Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons Repair

NCT06420648 | Recruiting

• 1 other identifier: H-2024- 366
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Flexor Tendon Rupture

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Early passive mobilization group

EXPERIMENTAL

The modified Kleinert protocol will be used as an EPM procedure. Within 3 to 5 days following surgery, the affected hand will be placed inside the dorsal slab Kleinert splint with the wrist in 30-40 flexion; metacarpophalangeal joint (MP) in 60-70-degree flexion; PIP and DIP joints in extension. Rubber band traction will be directed to the fingernail from the wrist, with a palmar pulley system. All patients will perform passive flexion and active extension exercises with an active hold for 2-3 seconds 10 times per hour. Traction will be removed at the end of 3rd week and very gentle active flexion will start at the 4th week. The splint will be removed in the 5th-6th weeks. Blocking exercises will be started at 7th-8th weeks and resisted exercises will be started after the 8th week with the full function permitted by week 12th week .

Other: Early passive mobilization

Controlled active motion group

EXPERIMENTAL

A modified CAM protocol will be used. Exercises will be performed hourly for 10 repetitions in the form of passive flexion and active extension exercises with an active hold of the fingers in the flexed position for 2-3 seconds.

Other: Controlled active motion

Interventions

Early passive mobilization OTHER

a rehabilitation protocol for post-surgical repair of flexor tendons of the hand

Also known as: modified Kleinert protocol

Early passive mobilization group

Controlled active motion OTHER

a rehabilitation protocol for post-surgical repair of flexor tendons of the hand

Controlled active motion group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hail: lead

Study Sites (2)

Hail University Poly Clinic

Hail, 2442, Saudi Arabia

RECRUITING

Hisham Hussein

Hail, 3994, Saudi Arabia

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 2 arm randomized controlled trial

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: June 4, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)