Clinical trial NCT05148585: Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Tendon Injury
Official title: Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Flexor Tendon Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flexor Tendon Rupture
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Canadian occupational performance measure
timeFrame: six month
measure: Tampa Kinesiophobia Scale
timeFrame: six month
Secondary outcomes:
measure: jebsen taylor hand function test
timeFrame: six month
measure: Michigan Hand Outcome Questionnaire:
timeFrame: six month
measure: grip strength
timeFrame: 6 month
measure: range of motion
timeFrame: six month
measure: Visual Analog Scale
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
affiliation: Pamukkale University
name: Sumeyye CILDAN UYSAL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colaianni D, Provident I. The benefits of and challenges to the use of occupation in hand therapy. Occup Ther Health Care. 2010 Apr;24(2):130-46. doi: 10.3109/07380570903349378.
citation: Guzelkucuk U, Duman I, Taskaynatan MA, Dincer K. Comparison of therapeutic activities with therapeutic exercises in the rehabilitation of young adult patients with hand injuries. J Hand Surg Am. 2007 Nov;32(9):1429-35. doi: 10.1016/j.jhsa.2007.08.008.