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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01856972
Other study ID # IRB13-00096
Secondary ID
Status Completed
Phase N/A
First received May 14, 2013
Last updated June 10, 2014
Start date May 2013
Est. completion date June 2014

Study information

Verified date June 2014
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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:
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.

Locations

Country Name City State
United States Nationwide Children's Hospital Sports and Orthopedic PT East Broad St location Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Aug 22. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
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