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Investigator left institution. No data analysis completed.
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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.
The purpose of this study is to assess how effective a new device is in increasing range of motion and reducing stiffness in the foot and ankle of patients with acquired flatfoot, patients with plantar fasciitis, and those suffering from stiffness after cast removal or other lengthy immobilization.
Project will utilize a physical therapist to measure range of motion and stiffness when patients are consented. Patients will be re-measured at six weeks following use of the device to assist in stretching ankle and foot muscles, and again at 10 weeks for final stiffness and range of motion assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Measuring Ankle Exerciser | Device | Stretching exercise performed 10 times per day, for six (6) weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saul G Trevino, MD | University of Missouri-Columbia School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia Healthcare | Columbia | Missouri | 65212 | United States |
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26 participants were enrolled. While we know the number who completed the study (23), we do not know to which group/arm they were assigned. There are no other recruitment details, study results or data available as the PI left the institution without making this information available to the research department.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care or Ankle Exerciser | Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Although 23 participants completed the study, we do not know their baseline characteristics or to which arm/group they were assigned as the investigator left the institution without making this information available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care or Ankle Exerciser | Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner: 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.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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No participant data or results are available as the investigator left the institution without making them or any analysis available. | Posted | Ten weeks |
|
10 weeks
Adverse event information not available as investigator left the institution without providing this information or making it available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care or Ankle Exerciser | 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.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner: 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. |
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No participant data were analyzed because the investigator left the institution before doing so. The results are unavailable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Saul G Trevino | University of Missouri | 573/884-8840 | trevinos@health.missouri.edu |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| D005413 | Flatfoot |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D000070558 | Talipes |
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| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D005531 |
| Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D005532 | Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |