NCT01856972

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

May 14, 2013

Last Update Submit

June 10, 2014

Conditions

Keywords

Limited Dorsiflexion Range of MotionGastrocnemius tightnessSoleus tightness

Outcome Measures

Primary Outcomes (1)

  • Change in Weight bearing dorsiflexion Range of Motion

    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)

Study Arms (3)

Instrument Assisted Soft Tissue Mobilization

EXPERIMENTAL

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 MobilizationOther: Static stretching/ROM exercises

Rearfoot joint mobilization

EXPERIMENTAL

Subjects randomized into this treatment arm will receive a rear-foot joint mobilization as well as a standard stretching/ROM protocol

Procedure: Rearfoot joint mobilizationOther: Static stretching/ROM exercises

Static stretching/ROM exercises

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: IASTM, SASTM
Instrument Assisted Soft Tissue 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.

Also known as: Talocrural caudal thrust mobilization, Talocrural manipulation
Rearfoot joint mobilization

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.

Instrument Assisted Soft Tissue MobilizationRearfoot joint mobilizationStatic stretching/ROM exercises

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital Sports and Orthopedic PT East Broad St location

Columbus, Ohio, 43213, United States

Location

Related Publications (8)

  • Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.

    PMID: 22666642BACKGROUND
  • Fong CM, Blackburn JT, Norcross MF, McGrath M, Padua DA. Ankle-dorsiflexion range of motion and landing biomechanics. J Athl Train. 2011 Jan-Feb;46(1):5-10. doi: 10.4085/1062-6050-46.1.5.

    PMID: 21214345BACKGROUND
  • Piva SR, Fitzgerald GK, Wisniewski S, Delitto A. Predictors of pain and function outcome after rehabilitation in patients with patellofemoral pain syndrome. J Rehabil Med. 2009 Jul;41(8):604-12. doi: 10.2340/16501977-0372.

    PMID: 19565153BACKGROUND
  • Radford JA, Burns J, Buchbinder R, Landorf KB, Cook C. Does stretching increase ankle dorsiflexion range of motion? A systematic review. Br J Sports Med. 2006 Oct;40(10):870-5; discussion 875. doi: 10.1136/bjsm.2006.029348. Epub 2006 Aug 22.

    PMID: 16926259BACKGROUND
  • Hammer WI. The effect of mechanical load on degenerated soft tissue. J Bodyw Mov Ther. 2008 Jul;12(3):246-56. doi: 10.1016/j.jbmt.2008.03.007. Epub 2008 Jun 3.

    PMID: 19083680BACKGROUND
  • Schaefer JL, Sandrey MA. Effects of a 4-week dynamic-balance-training program supplemented with Graston instrument-assisted soft-tissue mobilization for chronic ankle instability. J Sport Rehabil. 2012 Nov;21(4):313-26. doi: 10.1123/jsr.21.4.313.

    PMID: 23118072BACKGROUND
  • Fryer GA, Mudge JM, McLaughlin PA. The effect of talocrural joint manipulation on range of motion at the ankle. J Manipulative Physiol Ther. 2002 Jul-Aug;25(6):384-90. doi: 10.1067/mmt.2002.126129.

    PMID: 12183696BACKGROUND
  • Bozymski EM, Isaacs KL. Special diagnostic and therapeutic considerations in elderly patients with upper gastrointestinal disease. J Clin Gastroenterol. 1991;13 Suppl 2:S65-75. doi: 10.1097/00004836-199112002-00009.

    PMID: 1885904BACKGROUND

Study Officials

  • Mitchell C Selhorst, MPT

    Nationwide Children's Hospital

    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
Physical Therapist

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 20, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations