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Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons Repair

U

University of Hail

Status

Enrolling

Conditions

Flexor Tendon Rupture

Treatments

Other: Early passive mobilization
Other: Controlled active motion

Study type

Interventional

Funder types

Other

Identifiers

NCT06420648
H-2024- 366

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

Early passive mobilization group
Experimental group
Description:
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 .
Treatment:
Other: Early passive mobilization
Controlled active motion group
Experimental group
Description:
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.
Treatment:
Other: Controlled active motion

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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