A Pilot Study on Exercise After Achilles Tendon Rupture

NCT01298024 | Completed Phase 2 DMC

• 1 other identifier: 2010/173
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus conventional treatment (late exercise) in patients with acute non-operative achilles tendon rupture (ATR).

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendon rupture; Non-surgical treatment; Exercise; Neuromuscular training

Outcome Measures

Primary Outcomes (1)

• Heel-raise

  Functional performance of calf muscles. The ability to perform a plantar flexion is assessed in a prone position at 1 and 4 weeks after the injury. At 8 and 16 weeks after the injury, the ability to perform a heel-raise standing on one leg is assessed.

  Week 16

Secondary Outcomes (13)

• Single limb standing balance

  At weeks 4, 8 and 16

• 30-meters walk test

  At weeks 8 and 16

• Single-limb mini squat

  At week 16

• VAS Pain

  At weeks 1, 4, 8 and 16

• Range of Motion

  At weeks 1, 4, 8 and 16

Study Arms (2)

Early neuromusclar exercise

EXPERIMENTAL

Other: Early Neuromuscular Exercise

Treatment as usual (late training)

ACTIVE COMPARATOR

Other: Early Neuromuscular Exercise

Interventions

Early Neuromuscular Exercise OTHER

30 patients are randomized to early neuromuscular exercise (n=15) or treatment as usual, i.e., late exercise (n=15). Both groups are given an orthosis and are instructed to wear this for eight weeks. The experimental group starts with a structured exercise program one week after the diagnosis. The patients attend one training session/week during eight weeks, guided by a physical therapist. The level of training is progressed during this time. The patients in the control group (treatment as usual) are given exercise instructions and information at one occasion; 2 weeks after diagnosis. Both groups are followed up, by a blinded assessor, with valid and reliable self-reported and physical function outcomes at 1, 4, 8 and 16 weeks after injury.

Also known as: Treatment as usual (late exercise)

Early neuromusclar exercise; Treatment as usual (late training)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women 18 - 60 years.
• The patient should before the achilles tendon rupture have been able to walk independently without aid, walk without limping, run/jog and be able to jump on one leg
• The patient shall be able to read, understand and to assimilate the written information about the study.

You may not qualify if:

• Previous achilles tendon rupture
• Acute achilles tendon rupture, more than 5 days.
• Medical restrictions regarding physical exercise, not related to the achilles tendon rupture

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Skåne University Hospital

Lund, Skåne County, 222 37, Sweden

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eva Ageberg, PT, PhD

  Lund University

  STUDY DIRECTOR

• Sylvia Resch, MD, PhD

  Skane University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 17, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

SE (1)