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

NCT05148585 | Unknown DMC

• 1 other identifier: 60116787-020/1696
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexor Tendon Rupture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• jebsen taylor hand function test

  six month

• Michigan Hand Outcome Questionnaire:

  six month

• grip strength

  6 month

• range of motion

  six month

• Visual Analog Scale

  7 weeks

Study Arms (2)

group 1

ACTIVE COMPARATOR

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

group 2

EXPERIMENTAL

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; Other: activity-based therapy

Interventions

physiotherapy OTHER

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.

group 1; group 2

activity-based therapy OTHER

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.

group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those between the ages of 18-65
• flexor tendon injury
• Primary tendon repair performed
• a woman

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 23898899 BACKGROUND

• 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.

  PMID: 17996780 BACKGROUND

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Sumeyye CILDAN UYSAL

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumeyye CILDAN UYSAL

CONTACT

0258 296 4421; sumeyyeu@pau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: February 24, 2020
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the study has completed.
• Access Criteria: investigation

Locations

TU (1)