Flexor Tendon RuptureNCT05148585
Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Tendon Injury
A study testing physiotherapy and activity-based therapy in people with Flexor Tendon Rupture, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Flexor Tendon Rupture
- What is being tested?
- physiotherapy and activity-based therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those between the ages of 18-65
- flexor tendon injury
- Primary tendon repair performed
- a woman
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli, Pamukkale
Sumeyye CILDAN UYSAL, 0258 296 4421 ext. +90, sumeyyeu@pau.edu.tr
About this study
Official title: Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Flexor Tendon Injury
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.
Read the 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.
- Conditions
- Flexor Tendon Rupture
- Being tested
- physiotherapy, activity-based therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
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.
activity-based therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: physiotherapy; Other: activity-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: six month
Secondary outcomes (5)
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.
Measured: six month
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.
Measured: six month
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.
Measured: 6 month
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
Measured: six month
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start24 Feb 2020
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Flexor Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyye Cildan Uysal, Pamukkale University
- Investigators
- Sumeyye CILDAN UYSAL, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148585
- Sponsor's protocol ID
- 60116787-020/1696
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only measurements can be shared after the recruitment is finished.
Publications
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.
PubMed 23898899Guzelkucuk 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.
PubMed 17996780
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Flexor Tendon Injury
- ClinicalTrials.gov ID
- NCT05148585
- Acronym / sponsor ID
- 60116787-020/1696
- Conditions
- Flexor Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Other: physiotherapygroup 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 | Experimental | Other: physiotherapy, Other: activity-based therapygroup 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those between the ages of 18-65
- flexor tendon injury
- Primary tendon repair performed
- a woman
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapyPatients 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. | Other | group 1, group 2 |
| activity-based therapypatients 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. | Other | group 2 |
Primary outcome
The Canadian occupational performance measure
Time frame: six month
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
Time frame: six month
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.
5 secondary outcomes
jebsen taylor hand function test
Time frame: six month
Michigan Hand Outcome Questionnaire:
Time frame: six month
grip strength
Time frame: 6 month
range of motion
Time frame: six month
Visual Analog Scale
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Background: PubMed 23898899Colaianni 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.
- Background: PubMed 17996780Guzelkucuk 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.
- Individual participant dataSharing planned: Yes. only measurements can be shared after the recruitment is finished.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumeyye CILDAN UYSAL principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy and activity-based therapy in people with Flexor Tendon Rupture, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sumeyye CILDAN UYSAL (0258 296 4421 ext. +90, sumeyyeu@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Canadian occupational performance measure (time frame: six month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148585, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.