Effect of Dynamic Hand Splint on Hand ROM Post Extensor Tendon Repair

NCT ID: NCT07290348

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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

Conditions

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Splints Range of Motion Extensor Tendons of Finger Anomalies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type EXPERIMENTAL

customized dynamic hand splint

Intervention Type OTHER

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)

Intervention Type 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)

Intervention Type 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.

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).

Group Type ACTIVE_COMPARATOR

traditional treatment (first stage)

Intervention Type 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)

Intervention Type 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.

Interventions

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customized dynamic hand splint

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Magdy Helmi Mohamed Elmahdy Badra

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura international hospital, Dakahlia government, Egypt

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Magdy-MSc

Identifier Type: -

Identifier Source: org_study_id