Effectiveness of Occupation-Based Exercise Program in Zone 2 Flexor Tendon Injuries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBerat Güngör
About this trial
Aim of the study is to evaluate the effects of a 4-week occupation-based exercise program given in addition to the conventional rehabilitation program on hand functions, range of motion, grip strength, pain and kinesiophobia in the post-operative rehabilitation of patients aged 18-65 years with zone 2 flexor tendon repair.
Expected results: To prove the effectiveness of occupation-based exercises in order to reduce the failure rates seen in the rehabilitation of zone 2 flexor tendon injuries, to increase patient compliance and motivation during the rehabilitation process, to improve functional outcomes by ensuring its inclusion in conventional treatment and to increase patient satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 18-65
Flexor zone 2 injury
At least 1 flexor digitorum superfisialis or flexor digitorum profundus tendon repair
No visual and hearing impairment
Disqualifiers
Concomitant flexor pollicis longus tendon injury
Concomitant extensor tendon injury
Accompanying fracture
Associated median/ulnar/radial nerve injury
Trial design
Design model
Parallel
Treatments tested in this trial
Occupation-Based Exercise Program
Other interventionIn the occupation-based exercise program, while trying to improve the range of motion and muscle strength of the hand, it is aimed to successfully return to daily life activities. For this reason daily activities are used instead of memorized range movements. In this way, the occupation-based exercise program provides a physical recovery in patients with hand injuries, while providing positive improvements in parameters related to the mind and spirit. Patients' participation, motivation and compliance with the treatment are increased in the hand rehabilitation process, which can be challenging for patients. In addition to the conventional treatment program, the study/experimental group, will be given occupation-based exercises for a total of 4 weeks between the 6th and 10th weeks postoperatively, 2 days a week with a physiotherapist and the other days with a home program.
Conventional therapy group
Other interventionConventional group treatment will be according the early passive hand rehabilitation program. Conventional group will be followed with a cast-splint made by the surgical team for the first 4 weeks within the scope of the conventional treatment program. From the 4th week onwards, the duration of splint use is gradually reduced and is completely discontinued from the 6th week onwards. At the end of the 4th week, depending on the wound condition, contrast bath, scar massage, retrograde massage, active and passive flexion, active extension and tendon shifting exercises are applied as tolerated. After the 6th week, isolated block exercises and stretching exercises are added if there is contracture. Strengthening exercises are started from the 8th-10th week.
Treatment groups
65 Participants
are divided into 2 treatment groupsGroup A: Occupation-based exercise groupExperimental treatment 1 intervention
Group B: Conventional therapy groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disabilities of The Arm, Shoulder and Hand Questionnaire (DASH)
In DASH Questionnaire a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).
Time frame
Participants will be evaluated at 6th, 10th and 16th weeks postoperative.Secondary outcomes
1
Modified Strickland Classification
Range of motion of the fingers will be measured with a goniometer and results will classified according to Modified Strickland Classification
Time frame
Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.2
Numerical Pain Rating Scale (NPRS)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.
Time frame
Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.3
Tampa Kinesiophobia Scale
The scale total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Time frame
Participants will be evaluated at 6th, 10th and 16th weeks postoperatively4
Grip strentgh
Hand grip strength will be measured with a hand dynamometer and finger grip strength with a pinchmeter.
Time frame
Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov
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