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

Primary Purpose

Flexor Tendon Rupture

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
physiotherapy
activity-based therapy
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexor Tendon Rupture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

group 1

group 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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.

Full Information

First Posted
November 25, 2021
Last Updated
November 25, 2021
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05148585
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexor Tendon Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm 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.
Arm Title
group 2
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
activity-based therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Canadian occupational performance measure
Description
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.
Time Frame
six month
Title
Tampa Kinesiophobia Scale
Description
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.
Time Frame
six month
Secondary Outcome Measure Information:
Title
jebsen taylor hand function test
Description
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.
Time Frame
six month
Title
Michigan Hand Outcome Questionnaire:
Description
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.
Time Frame
six month
Title
grip strength
Description
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.
Time Frame
6 month
Title
range of motion
Description
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
Time Frame
six month
Title
Visual Analog Scale
Description
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.
Time Frame
7 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sumeyye CILDAN UYSAL
Phone
0258 296 4421
Ext
+90
Email
sumeyyeu@pau.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumeyye CILDAN UYSAL
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Pamukkale
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumeyye CILDAN UYSAL
Phone
0258 296 4421
Ext
+90
Email
sumeyyeu@pau.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
only measurements can be shared after the recruitment is finished.
IPD Sharing Time Frame
after the study has completed.
IPD Sharing Access Criteria
investigation
Citations:
PubMed Identifier
23898899
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.
Results Reference
background
PubMed Identifier
17996780
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.
Results Reference
background

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

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