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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04221113
Other study ID # 1365
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2019
Est. completion date June 10, 2020

Study information

Verified date July 2020
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 10, 2020
Est. primary completion date June 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Injury of Extensor Tendon of Hand (Disorder)

Intervention

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.

Locations

Country Name City State
Pakistan Zaara Zahid Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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