Forearm FractureNCT06562218
The Effectiveness of Cross-training on an Immobilised Forearm
A study testing isokinetic strengthening exercise and conventional exercise programm in people with Forearm Fracture, run by Dilara Ekici Zincirci at 1 site in Turkey (Türkiye).
Trial summary
The cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Forearm Fracture
- What is being tested?
- isokinetic strengthening exercise and conventional exercise programm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Aug 2024to 30 Mar 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic unilateral forearm fracture (treated surgically or conservatively and immobilised in a cast)
Who cannot join
- Previous upper limb surgery/joint disease - deformity affecting hand-wrist function
- Any neurological condition affecting the upper extremity (stroke, Parkinson's disease; multiple sclerosis, reflex sympathetic dystrophy, peripheral nerve injury)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul, Istanbul
About this study
Official title: The Effectiveness of Cross-training on an Immobilised Forearm Due to Fracture
The cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. The aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.
- Conditions
- Forearm Fracture
- Being tested
- isokinetic strengthening exercise, conventional exercise programm
- Keywords
- fracture, immobilisation, cross-education, muscle strength
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic strengthening exerciseProcedure or surgery
Participants' isokinetic strength measurements will be assessed using the Cybex II Humac Norm isokinetic dynamometer. A strengthening programme will be performed for a total of 12 sessions, 3 days a week for 4 weeks, at 20 degrees of flexion, 20 degrees of extension, 60-90 and 180 degrees/s speed.
At the beginning and end of the 12th session, isokinetic and isometric muscle performance tests will be performed on the healthy wrist, and isometric wrist flexor and extensor strength measurements will be performed in neutral position 1 week after removal of the cast on the fractured wrist.
conventional exercise programmProcedure or surgery
The immobilised limb was given finger grip exercises.
| Study group | Role | What they receive |
|---|---|---|
| cross training group | Experimental | Group whose healthy arm (unbroken side) is strengthened Receives: Procedure: isokinetic strengthening exercise |
| control group | Experimental | group given conventional exercise to the fractured arm Receives: Procedure: conventional exercise programm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist isometric flexion muscle strength
The isometric flexion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.
Measured: 1 year
Wrist isometric extansion muscle strength
The isometric extansion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start26 Aug 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm FractureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilara Ekici Zincirci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilara Ekici Zincirci, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562218
- Sponsor's protocol ID
- CTO-CE1
- Status last verified
- Nov 2024
- First submitted
- 16 Aug 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cross-training on an Immobilised Forearm Due to Fracture
- ClinicalTrials.gov ID
- NCT06562218
- Acronym / sponsor ID
- CTO-CE1
- Conditions
- Forearm Fracture
- Keywords
- fracture, immobilisation, cross-education, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dilara Ekici ZincirciUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 20 Aug 2024 (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 cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. The aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| cross training group | Experimental | Procedure: isokinetic strengthening exerciseGroup whose healthy arm (unbroken side) is strengthened |
| control group | Experimental | Procedure: conventional exercise programmgroup given conventional exercise to the fractured arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Traumatic unilateral forearm fracture (treated surgically or conservatively and immobilised in a cast)
Key exclusion criteria (2 listed)
- Previous upper limb surgery/joint disease - deformity affecting hand-wrist function
- Any neurological condition affecting the upper extremity (stroke, Parkinson's disease; multiple sclerosis, reflex sympathetic dystrophy, peripheral nerve injury)
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 |
|---|---|---|
| isokinetic strengthening exerciseParticipants' isokinetic strength measurements will be assessed using the Cybex II Humac Norm isokinetic dynamometer. A strengthening programme will be performed for a total of 12 sessions, 3 days a week for 4 weeks, at 20 degrees of flexion, 20 degrees of extension, 60-90 and 180 degrees/s speed. At the beginning and end of the 12th session, isokinetic and isometric muscle performance tests will be performed on the healthy wrist, and isometric wrist flexor and extensor strength measurements will be performed in neutral position 1 week after removal of the cast on the fractured wrist. | Procedure or surgery | cross training group |
| conventional exercise programmThe immobilised limb was given finger grip exercises. | Procedure or surgery | control group |
Primary outcome
Wrist isometric flexion muscle strength
Time frame: 1 year
The isometric flexion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.
Wrist isometric extansion muscle strength
Time frame: 1 year
The isometric extansion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic strengthening exercise and conventional exercise programm in people with Forearm Fracture, run by Dilara Ekici Zincirci 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist isometric flexion muscle strength (time frame: 1 year). 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?
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 26 Jun 2025.