Clinical Trial: Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT

Brief Summary:

Diabetic foot complications are a common and costly problem. Excessive plantar pressures due to foot deformities and/or limited ankle dorsiflexion, especially in the presence of peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers. Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot ulcers.

Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology) was effective in treating subjects with chronic heel pain and Achilles tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to perform more effective stretching exercises and may prevent recurrence of diabetic foot ulcers.

The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk subjects with a history of diabetic foot ulcer.


Detailed Summary:
Sponsor: Temple University

Current Primary Outcome:

  • Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks [ Time Frame: at baseline visit and at 4 weeks ]
  • Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks. [ Time Frame: at baseline visit and 4 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months. [ Time Frame: at 1 month and at 3 months ]
  • Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months. [ Time Frame: at 1 month and at 3 months ]


Original Secondary Outcome: Same as current

Information By: Temple University

Dates:
Date Received: August 28, 2014
Date Started: October 2014
Date Completion: October 2017
Last Updated: August 26, 2015
Last Verified: August 2015