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The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery

A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Accelerated Rehabilitation Protocol Under Ultrasonic Monitoring for Achilles Tendon Rupture

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04912154
Enrollment
200
Registered
2021-06-03
Start date
2021-05-01
Completion date
2023-06-01
Last updated
2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Rupture

Keywords

traditional rehabilitation protocol, accelerated rehabilitation protocol, ultrasonic monitoring

Brief summary

This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , respectively, to study the difference in efficacy between the groups.

Detailed description

This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. The inclusion criteria are patients with an acute closed single-legged complete Achilles tendon rupture, and an age of 18 to 60 years. The exclusion criteria are patients with prior Achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). Other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. All patients will be treated surgically with the same suture technique.

Interventions

Rehabilitation protocol after open surgery for Achilles tendon rupture

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* acute closed single-legged complete Achilles tendon rupture . * age of 18 to 60 years.

Exclusion criteria

* patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). * an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm) . * those without rehabilitation or follow-up outcomes.

Design outcomes

Primary

MeasureTime frameDescription
The time of return to light sports activityFrom operation to 1-year follow-up after the surgeryWhen the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.

Secondary

MeasureTime frameDescription
Range of motion (ROM) recovery timefrom operation to 1-year follow-up after the surgeryThe recovery time will be recorded when the ROM is similar to that of the uninjured side.
Recovery time of the single-legged heel rise height (SHRH)From operation to 1-year follow-up after the surgeryThe heel rise height is measured as the distance from the ground to the heel when the patient lift the heel while keeping the knee straight. The recovery time is noted when the SHRH is similar to that of the opposite leg.

Other

MeasureTime frameDescription
visual analogue scale (VAS)2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgeryVAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgeryThe AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.
the Achilles tendon Total Rupture Score (ATRS)2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgeryThe ATRS includes 10 items; each item has a score ranging between 0 and 10 on a Likert scale, with 100 indicating no major limitations.

Countries

China

Contacts

Primary ContactYang Lv, M.D.
lvyang42@126.com+8682267010
Backup ContactYuan Cao, M.M.
cy6415@126.com+8682267010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026