Ankle InjuriesCAMNCT05692401
Weight Change With Controlled Ankle Movement (CAM) Boot Use
A study testing Nutrition and Exercise Instruction in people with Ankle Injuries and Foot Injuries and Disorders, run by Nell Blake, DPM at 1 site in United States.
Trial summary
The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Ankle Injuries, Foot Injuries and Disorders, Body Weight Changes
- What is being tested?
- Nutrition and Exercise Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18 years
- Participants with foot or ankle injury who are prescribed a CAM boot as standard of care
- Participants willing to have height and weight measured at the time of enrollment and final visit
- Participant is able to provide voluntary, written consent
- Fluent in written and spoken English
- Participant in the opinion of the Principal Investigator, is able to understand the clinical investigation
Who cannot join
- Age less than 18 years
- Pregnant women
- Participants with vertigo or other balance issues
- Participants unable to provide informed consent
- Participants with foot or ankle injury who will not be wearing a CAM boot
- Participants unable/unwilling to perform upper body exercises and follow nutrition recommendations
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.
Read the detailed description
The study objectives include: 1) Determine if patients wearing a CAM (Controlled Ankle Movement) boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines at the time the CAM is dispensed and perform upper body exercises through the treatment period. 2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) To qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when CAM boot is used
- Being tested
- Nutrition and Exercise Instruction
- Keywords
- controlled ankle movement, CAM boot
- Medical subject headings
- Ankle Injuries, Foot Injuries, Disease, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Exercise InstructionBehavioural
Eating and exercise patterns. Educational handouts and instructions will be provided, which are intended as a guide for subjects in intervention group. Subjects will also be given a Patient Diary to complete their daily meal intake and physical exercises. Use of and return of the diary is optional but encouraged. It has been found that use of a patient diary to record food intake keeps one from eating more than they planned and can be a useful tool in weight control.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | CAM boot prescribed as standard of care. No nutritional guidelines or upper body exercises instructions provided. Height and weight recorded at enrollment and final visit. |
| Nutrition and Exercise Instruction | Active comparator | CAM prescribed as standard of care. Nutritional guidelines provided and upper body exercise instructions provided. Height and weight recorded at enrollment and final visit. Subjects in this group will undergo a follow up interview that will ultimately be used to examine and assess the helpfulness of the intervention in preventing weight for CAM boot wearing patients. Receives: Behavioral: Nutrition and Exercise Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Height and weight recorded at enrollment and discontinuation of CAM boot
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start7 Jun 2023
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Why it stopped: Study recruitment stopped due to recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nell Blake, DPM
- Sponsor type
- University, hospital or other
- Collaborators
- Milton S. Hershey Medical Center
- Responsible party
- Sponsor-investigator, Nell Blake, DPM, Milton S. Hershey Medical Center
- Investigators
- Nell Blake, DPM, Principal investigator, Penn State Health Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692401
- Sponsor's protocol ID
- STUDY 00021093
- Acronym
- CAM
- Status last verified
- Jul 2025
- First submitted
- 11 Jan 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Change With Controlled Ankle Movement (CAM) Boot Use
- ClinicalTrials.gov ID
- NCT05692401
- Acronym / sponsor ID
- CAM / STUDY 00021093
- Keywords
- controlled ankle movement, CAM boot
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study recruitment stopped due to recruitment problems
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nell Blake, DPMUniversity, hospital or other
- Collaborators
- Milton S. Hershey Medical Center
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.
Detailed description
The study objectives include: 1) Determine if patients wearing a CAM (Controlled Ankle Movement) boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines at the time the CAM is dispensed and perform upper body exercises through the treatment period. 2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) To qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when CAM boot is used
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –CAM boot prescribed as standard of care. No nutritional guidelines or upper body exercises instructions provided. Height and weight recorded at enrollment and final visit. |
| Nutrition and Exercise Instruction | Active comparator | Behavioral: Nutrition and Exercise InstructionCAM prescribed as standard of care. Nutritional guidelines provided and upper body exercise instructions provided. Height and weight recorded at enrollment and final visit. Subjects in this group will undergo a follow up interview that will ultimately be used to examine and assess the helpfulness of the intervention in preventing weight for CAM boot wearing patients. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater or equal to 18 years
- Participants with foot or ankle injury who are prescribed a CAM boot as standard of care
- Participants willing to have height and weight measured at the time of enrollment and final visit
- Participant is able to provide voluntary, written consent
- Fluent in written and spoken English
Key exclusion criteria (6 listed)
- Age less than 18 years
- Pregnant women
- Participants with vertigo or other balance issues
- Participants unable to provide informed consent
- Participants with foot or ankle injury who will not be wearing a CAM boot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and Exercise InstructionEating and exercise patterns. Educational handouts and instructions will be provided, which are intended as a guide for subjects in intervention group. Subjects will also be given a Patient Diary to complete their daily meal intake and physical exercises. Use of and return of the diary is optional but encouraged. It has been found that use of a patient diary to record food intake keeps one from eating more than they planned and can be a useful tool in weight control. | Behavioural | Nutrition and Exercise Instruction |
Primary outcome
Weight change
Time frame: 12 weeks
Height and weight recorded at enrollment and discontinuation of CAM boot
Results and safety
The study was stopped early (reason given: Study recruitment stopped due to recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nell Blake, DPM principal investigator
Penn State Health Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Exercise Instruction in people with Ankle Injuries and Foot Injuries and Disorders, run by Nell Blake, DPM at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study recruitment stopped due to recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 29 Oct 2026.