SplintsNCT07290348
Effect of Dynamic Hand Splint on Hand ROM Post Extensor Tendon Repair
A study testing customized dynamic hand splint, traditional treatment (first stage) and traditional treatment (second and third stage) in people with Splints and Range of Motion, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study was to evaluate the effectiveness of dynamic hand splint on hand range of motion following extensor tendon repair. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Splints, Range of Motion, Extensor Tendons of Finger Anomalies
- What is being tested?
- customized dynamic hand splint, traditional treatment (first stage) and traditional treatment (second and third stage)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Jan 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients are both males and females.
- Their age will be in the range of 20-40 years.
- All patients suffering from extensor tendon injuries in zone 5 or 6.
- All patients undergo extensor tendon repair surgery.
- All patients will begin the treatment program from the third week post-operative.
- All patients enrolled in the study will have their informed consent.
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Patients with associated diseases (diabetes mellitus, infectious diseases, autoimmune disease) that will interfere with the healing process.
- Patients taking medication that alters the healing process (e.g., corticosteroids, chemotherapy, or radiation).
- Pregnancy or epilepsy.
- Elderly patients.
- Skin disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura international hospital, Dakahlia government, Egypt
Al Mansurah
About this study
The purpose of the study was to evaluate the effectiveness of dynamic hand splint on hand range of motion following extensor tendon repair.
Read the detailed description
The extensor muscles to the digits are weaker; their capacity for work and their amplitude of glide are less than those of their flexor antagonists, yet they require a latitude of motion that is not necessary for flexor function. Extensor tendons are thinner and broader than flexor tendons. They are superficial in comparison with the flexor tendons, allowing adhesion to the fascial layers and skin. They have a broad tendon-to-bone interface that can result in dense adhesions. Shortening of the extensor tendon because of surgery may result in difficulty regaining full flexion. Dorsal swelling may prevent the tendons from gliding. Recreating the normal balance between intrinsic and extrinsic muscle/tendon units can be a challenging task for surgeons and therapists following extensor tendon injury. Common functional complications include loss of flexion, extensor lag, and decreased grip strength. To prevent these complications, extensor tendon approaches, similar to flexor tendon approaches, have evolved to include controlled passive and active mobilization using a dynamic splint immediately following surgery
- Being tested
- customized dynamic hand splint, traditional treatment (first stage), traditional treatment (second and third stage)
- Medical subject headings
- Hapnes Boman Skeie syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized dynamic hand splintOther
After 3 weeks of repair surgery, both groups were asked to take of the static splints, then the patients in group A (study group) were asked to wear customized dynamic hand splint daytime between sessions whole duration from third week post operative for 2 months till the end of the rehabilitation sessions, on the other hand the patients in group B (control group) were not asked to wear customized dynamic hand splint.
traditional treatment (first stage)Other
All patients underwent a standardized rehabilitation program involving chair exercises. Key components included management of postoperative hand edema through distal-to-proximal massage to enhance tendon glide and range of motion; deep friction massage to reduce adhesions of postoperative scars; positive effects of massage therapy on hypertrophic and burn scar thickness; use of ultrasound on repaired tendons to minimize adhesions and promote healing; and gentle passive range of motion exercises for wrist and finger joints to gradually restore motion.
traditional treatment (second and third stage)Other
This stage spanned two weeks following rehabilitation, during which all patients in both groups performed gentle stretching, active-assisted, and active free range of motion exercises to improve neuromuscular control and joint movements.
This stage lasted one month, during which all patients engaged in active resisted range of motion, strengthening exercises, and functional training to restore muscle power and daily activity levels. Thera-band resistance training can improve muscle strength and functional fitness in older adults in community settings, serving as a safe and manageable physical activity that nursing staff can seamlessly integrate into daily routines.
| Study group | Role | What they receive |
|---|---|---|
| dynamic hand splint | Experimental | This group included 20 patients suffering from cuts of the extensor tendon of their hand in zone 5 or 6 and underwent tendon repair surgery in this study. They wear a dynamic hand splint after 3 weeks post-operative for 2 months in addition to their conventional medical treatment and traditional care (dressing). Receives: Other: customized dynamic hand splint; Other: traditional treatment (first stage); Other: traditional treatment (second and third stage) |
| conventional medical treatment | Active comparator | This group included 20 patients suffering from cuts of the extensor tendon of their hand in zone 5 or 6 and underwent tendon repair surgery in this study. They, without wearing a dynamic hand splint, received their conventional medical treatment and traditional care (dressing). Receives: Other: traditional treatment (first stage); Other: traditional treatment (second and third stage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of wrist range of motion
The study measured the range of motion of the wrist at three stages: prior to treatment, after one month, and at the end of the treatment. Patients were positioned sitting with their elbows on a table.
An electronic goniometer was employed for the measurements, ensuring the wrist was neutral (0°) for extension assessments. For wrist extension, the forearm was pronated and the elbow fully extended, with the goniometer aligned with the lateral side of the ulna and the fifth metacarpal for accurate measurement
Measured: at baseline and after 1 months and 2 months
Secondary outcomes (2)
assessment of metacarpophalangeal joint range of motion
The study measured the range of motion of the metacarpophalangeal joint of the fingers at three stages: prior to treatment, after one month, and at the end of the treatment.To measure the metacarpophalangeal joint, patients positioned their hands outside the table, while an electronic goniometer was aligned on the dorsal side of the metacarpal and proximal phalanx for accurate measurement.
Measured: at baseline and after 1 months and 2 months
assessment of interphalangeal joints' range of motion
The study measured the range of motion of the proximal and distal interphalangeal joints of the fingers at three stages: prior to treatment, after one month, and at the end of the treatment.
