NCT07290348

Brief Summary

The purpose of the study was to evaluate the effectiveness of dynamic hand splint on hand range of motion following extensor tendon repair.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

December 5, 2025

Last Update Submit

December 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    at baseline and after 1 months and 2 months

Secondary Outcomes (2)

  • assessment of metacarpophalangeal joint range of motion

    at baseline and after 1 months and 2 months

  • assessment of interphalangeal joints' range of motion

    at baseline and after 1 months and 2 months

Study Arms (2)

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).

Other: customized dynamic hand splintOther: 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).

Other: traditional treatment (first stage)Other: traditional treatment (second and third stage)

Interventions

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.

conventional medical treatmentdynamic hand splint

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 treatmentdynamic 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.

dynamic hand splint

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura international hospital, Dakahlia government, Egypt

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Hapnes Boman Skeie syndrome

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

August 1, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations