Injury of Extensor Tendon of Hand (Disorder)NCT04221113
Functional Recovery Measurement : Comparing Early Active Mobilization Versus Immobilization After Extensor Tendon Repair in Zones IV to VIII
A study testing physiotherapy in people with Injury of Extensor Tendon of Hand (Disorder), run by Dow University of Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury of Extensor Tendon of Hand (Disorder)
- What is being tested?
- physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2019to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start10 Dec 2019
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury of Extensor Tendon of Hand (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaara Zahid, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221113
- Sponsor's protocol ID
- 1365
- Status last verified
- Jul 2020
- First submitted
- 16 Dec 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21889303
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principle Investigator
- ClinicalTrials.gov ID
- NCT04221113
- Acronym / sponsor ID
- 1365
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A ( Immobilization protocol) | Active comparator | Procedure: physiotherapyGroup 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 B( early active mobilization protocol). | Active comparator | Procedure: physiotherapyGroup 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either gender having simple lacerations of extrinsic extensor tendons · of the hand in · Verdan's zones IV-VIII
Key exclusion criteria (3 listed)
- Patients with complex injured hands like significant skin loss, bone and/or joint injuries. · Flexor tendon injuries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapyTwo 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. | Procedure or surgery | Group A ( Immobilization protocol), Group B( early active mobilization protocol). |
Primary outcome
To measure total active motion in the results of both groups to compare which one has better results.
Time frame: 8 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 21889303Sameem 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.
- 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 handLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy in people with Injury of Extensor Tendon of Hand (Disorder), run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure total active motion in the results of both groups to compare which one has better results. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.