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Clinical Trials/NCT06420648
NCT06420648
Recruiting
N/A

A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II

University of Hail2 sites in 1 country50 target enrollmentJune 4, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Flexor Tendon Rupture
Sponsor
University of Hail
Enrollment
50
Locations
2
Primary Endpoint
Total active motion (TAM)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

a randomized controlled trial tends to compare 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand

Detailed Description

a randomized controlled trial tends to compare 2 rehabilitation approaches commonly used in the treatment of post-surgical flexor tendon repair of the hand. in this study, the authors try to fill the gap in the literature regarding the more effective approach. the comparisons between both approaches were scarce in previous literature. Participants will be randomly allocated to one of two treatment groups: early passive mobilization (EPM) using a modified Kleinert protocol or controlled active motion (CAM) using a modified Duran technique (n=20). Patients were assessed at baseline and then at the 6th and 12th weeks of interventions to quantify total active motion (TAM) of the proximal and distal interphalangeal joints using goniometry, and grip strength with dynamometry. the disability level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

Registry
clinicaltrials.gov
Start Date
June 4, 2024
End Date
December 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hisham Mohamed Hussein

principal investigator

University of Hail

Eligibility Criteria

Inclusion Criteria

  • males or females
  • between 25-50 years
  • Post-surgical repair of the flexor digitorum profundus (FDP) and superficialis (FDS) tendons of a single-digit
  • the case should be recent (2-3 days post-surgical)

Exclusion Criteria

  • age below 25 or above 50
  • a systemic disease affecting hand joints such as rheumatic arthritis
  • thumb flexor tendon repair will be excluded
  • chronic cases
  • concurrent injuries such as phalangeal fractures, joint injuries, or significant skin loss

Outcomes

Primary Outcomes

Total active motion (TAM)

Time Frame: after the 12th week of intervention

This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor" This formula determined the percentage of recovery of TAM. The results of TAM (%) were classified in four categories: "Excellent, good, fair, and poor"

handgrip strength

Time Frame: after the 12th week of intervention

Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows: % of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.

Functional disability

Time Frame: after the 12th week of intervention

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living

Study Sites (2)

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