Metatarsal Phalangeal Joint Deformity Progression - R01

NCT02616263 | Completed Results DMC

• 1 other identifier: DK107809
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the relationships between foot muscle, foot motion, and toe deformity. Results from this investigation will help the investigators to understand what contributes to foot deformities and the role of the foot muscles in the development of foot deformities. This could potentially guide treatment options focusing on strengthening the foot muscles to prevent or reduce the risk of developing a foot deformity.

Conditions

Diabetes Mellitus (DM)

Outcome Measures

Primary Outcomes (1)

• Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period

  The angle between the 2nd metatarsal and the proximal phalanx will be measured at baseline and again at the 3-years

  Three years

Study Arms (2)

Foot Intervention

EXPERIMENTAL

The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit.

Other: Foot exercise

Shoulder Intervention

ACTIVE COMPARATOR

Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion.

Other: Shoulder exercise

Interventions

Foot exercise OTHER

Foot Intervention

Shoulder exercise OTHER

Shoulder Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus (DM)
• Diabetic peripheral neuropathy

You may not qualify if:

• active plantar ulcers, unable to ambulate or complete required testing, anyone who have amputations of their lower extremity (\>1 toe), weigh more than 400 lbs, pregnant, have metal implants or pace makers (incompatible with MRI), greater than 75 years old, Subjects with other causes of PN (lumbar radiculopathy, microvascular disease, alcoholic/HIV/chemotaxic neuropathy), on dialysis, with peripheral arterial disease (ABI\<0.9 or \>1.3), with fixed MTPJ deformity (excursion \<30 degrees active/passive), acute shoulder pain or disability that would prevent participation in shoulder specific intervention (i.e. severe shoulder pain \>6/10, rotator cuff tear, upper extremity surgery, thoracic outlet syndrome);

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

Location

Related Publications (14)

• Harris-Hayes M, Schootman M, Schootman JC, Hastings MK. The Role of Physical Therapists in Fighting the Type 2 Diabetes Epidemic. J Orthop Sports Phys Ther. 2020 Jan;50(1):5-16. doi: 10.2519/jospt.2020.9154. Epub 2019 Nov 28.

  PMID: 31775555 BACKGROUND

• Hastings MK, Commean PK, Chen L, Zellers JA, Sinacore DR, Baker JC. Qualitative study of musculoskeletal tissues and their radiographic correlates in diabetic neuropathic foot deformity. Foot (Edinb). 2021 Jun;47:101777. doi: 10.1016/j.foot.2021.101777. Epub 2021 May 3.

  PMID: 33957525 BACKGROUND

• Holmes CJ, Hastings MK. The Application of Exercise Training for Diabetic Peripheral Neuropathy. J Clin Med. 2021 Oct 28;10(21):5042. doi: 10.3390/jcm10215042.

  PMID: 34768562 BACKGROUND

• Zellers JA, Commean PK, Chen L, Mueller MJ, Hastings MK. A limited number of slices yields comparable results to all slices in foot intrinsic muscle deterioration ratio on computed tomography and magnetic resonance imaging. J Biomech. 2021 Dec 2;129:110750. doi: 10.1016/j.jbiomech.2021.110750. Epub 2021 Sep 13.

  PMID: 34555631 BACKGROUND

• Zellers JA, Eekhoff JD, Walk RE, Hastings MK, Tang SY, Lake SP. Human Achilles tendon mechanical behavior is more strongly related to collagen disorganization than advanced glycation end-products content. Sci Rep. 2021 Dec 17;11(1):24147. doi: 10.1038/s41598-021-03574-4.

  PMID: 34921194 BACKGROUND

• Zellers JA, Mueller MJ, Commean PK, Chen L, Jeong HJ, Hastings MK. Multi-System Factors Associated with Metatarsophalangeal Joint Deformity in Individuals with Type 2 Diabetes. J Clin Med. 2020 Apr 3;9(4):1012. doi: 10.3390/jcm9041012.

  PMID: 32260124 RESULT

• Hastings MK, Jeong HJ, Sorensen CJ, Zellers JA, Chen L, Bohnert KL, Snozek D, Mueller MJ. Relationships within and between lower and upper extremity dysfunction in people with diabetes. Foot (Edinb). 2020 Sep;44:101680. doi: 10.1016/j.foot.2020.101680. Epub 2020 Mar 30.

  PMID: 32679515 RESULT

• Jeong HJ, Mueller MJ, Zellers JA, Hastings MK. Midfoot and ankle motion during heel rise and gait are related in people with diabetes and peripheral neuropathy. Gait Posture. 2021 Feb;84:38-44. doi: 10.1016/j.gaitpost.2020.11.013. Epub 2020 Nov 16.

  PMID: 33264731 RESULT

• Jeong HJ, Mueller MJ, Zellers JA, Yan Y, Hastings MK. Heel Rise and Non-Weight-Bearing Ankle Plantar Flexion Tasks to Assess Foot and Ankle Function in People With Diabetes Mellitus and Peripheral Neuropathy. Phys Ther. 2021 Jul 1;101(7):pzab096. doi: 10.1093/ptj/pzab096.

  PMID: 33735386 RESULT

• Zellers JA, Bernhardson HJ, Jeong HJ, Commean PK, Chen L, Mueller MJ, Hastings MK. Association of toe-extension movement pattern magnitude and variability during three functional tasks with diabetic foot complications. Clin Biomech (Bristol). 2021 May;85:105371. doi: 10.1016/j.clinbiomech.2021.105371. Epub 2021 May 3.

  PMID: 33965738 RESULT

• Jeong HJ, Mueller MJ, Zellers JA, Commean PK, Chen L, Hastings MK. Body mass index and maximum available midfoot motion are associated with midfoot angle at peak heel rise in people with type 2 diabetes mellitus and peripheral neuropathy. Foot (Edinb). 2022 May;51:101912. doi: 10.1016/j.foot.2022.101912. Epub 2022 Feb 11.

  PMID: 35255403 RESULT

• Jeong HJ, Cha B, Zellers JA, Chen L, Hastings MK. Midfoot and ankle movement coordination during heel rise is disrupted in people with diabetes and peripheral neuropathy. Clin Biomech (Bristol). 2022 Jun;96:105662. doi: 10.1016/j.clinbiomech.2022.105662. Epub 2022 May 7.

  PMID: 35569256 RESULT

• Bohnert KL, Zellers JA, Jeong HJ, Chen L, York A, Hastings MK. Remote Research: Resources, Intervention Needs, and Methods in People with Diabetes and Peripheral Neuropathy. J Diabetes Sci Technol. 2023 Jan;17(1):52-58. doi: 10.1177/19322968221103610. Epub 2022 Jun 30.

  PMID: 35770988 RESULT

• Youmans NJ, Vaidya RS, Chen L, Jeong HJ, York A, Commean PK, Hastings MK, Zellers JA. Rate of tarsal and metatarsal bone mineral density change in adults with diabetes mellitus and peripheral neuropathy: a longitudinal study. J Foot Ankle Res. 2023 Feb 13;16(1):6. doi: 10.1186/s13047-023-00606-2.

  PMID: 36782282 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

We excluded individuals with more severe foot deformity limiting generalizability of the study findings. There were some delays in final time point assessment and participant attrition due to Covid-19 related restrictions on human subjects research around the final time point

Results Point of Contact

• Title: Dr. Mary Hastings, Professor
• Organization: Washington University in St. Louis, School of Medicine, Program in Physical Therapy

hastingsmk@wustl.edu

3142107108

Study Officials

• Mary K Hastings, PT,DPT,MSCI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: March 1, 2016
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)