Effect of Additional Treatment With NMES After Achilles Tendon Rupture

NCT06009978 | Recruiting

• 1 other identifier: 2022-00921-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Increased knowledge is needed about new methods how to treat patients with Achilles tendon ruptures (ATR). A goal is to be able to individualize as well as improve treatment beyond the question about if surgery should be used or not. An overall aim of the project is to, in a randomized controlled trial (RCT), explore what impact a new treatment method with Neuromuscular Electrical Stimulation (NMES) - attached on the patients ́ calf muscles on the injured leg - in the early stages after an ATR, may have on tendon length, functional performance, biomechanical variables and patient reported outcome, both in the short and long term after the injury. 70 patients are planned to be included in this RCT and will be evaluated 3,6 and 12 months after their injury. Primary outcome will be heel-rise height. Secondary outcome will be tendon length, jumping ability, patient- reported outcome and biomechanical loading pattern. There is also a need to explore if the patients ́ loading patterns improve after treatment with NMES. Therefore, biomechanical variables in lower leg during walking and jumping will also be evaluated one year after their injury. The planned studies include completely new ways of exploring how to optimize the rehabilitation after an ATR. Since there might be an increased risk for overuse injuries in the healthy limb, there will also be focus on how the non- injured limb may be affected of an ATR. Taken together, this new knowledge can be helpful in the clinical setting to individualize and optimize patients' treatment and rehabilitation with the goal to guide the patient return to the same, or higher level of, physical activity as before the injury.

Conditions

Achilles Tendon Rupture; Physical Disability

Keywords

Achilles Tendon Rupture; Rehabilitation; Neuromuscular Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• Heel-rise height during heel-rise work test

  Evaluation of heel-rise height during heel-rise work test. Comparison between groups in heel-rise height Limb Symmetry Index (LSI) - injured side/healthy side \*100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome

  12 months

• Heel-rise height during heel-rise work test

  Evaluation of heel-rise height during heel-rise work test. Comparison between groups in heel-rise height (LSI)- injured side/healthy side \*100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome

  6 months

• Heel-rise height during heel-rise work test

  Evaluation of heel-rise height during heel-rise work test using. Comparison between groups in heel-rise height (LSI)- injured side/healthy side \*100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome

  3 months

Secondary Outcomes (24)

• Tendon length

  12 months

• Tendon length

  6 months

• Tendon length

  3 months

• Gastrocnemius Cross-sectional area

  12 months

• Gastrocnemius Cross-sectional area

  6 months

Study Arms (2)

Additional treatment with NMES after Achilles Tendon rupture

ACTIVE COMPARATOR

Neuromuscular electrical stimulation 2 times a day á 15 minutes during the week 3-8 after the Achilles Tendon rupture. Patients will also follow ordinary standard rehabilitation for Achilles Tendon rupture

Device: Neuromuscular electrical stimulation (NMES)

Control group

NO INTERVENTION

Patients will follow ordinary standard rehabilitation for Achilles Tendon rupture

Interventions

Neuromuscular electrical stimulation (NMES) DEVICE

Neuromuscular electrical stimulation (NMES) 2 times a day á 15 minutes from the third to the eight week after injury. The additional treatment will be perform in the patients home by themselves

Additional treatment with NMES after Achilles Tendon rupture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Achilles Tendon rupture
• The injury should have been treated within two days from the trauma
• The rupture is located in the mid portion of the tendon

You may not qualify if:

• Pregnancy
• Having a pace maker, intra cardiac defibrillator or other active implant
• Having had an Achilles Tendon rupture before, regardless of side
• Having an earlier injury that will have an impact on lower leg function, regardless of side
• Diabetes
• Neuro vascular disease
• Immunosuppressive treatment
• Difficulties to understand the language or difficulties in understand instructions.
• Unable to consent

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Forskningsenhet Ortopedi, Sahlgrenska universitetssjukhuset, Mölndal

Mölndal, VGregion, 43180, Sweden

RECRUITING

Study Officials

• Katarina Nilsson Helander, Ass.Prof

  VGregion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarina Nilsson Helander, Ass.prof.

CONTACT

+46 70-3218420; katarina.nilsson.helander@vgregion.se

Annelie Brorsson, Ass.prof

CONTACT

+46 70-4005508; annelie.brorsson@orthop.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 24, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)