Foot and Ankle Range of Motion (Stretching) Apparatus

NCT00527748 | Terminated Results

• 1 other identifier: 1092357
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Range of motion at ankle joint and subtalar joint will be assessed before and after utilization of ARM device. The changes in range of motion will be recorded and compared to literature.

Conditions

Plantar Fasciitis; Flatfoot; Calcaneus Fractures

Keywords

Range of Motion; Ankle Fractures; Elderly patients

Outcome Measures

Primary Outcomes (1)

• Change in Range of Motion

  Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.

  Ten weeks

Study Arms (2)

Standard of care

NO INTERVENTION

Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.

Non-Measuring Ankle Exerciser

EXPERIMENTAL

Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks. Reassessment will be done at six weeks and 10 weeks.

Device: Non-Measuring Ankle Exerciser

Interventions

Non-Measuring Ankle Exerciser DEVICE

Stretching exercise performed 10 times per day, for six (6) weeks.

Also known as: Ankle Recovery Mechanism (ARM)

Non-Measuring Ankle Exerciser

Eligibility Criteria

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

You may qualify if:

• years of age or older
• stiffness in or about the ankle joint due to age, diabetes, trauma, flatfoot, plantar fasciitis, or immobilization

You may not qualify if:

• not physically able to use device
• patients with pain disorders
• patients lacking necessary hand-eye coordination
• patients using lower extremity external fixator
• patients with history of non-compliance

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia Healthcare

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Flatfoot; Ankle Fractures

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Limitations and Caveats

No participant data were analyzed because the investigator left the institution before doing so. The results are unavailable.

Results Point of Contact

• Title: Dr. Saul G Trevino
• Organization: University of Missouri

trevinos@health.missouri.edu

573/884-8840

Study Officials

• Saul G Trevino, MD

  University of Missouri-Columbia School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2012
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)