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

NCT04221113 | Completed DMC

• 1 other identifier: 1365
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Injury of Extensor Tendon of Hand (Disorder)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A ( Immobilization protocol)

ACTIVE COMPARATOR

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

Group B( early active mobilization protocol).

ACTIVE COMPARATOR

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

Interventions

physiotherapy 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 A ( Immobilization protocol); Group B( early active mobilization protocol).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Zaara Zahid

Karachi, Sindh, 74200, Pakistan

Location

Related 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.

  PMID: 21889303 BACKGROUND

Related 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

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study will be single blinded means that patient will be unaware of protocol written inside the envolupe.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: January 9, 2020
• Study Start: December 10, 2019
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)