Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons Repair

Flexor Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420648
• Other study ID #: H-2024- 366
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: University of Hail
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Rupture

Intervention

Other:
• Early passive mobilization
a rehabilitation protocol for post-surgical repair of flexor tendons of the hand
• Controlled active motion
a rehabilitation protocol for post-surgical repair of flexor tendons of the hand

Locations

Country	Name	City	State
Saudi Arabia	Hail University Poly Clinic	Hail
Saudi Arabia	Hisham Hussein	Hail

Sponsors (1)

Lead Sponsor	Collaborator
University of Hail

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total active motion (TAM)	Active range of motion in proximal interphalangeal joint (PIP) and the distal interphalangeal joint (DIP) of the injured digits will be measured by manual hand goniometry. Outcome will be expressed by Strickland formula. TAM (%) = (Active flexion of PIP+DIP) - Extension Lag of both joints/175× 100 This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor"	at baseline
Primary	Total active motion (TAM)	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"	after the 12th week of intervention
Primary	handgrip strength	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.	baseline
Primary	handgrip strength	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.	after the 12th week of intervention
Primary	Functional disability	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	at baseline
Primary	Functional disability	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	after the 12th week of intervention