Does Instrument-assisted Mobilization Influence Healthy, Short Achilles Tendons?

NCT07075172 | Completed

• 1 other identifier: BaylissRCT1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if instrumented-assisted soft tissue mobilization (i.e., massage using specialized metal instruments) of the lower leg and Achilles tendon region changes the properties of the tendon and the range of ankle dorsiflexion (i.e., the ability to bring the foot and toes back towards the head). One lower leg and Achilles tendon in each participant will be treated with instrumented-assisted soft tissue mobilization for 7 minutes during 8 treatment sessions over a 4-week period. The other lower leg and Achilles tendon will not be treated and be assessed as the non-treated control leg.

Conditions

Healthy; Achilles Tendon Length and Thickness

Outcome Measures

Primary Outcomes (2)

• Change in the stiffness of the Achilles tendon measured using ultrasound

  Participants will push their foot against a force measuring platform. At the same time, an ultrasound will be used to image their Achilles tendon. How much force they generated will be divided by how far the tendon stretches to indicate stiffness in newtons per millimeter (N/mm)

  From enrollment until 6 days after the end of treatment at 4 weeks

• Change in the modulus of the Achilles tendon measured using ultrasound

  Participants will push their foot against a force measuring platform. At the same time, an ultrasound will be used to image their Achilles tendon. How much force they generated will be divided by how far the tendon stretches to indicate stiffness in newtons per millimeter (N/mm). The stiffness will be divided by the cross sectional area of the tendon to indicate modulus in megaPascals (MPa).

  From enrollment until 6 days after the end of treatment at 4 weeks

Secondary Outcomes (1)

• Range of motion of ankle dorsiflexion

  From enrollment until 6 days after the end of treatment at 4 weeks

Study Arms (2)

IASTM treated

EXPERIMENTAL

Leg treated with instrument-assisted soft tissue mobilization

Other: Instrumented-assisted soft tissue mobilization

Non-treated

NO INTERVENTION

Non-treated leg

Interventions

Instrumented-assisted soft tissue mobilization OTHER

Instrumented-assisted soft tissue mobilization of the posterior leg and Achilles tendon region

IASTM treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The distance from the tip of the great toe to the wall during the weightbearing lunge test is \<90 mm bilaterally with ≤15 mm asymmetry
• A stretch sensation is reported in the region of the Achilles tendon during the weightbearing lunge test

You may not qualify if:

• A history of Achilles tendon injury, pain, rupture or surgery
• Current pain in the heel, foot or ankle
• Surgery in the past 12 months to the foot, heel or ankle
• A sensation other than a stretch within the Achilles tendon region during the weightbearing lunge test (e.g. compression/pinching in the vicinity of the anterior talocrural joint or a more vague, deeper stretch within the vicinity of the posterior talocrural joint).

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Indianapolis

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Stuart Warden

  Indiana University Indianapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical therapy

Model Details: Within-subject controlled study. One side of the body is treated with the other side being an internal non-treated control site.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 20, 2025
• Study Start: October 3, 2013
• Primary Completion: October 16, 2014
• Study Completion: October 16, 2014
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months after the publication of results with no end date.
• Access Criteria: Individuals can contact the investigators in writing to complete a data use agreement. Once approved by an institutional signing official, individual participant data will be provided.

Locations

US (1)