Does the Addition of Manual Therapy Techniques Increase Gastrocnemius/Soleus Length More Than Stretching Alone?

June 10, 2014 updated by: Mitchell Selhorst, Nationwide Children's Hospital

This study will examine the short term effects of adding manual therapy techniques to static stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2 forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument assisted soft tissue mobilization (IASTM). By comparing 3 groups: TJM+static stretching versus IASTM + static stretching versus static stretching alone the investigators wish to see if there are any short term benefits in DF ROM by adding either of these interventions to static stretching.

The manual therapy treatment will occur over 2 sessions and DF ROM measurements will be taken 4 times over a 2 week period.

The population that the investigators wish to examine are subjects with healthy feet and ankles, but with limited DF ROM.

The primary objective of this study is to see if subjects with decreased dorsiflexion motion will experience greater increases in dorsiflexion motion with the addition of manual therapy of static stretching alone.

Our hypothesis is subjects who receive manual therapy therapy and static stretching will experience a significant increase in DF ROM as compared to subjects who receive static stretching alone. More specifically subjects who are treated with the IASTM will experience greater results than subjects who are treated with the rear-foot thrust mobilization.

Study Overview

Status

Status

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Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Actual)

Enrollment

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20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Nationwide Children's Hospital Sports and Orthopedic PT East Broad St location

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

healthy feet and ankles must have limited dorsiflexion ROM. Limited dorsiflexion will be judged by patient having <12 degrees of DF PROM with knee extended, or <50 degrees of weight bearing DF ROM with the knee flexed.

Exclusion Criteria:

  • inability to fully weight bear through their lower extremities
  • have <0-90 degrees of ROM in their knees
  • inability to follow directions
  • presence of a Lower Extremity fracture
  • pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Instrument Assisted Soft Tissue Mobilization
Subjects randomized into this treatment arm will receive Instrument Assisted Soft Tissue Mobilization to the Gastrocnemius/Soleus complex, as well as a standard stretching/ROM protocol
Procedure: Instrument Assisted Soft Tissue Mobilization
IASTM treatment: will be performed with the sound assisted soft tissue mobilization tool #5. Patient will be placed in the prone position with the ankle in a relaxed position. The treating therapist will perform 10 scanning strokes in the caudal, cephalic, medial, lateral directions for a total of 40 strokes over the Gastrocnemius/Soleus complex. The therapist can then perform more concentrated strokes in areas noted by the therapist as tight, with a maximum treatment time of 5 minutes.
Other Names:
  • IASTM
  • SASTM
Other: Static stretching/ROM exercises
Gastrocnemius stretch at wall 3 sets of 30 second holds. Soleus stretch at wall 3 sets of 30 second holds. Standing bilateral dorsiflexion on step x30 with full ROM. Standing bilateral plantar flexion on step x30 with full ROM.
Experimental: Rearfoot joint mobilization
Subjects randomized into this treatment arm will receive a rear-foot joint mobilization as well as a standard stretching/ROM protocol
Other: Static stretching/ROM exercises
Gastrocnemius stretch at wall 3 sets of 30 second holds. Soleus stretch at wall 3 sets of 30 second holds. Standing bilateral dorsiflexion on step x30 with full ROM. Standing bilateral plantar flexion on step x30 with full ROM.
Procedure: Rearfoot joint mobilization
A high velocity-low amplitude distractive thrust is directed at the talocrural joint. The procedure is performed with the patient in the supine position. The therapist interlaces hands over the dorsum of the foot with 5th digit placed on talus. The therapist slightly pronates and dorsiflexes the foot. Tension is taken up in a caudal direction until the soft tissue barrier is engaged. A distractive thrust is then applied. This is performed up to 2 times. If the therapist notes a cavitation, the patient is progressed to ROM exercises. If there is no cavitation is noted by the therapist the thrust mobilization is reapplied.
Other Names:
  • Talocrural caudal thrust mobilization
  • Talocrural manipulation
Active Comparator: Static stretching/ROM exercises
This is the control group consisting of Static stretching/ROM exercises. No manual intervention is performed with the group. The subjects will perform the standard stretching and ROM protocol
Other: Static stretching/ROM exercises
Gastrocnemius stretch at wall 3 sets of 30 second holds. Soleus stretch at wall 3 sets of 30 second holds. Standing bilateral dorsiflexion on step x30 with full ROM. Standing bilateral plantar flexion on step x30 with full ROM.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Weight bearing dorsiflexion Range of Motion
Time Frame: Immediately prior to treatment, Immediately following treatment (same day), 2 day follow up visit,and at 2 weeks (12-16 days after initial session)
Subjects will perform 3 practice range of motion (ROM) before the first measurement is taken. Subjects will then be measured for Dorsiflexion range of motion with knee in full extension and then with knee flexed 3 times each. With each measurement subjects will be instructed to bend the ankle forward as far as possible without their heel leaving the ground. The average value for these 3 measurements will be calculated and that will be the subjects DF ROM measurement. The change in ROM at each measurement will be the outcome we are measuring
Immediately prior to treatment, Immediately following treatment (same day), 2 day follow up visit,and at 2 weeks (12-16 days after initial session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nationwide Children's Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

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  • IRB13-00096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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