Flexor Tendon RuptureNCT06420648
Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons Repair
A study testing Early passive mobilization in people with Flexor Tendon Rupture, run by University of Hail at 2 sites in Saudi Arabia.
Trial summary
a randomized controlled trial tends to compare 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Flexor Tendon Rupture
- What is being tested?
- Early passive mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 4 Jun 2024to 30 Dec 2024
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- males or females
- between 25-50 years
- Post-surgical repair of the flexor digitorum profundus (FDP) and superficialis (FDS) tendons of a single-digit
- the case should be recent (2-3 days post-surgical)
Who cannot join
- age below 25 or above 50
- a systemic disease affecting hand joints such as rheumatic arthritis
- thumb flexor tendon repair will be excluded
- chronic cases
- concurrent injuries such as phalangeal fractures, joint injuries, or significant skin loss
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Hail University Poly Clinic
Ha'il, 2442
Hisham Hussein, 0543704108, hm.hussein@uoh.edu.sa
- Recruiting
Hisham Hussein
Ha'il, 3994
Hisham Hussein, 0543704108, hm.hussein@uoh.edu.sa
About this study
Official title: A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II
a randomized controlled trial tends to compare 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand
Read the detailed description
a randomized controlled trial tends to compare 2 rehabilitation approaches commonly used in the treatment of post-surgical flexor tendon repair of the hand. in this study, the authors try to fill the gap in the literature regarding the more effective approach. the comparisons between both approaches were scarce in previous literature.
Participants will be randomly allocated to one of two treatment groups: early passive mobilization (EPM) using a modified Kleinert protocol or controlled active motion (CAM) using a modified Duran technique (n=20). Patients were assessed at baseline and then at the 6th and 12th weeks of interventions to quantify total active motion (TAM) of the proximal and distal interphalangeal joints using goniometry, and grip strength with dynamometry. the disability level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
- Conditions
- Flexor Tendon Rupture
- Being tested
- Early passive mobilization, Controlled active motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early passive mobilizationOther
Also called modified Kleinert protocol
a rehabilitation protocol for post-surgical repair of flexor tendons of the hand
Controlled active motionOther
a rehabilitation protocol for post-surgical repair of flexor tendons of the hand
| Study group | Role | What they receive |
|---|---|---|
| Early passive mobilization group | Experimental | The modified Kleinert protocol will be used as an EPM procedure. Within 3 to 5 days following surgery, the affected hand will be placed inside the dorsal slab Kleinert splint with the wrist in 30-40 flexion; metacarpophalangeal joint (MP) in 60-70-degree flexion; PIP and DIP joints in extension. Rubber band traction will be directed to the fingernail from the wrist, with a palmar pulley system. All patients will perform passive flexion and active extension exercises with an active hold for 2-3 seconds 10 times per hour. Traction will be removed at the end of 3rd week and very gentle active flexion will start at the 4th week. The splint will be removed in the 5th-6th weeks. Blocking exercises will be started at 7th-8th weeks and resisted exercises will be started after the 8th week with the full function permitted by week 12th week . Receives: Other: Early passive mobilization |
| Controlled active motion group | Experimental | A modified CAM protocol will be used. Exercises will be performed hourly for 10 repetitions in the form of passive flexion and active extension exercises with an active hold of the fingers in the flexed position for 2-3 seconds. Receives: Other: Controlled active motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total active motion (TAM)
Active range of motion in proximal interphalangeal joint (PIP) and the distal interphalangeal joint (DIP) of the injured digits will be measured by manual hand goniometry. Outcome will be expressed by Strickland formula. TAM (%) = (Active flexion of PIP+DIP) - Extension Lag of both joints/175× 100 This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor"
Measured: at baseline
Total active motion (TAM)
This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor" This formula determined the percentage of recovery of TAM. The results of TAM (%) were classified in four categories: "Excellent, good, fair, and poor"
Measured: after the 12th week of intervention
handgrip strength
Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows:
% of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.
Measured: baseline
handgrip strength
Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows:
% of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.
