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

NCT ID: NCT04221113

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-06-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Injury of Extensor Tendon of Hand (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Healthy patients with only extensor tendon injuries will be recruited in this study and will randomly divided in two groups. An intervention in the form of rehabilitation will be given to patients in two different protocols than outcomes will be assessed.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
This study will be single blinded means that patient will be unaware of protocol written inside the envolupe.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

physiotherapy

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

physiotherapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zaara Zahid

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zaara Zahid

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 21889303 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/21889303

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

Other Identifiers

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1365

Identifier Type: -

Identifier Source: org_study_id

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