CClinicalTrials.gg
Status unknownNCT04912154Updated Jun 3, 2021

The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery

An interventional study of Rehabilitation protocol in Achilles Tendon Rupture, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-06-03.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Achilles Tendon Rupture

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Keywords

  • traditional rehabilitation protocol
  • accelerated rehabilitation protocol
  • ultrasonic monitoring
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In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 334 interventional studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Traditional rehabilitation protocol

    Traditional rehabilitation protocol after the surgery will be conducted

    Procedure: Rehabilitation protocol

  • Active comparator
    Accelerated rehabilitation protocol

    Accelerated rehabilitation protocol under ultrasonic monitoring after the surgery will be conducted

    Procedure: Rehabilitation protocol

Interventions

  • ProcedureRehabilitation protocol

    Rehabilitation protocol after open surgery for Achilles tendon rupture

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What researchers measure

Primary outcomes

  1. The time of return to light sports activity

    When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.

    Time frame: From operation to 1-year follow-up after the surgery

Secondary outcomes

  1. Range of motion (ROM) recovery time

    The recovery time will be recorded when the ROM is similar to that of the uninjured side.

    Time frame: from operation to 1-year follow-up after the surgery

  2. Recovery time of the single-legged heel rise height (SHRH)

    The 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.

    Time frame: From operation to 1-year follow-up after the surgery

Other outcomes

  1. visual analogue scale (VAS)

    VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.

    Time frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

  2. American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score

    The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.

    Time frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

  3. the Achilles tendon Total Rupture Score (ATRS)

    The ATRS includes 10 items; each item has a score ranging between 0 and 10 on a Likert scale, with 100 indicating no major limitations.

    Time frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

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Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04912154
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Jun 3, 2021
Start date
May 1, 2021
Primary completion
May 1, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Jun 3, 2021

Study contacts

Yang Lv, M.D.
Contact
lvyang42@126.com
+8682267010
Yuan Cao, M.M.
Contact
cy6415@126.com
+8682267010
Jie Qiao, M.D.
study chair · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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