Functional Recovery Measurement : Comparing Early Active Mobilization Versus Immobilization After Extensor Tendon Repair in Zones IV to VIII

Principle Investigator

Functional recovery measurement : Comparing early active mobilization versus immobilization after extensor tendon repair in zones IV to VIII.

Immobilization for six weeks has been the postoperative protocol for the patients with hand's extensor tendon repair in our institute. In this study early mobilization of the hand i.e. also an internationally followed way, is compared with the aforementioned immobilization protocol to see which turns out to be a better option in the interest of the patient.

Study Overview

• Status: Completed
• Conditions: Injury of Extensor Tendon of Hand (Disorder)
• Intervention / Treatment: Procedure: physiotherapy

Detailed Description

patients selection in both groups will be random by using close envolupe technique.

In group A ( immobilisation) physiotherapy will start by the end of 4th week and the upper limit of flexion would be 45 degrees.

In group B ( EAM) physiotherapy will start by the end of 1st week and the upper limit of flexion would be 30 degrees.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Zaara Zahid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of either gender having simple lacerations of extrinsic extensor tendons · of the hand in · Verdan's zones IV-VIII

  • Age range 18 to 65 years
  • Sharp Cut Injury

Exclusion Criteria:

• Patients with complex injured hands like significant skin loss, bone and/or joint injuries. · Flexor tendon injuries.

  • Partial tendon lacerations
  • Tendon injuries at multiple levels

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A ( Immobilization protocol); Group A patients will receive static splints.By the end of 4 weeks the splint will be modified and patients will start doing physiotherapy. Movement at MCPJ will be from 0 to 45 degrees.	Procedure: physiotherapy; Two protocols have been described for physiotherapy of post extensor tendon injuries. one is immobilization till 3 weeks and than gradual increase in active motion of hand. The second protocol is early active motion. this would be done under senior physiotherapist.
Active Comparator: Group B( early active mobilization protocol).; Group B patients will receive splints in such a way that from 3rd post operative day patients will be instructed to do physiotherapy. Initially MCPJ movement will be from 0 to 30 degrees.	Procedure: physiotherapy; Two protocols have been described for physiotherapy of post extensor tendon injuries. one is immobilization till 3 weeks and than gradual increase in active motion of hand. The second protocol is early active motion. this would be done under senior physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure total active motion in the results of both groups to compare which one has better results.	Flexion range and extension lag at each joint i.e MCPJ, PIPJ and DIPJ will be assessed at 2, 4 and 8 weeks of follow up. By using this following formula total active motion at each joint mentioned above will be assessed. TAM is calculated by the following formula: TAM =([MCPJ +PIPJ +DIPJ flexion]- [MCPJ +PIPJ +DIPJ extension lag	8 weeks

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Publications and helpful links

General Publications

• Sameem M, Wood T, Ignacy T, Thoma A, Strumas N. A systematic review of rehabilitation protocols after surgical repair of the extensor tendons in zones V-VIII of the hand. J Hand Ther. 2011 Oct-Dec;24(4):365-72; quiz 373. doi: 10.1016/j.jht.2011.06.005. Epub 2011 Sep 1.

Helpful Links

• To determine which rehabilitation protocol yields the best outcomes with respect to range of motion and grip strength in extensor zones V-VIII of the hand

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): June 10, 2020
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No