The measurement of proximal interphalangeal joints involved patients positioning their hands outside a table while an electronic goniometer was aligned on the dorsal side of the proximal and middle phalanx of the targeted finger. For Distal interphalangeal joints, the setup differed slightly, with alignment on the lateral side of the middle phalanx and distal phalanx of the targeted finger.
Measured: at baseline and after 1 months and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Aug 2023
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SplintsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Helmi Mohamed Elmahdy Badra, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290348
- Sponsor's protocol ID
- Magdy-MSc
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dynamic Hand Splint on Hand ROM Post Extensor Tendon Repair
- ClinicalTrials.gov ID
- NCT07290348
- Acronym / sponsor ID
- Magdy-MSc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 18 Dec 2025 (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 purpose of the study was to evaluate the effectiveness of dynamic hand splint on hand range of motion following extensor tendon repair.
Detailed description
The extensor muscles to the digits are weaker; their capacity for work and their amplitude of glide are less than those of their flexor antagonists, yet they require a latitude of motion that is not necessary for flexor function. Extensor tendons are thinner and broader than flexor tendons. They are superficial in comparison with the flexor tendons, allowing adhesion to the fascial layers and skin. They have a broad tendon-to-bone interface that can result in dense adhesions. Shortening of the extensor tendon because of surgery may result in difficulty regaining full flexion. Dorsal swelling may prevent the tendons from gliding. Recreating the normal balance between intrinsic and extrinsic muscle/tendon units can be a challenging task for surgeons and therapists following extensor tendon injury. Common functional complications include loss of flexion, extensor lag, and decreased grip strength. To prevent these complications, extensor tendon approaches, similar to flexor tendon approaches, have evolved to include controlled passive and active mobilization using a dynamic splint immediately following surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dynamic hand splint | Experimental | Other: customized dynamic hand splint, Other: traditional treatment (first stage), Other: traditional treatment (second and third stage)This group included 20 patients suffering from cuts of the extensor tendon of their hand in zone 5 or 6 and underwent tendon repair surgery in this study. They wear a dynamic hand splint after 3 weeks post-operative for 2 months in addition to their conventional medical treatment and traditional care (dressing). |
| conventional medical treatment | Active comparator | Other: traditional treatment (first stage), Other: traditional treatment (second and third stage)This group included 20 patients suffering from cuts of the extensor tendon of their hand in zone 5 or 6 and underwent tendon repair surgery in this study. They, without wearing a dynamic hand splint, received their conventional medical treatment and traditional care (dressing). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients are both males and females.
- Their age will be in the range of 20-40 years.
- All patients suffering from extensor tendon injuries in zone 5 or 6.
- All patients undergo extensor tendon repair surgery.
- All patients will begin the treatment program from the third week post-operative.
Key exclusion criteria (6 listed)
- The potential participants will be excluded if they meet one of the following criteria:
- Patients with associated diseases (diabetes mellitus, infectious diseases, autoimmune disease) that will interfere with the healing process.
- Patients taking medication that alters the healing process (e.g., corticosteroids, chemotherapy, or radiation).
- Pregnancy or epilepsy.
- Elderly patients.
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 |
|---|---|---|
| customized dynamic hand splintAfter 3 weeks of repair surgery, both groups were asked to take of the static splints, then the patients in group A (study group) were asked to wear customized dynamic hand splint daytime between sessions whole duration from third week post operative for 2 months till the end of the rehabilitation sessions, on the other hand the patients in group B (control group) were not asked to wear customized dynamic hand splint. | Other | dynamic hand splint |
| traditional treatment (first stage)All patients underwent a standardized rehabilitation program involving chair exercises. Key components included management of postoperative hand edema through distal-to-proximal massage to enhance tendon glide and range of motion; deep friction massage to reduce adhesions of postoperative scars; positive effects of massage therapy on hypertrophic and burn scar thickness; use of ultrasound on repaired tendons to minimize adhesions and promote healing; and gentle passive range of motion exercises for wrist and finger joints to gradually restore motion. | Other | conventional medical treatment, dynamic hand splint |
| traditional treatment (second and third stage)This stage spanned two weeks following rehabilitation, during which all patients in both groups performed gentle stretching, active-assisted, and active free range of motion exercises to improve neuromuscular control and joint movements. This stage lasted one month, during which all patients engaged in active resisted range of motion, strengthening exercises, and functional training to restore muscle power and daily activity levels. Thera-band resistance training can improve muscle strength and functional fitness in older adults in community settings, serving as a safe and manageable physical activity that nursing staff can seamlessly integrate into daily routines. | Other | conventional medical treatment, dynamic hand splint |
Primary outcome
assessment of wrist range of motion
Time frame: at baseline and after 1 months and 2 months
The study measured the range of motion of the wrist at three stages: prior to treatment, after one month, and at the end of the treatment. Patients were positioned sitting with their elbows on a table. An electronic goniometer was employed for the measurements, ensuring the wrist was neutral (0°) for extension assessments. For wrist extension, the forearm was pronated and the elbow fully extended, with the goniometer aligned with the lateral side of the ulna and the fifth metacarpal for accurate measurement
2 secondary outcomes
assessment of metacarpophalangeal joint range of motion
Time frame: at baseline and after 1 months and 2 months
assessment of interphalangeal joints' range of motion
Time frame: at baseline and after 1 months and 2 months
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 18 Dec 2025.
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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 customized dynamic hand splint, traditional treatment (first stage) and traditional treatment (second and third stage) in people with Splints and Range of Motion, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 6 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 18 Dec 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 Egypt. 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?
assessment of wrist range of motion (time frame: at baseline and after 1 months and 2 months). 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 18 Dec 2025.