Calcaneus Fractures, Flatfoot, Plantar Fasciitis
Conditions
Keywords
Range of Motion, Ankle Fractures, Elderly patients
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.
Detailed description
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.
Interventions
DEVICENon-Measuring Ankle Exerciser
Stretching exercise performed 10 times per day, for six (6) weeks.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * stiffness in or about the ankle joint due to age, diabetes, trauma, flatfoot, plantar fasciitis, or immobilization
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Range of Motion | Ten weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 3 |
Baseline characteristics
| Characteristic | Standard of Care or Ankle Exerciser |
|---|---|
| Age, Customized 18 years or older | 26 Participants |
| Sex/Gender, Customized Male and Female | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Ten weeks
Population: No participant data or results are available as the investigator left the institution without making them or any analysis available.