- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290348
Effect of Dynamic Hand Splint on Hand ROM Post Extensor Tendon Repair
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt
- Mansoura international hospital, Dakahlia government, Egypt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dynamic hand splint
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).
|
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.
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.
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. |
|
Active Comparator: conventional medical treatment
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).
|
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
at baseline and after 1 months and 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of metacarpophalangeal joint range of motion
Time Frame: at baseline and after 1 months and 2 months
|
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.
|
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
|
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. |
at baseline and after 1 months and 2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Magdy-MSc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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