Measured: after the 12th week of intervention
Functional disability
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living
Measured: at baseline
Functional disability
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living
Measured: after the 12th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start4 Jun 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon RuptureStudies 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
- Parallel groups
- Model description
- 2 arm randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohamed Hussein, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420648
- Sponsor's protocol ID
- H-2024- 366
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available with the senior author upon request
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II
- ClinicalTrials.gov ID
- NCT06420648
- Acronym / sponsor ID
- H-2024- 366
- Conditions
- Flexor Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 May 2024 (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.
a randomized controlled trial tends to compare 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand
Detailed description
a randomized controlled trial tends to compare 2 rehabilitation approaches commonly used in the treatment of post-surgical flexor tendon repair of the hand. in this study, the authors try to fill the gap in the literature regarding the more effective approach. the comparisons between both approaches were scarce in previous literature.
Participants will be randomly allocated to one of two treatment groups: early passive mobilization (EPM) using a modified Kleinert protocol or controlled active motion (CAM) using a modified Duran technique (n=20). Patients were assessed at baseline and then at the 6th and 12th weeks of interventions to quantify total active motion (TAM) of the proximal and distal interphalangeal joints using goniometry, and grip strength with dynamometry. the disability level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Early passive mobilization group | Experimental | Other: Early passive mobilizationThe modified Kleinert protocol will be used as an EPM procedure. Within 3 to 5 days following surgery, the affected hand will be placed inside the dorsal slab Kleinert splint with the wrist in 30-40 flexion; metacarpophalangeal joint (MP) in 60-70-degree flexion; PIP and DIP joints in extension. Rubber band traction will be directed to the fingernail from the wrist, with a palmar pulley system. All patients will perform passive flexion and active extension exercises with an active hold for 2-3 seconds 10 times per hour. Traction will be removed at the end of 3rd week and very gentle active flexion will start at the 4th week. The splint will be removed in the 5th-6th weeks. Blocking exercises will be started at 7th-8th weeks and resisted exercises will be started after the 8th week with the full function permitted by week 12th week . |
| Controlled active motion group | Experimental | Other: Controlled active motionA modified CAM protocol will be used. Exercises will be performed hourly for 10 repetitions in the form of passive flexion and active extension exercises with an active hold of the fingers in the flexed position for 2-3 seconds. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- males or females
- between 25-50 years
- Post-surgical repair of the flexor digitorum profundus (FDP) and superficialis (FDS) tendons of a single-digit
- the case should be recent (2-3 days post-surgical)
Key exclusion criteria (5 listed)
- age below 25 or above 50
- a systemic disease affecting hand joints such as rheumatic arthritis
- thumb flexor tendon repair will be excluded
- chronic cases
- concurrent injuries such as phalangeal fractures, joint injuries, or significant skin loss
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 |
|---|---|---|
| Early passive mobilizationAlso: modified Kleinert protocola rehabilitation protocol for post-surgical repair of flexor tendons of the hand | Other | Early passive mobilization group |
| Controlled active motiona rehabilitation protocol for post-surgical repair of flexor tendons of the hand | Other | Controlled active motion group |
Primary outcome
Total active motion (TAM)
Time frame: at baseline
Active range of motion in proximal interphalangeal joint (PIP) and the distal interphalangeal joint (DIP) of the injured digits will be measured by manual hand goniometry. Outcome will be expressed by Strickland formula. TAM (%) = (Active flexion of PIP+DIP) - Extension Lag of both joints/175× 100 This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor"
Total active motion (TAM)
Time frame: after the 12th week of intervention
This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor" This formula determined the percentage of recovery of TAM. The results of TAM (%) were classified in four categories: "Excellent, good, fair, and poor"
handgrip strength
Time frame: baseline
Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows: % of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.
handgrip strength
Time frame: after the 12th week of intervention
Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows: % of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.
Functional disability
Time frame: at baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living
Functional disability
Time frame: after the 12th week of intervention
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No. data will be available with the senior author upon request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early passive mobilization in people with Flexor Tendon Rupture, run by University of Hail at 2 sites in Saudi Arabia.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total active motion (TAM) (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2024.