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

P

Pamukkale University

Status

Unknown

Conditions

Flexor Tendon Rupture

Treatments

Other: physiotherapy
Other: activity-based therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05148585
60116787-020/1696

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

group 1
Active Comparator group
Description:
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.
Treatment:
Other: physiotherapy
group 2
Experimental group
Description:
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.
Treatment:
Other: activity-based therapy
Other: physiotherapy

Trial contacts and locations

1

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Central trial contact

Sumeyye CILDAN UYSAL

Data sourced from clinicaltrials.gov

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