity-based therapy) After flexor tendon repair patients start getting physiotherapy. They use static dorsal splint. exercises are progressive according to the healing process. Physiotherapy lasts 12 weeks. then follow-up sixth months. Additionally group 2 gets activity-based therapy once a week about an hour. activities are also progressive according to the patients needs.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>group 1 (get only physiotherapy) After flexor tendon repair patients start getting physiotherapy. They use static dorsal splint. exercises are progressive according to the healing process. Physiotherapy lasts 12 weeks. Then follow-up sixth months. | Other: physiotherapy<br>* Patients get physiotherapy intervention after the surgery. exercises are progressive. sessions start passive range of motion exercises for 5 weeks while they are using a static dorsal splint. then splints are removed and patients start active range of motion exercises. and exercises progress to blocking, tendon gliding and resistive exercises.<br>|
| Experimental: group 2<br>group 2 (get both physiotherapy and activity-based therapy) After flexor tendon repair patients start getting physiotherapy. They use a static dorsal splint. Exercises are progressive according to the healing process. Physiotherapy lasts 12 weeks. then follow-up sixth month. Additionally, group 2 gets activity-based therapy once a week about an hour. activities are also progressive according to the patients needs. | Other: physiotherapy<br>* Patients get physiotherapy intervention after the surgery. exercises are progressive. sessions start passive range of motion exercises for 5 weeks while they are using a static dorsal splint. then splints are removed and patients start active range of motion exercises. and exercises progress to blocking, tendon gliding and resistive exercises.<br>Other: activity-based therapy<br>* patients get from the seventh week to the twelfth week an activity-based therapy. Activities are diverse according to the patient's needs. activities have therapeutic efficacy for improving range of motion, tendon gliding and strength.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Canadian occupational performance measure | The Canadian occupational performance measure, was used to determine the effect of the intervention on the participant's self-determined occupational performance goals. A scale of one to ten was used, where ten was the most important goal needed to be attained by the participants. Using the same scale, the participants were asked to rate the performance of the occupations and satisfaction with their performance. Both the sum of performance and satisfaction scores were divided by the number of identified problems to compute the overall score for analysis. | six month | 
| Tampa Kinesiophobia Scale | It is a 17-item scale developed to measure fear of movement and/or (re) injury. A high score indicates a high level of kinesiophobia. A score of <37 indicates low kinesiophobia, and a score≥37 indicates a high level of kinesiophobia. | six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| jebsen taylor hand function test | Jebsen Taylor Hand Function Test: It has 7 subtasks: writing, turning cards, collecting small objects, eating, placing chips, moving empty and full boxes. The test will begin with the non-dominant hand and both hands will be evaluated. | six month | 
| Michigan Hand Outcome Questionnaire: | It is a hand injury-specific questionnaire developed to measure outcomes for patients with all types of hand disorders.It is a self-filled questionnaire consisting of 6 sections and 57 questions. Scoring ranges from 0-100, with a higher score indicating better condition excluding pain. | six month | 
| grip strength | Pinch Grip Strength: It will be made with three different measurements. Grip strength, Pinch grip, Lateral grip, Triple grip strength: measurements will be made by squeezing the pinch meter between the palmar surface of the thumb, index and middle fingers. 3 repetitions will be done and the average will be recorded. A one-minute rest period will be given between repetitions. | 6 month | 
| range of motion | Metacarpophalangeal, proximal interphalangeal, distal interphalangeal joint flexion-extension, wrist flexion-extension, radial-ulnar deviation movements of the affected finger and finger in the intact extremity will be evaluated with a goniometer. Buck Gramcko will be used to score joint range of motion. Makes a score using the pulp-palm distance, combined flexion and extension deficit. There are 2 different scoring systems to be used separately for long fingers and thumb. Classification according to scores; 14-15 points perfect 11-13 points good 7-10 points satisfactory 0-6 points bad | six month | 
| Visual Analog Scale | Visual Analog Scale (VAS): 0 denotes when there is no pain, and 10 denotes the most severe pain level perceived. Patients will be asked to mark the intensity of pain they feel during activity, rest and at night on a 10 cm vertical line, and then the pain intensity will be determined by measuring the distance on the line. | 7 weeks |