Foot InjuryNCT02643524
Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
A study testing Nutrition and Exercise Counseling in people with Foot Injury and Ankle Injury, 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 walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Injury, Ankle Injury
- What is being tested?
- Nutrition and Exercise Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2015to 23 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18 (male or female)
- Participants prescribed a CAM boot as standard of care from the study investigator's practice
- Participant willing to have weight measured at the clinic site at time of enrollment and final visit
- Participants willing to have blood drawn for Albumin level at beginning and end of study
- Participant is able to provide voluntary, written informed consent
- Participant, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.
- Fluent in written and spoken English
Who cannot join
- Participants less than 18 years of age
- Pregnant women
- Cognitive impairment
- Participants with vertigo or other balance issues
- Participants unable to provide informed consent
- Non-English speaking individuals
- Participants who will not be wearing a CAM boot for at least 6 weeks
- Participants unable/unwilling to perform upper body exercises and follow nutrition guidelines
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 walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information.
Read the detailed description
The study objectives are: (1) Determine if patients wearing a CAM (Controlled Ankle Movement) walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercises (gender appropriate) information at the time the CAM boot is dispensed; and (2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period.
- Conditions
- Foot Injury, Ankle Injury
- Being tested
- Nutrition and Exercise Counseling, Control
- Keywords
- Adult, CAM boot, controlled ankle movement
- Medical subject headings
- Foot Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Exercise CounselingBehavioural
Patients are prescribed CAM boot and provided nutritional and upper body exercise counseling at the time the CAM boot is dispensed. Patients will be given a diary to complete their daily meal intake (optional), seated upper body physical exercise guidelines and asked to perform them three days per week and each exercise three times per session if able. They will be asked to record number of hours CAM boot is worn daily in the Patient Diary, if one is utilized. Albumin lab test will be drawn and their height and weight measured.
ControlBehavioural
Patients are prescribed CAM boot. No nutritional or exercise guidelines will be provided. Patients will be given a diary to complete their daily meal intake and physician exercise (if any) and number of hours CAM boot is worn daily. Albumin lab test will be drawn and their height and weight measured.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Exercise Counseling | Active comparator | CAM boot prescribed as standard of care Nutritional counseling provided Upper body exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit Patients in this arm compared with patients in control arm Receives: Behavioral: Nutrition and Exercise Counseling |
| Control | Active comparator | CAM boot prescribed as standard of care No nutritional or exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks.
Measured: Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks
Secondary outcomes (1)
Nutritional status (Pre- and post-albumin levels)
Pre- and post-albumin levels to measure protein and provide nutritional status
Measured: Enrollment through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start7 Dec 2015
- Primary completion9 Apr 2018
- Study completion23 May 2019
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot InjuryStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nell Blake, DPM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nell Blake, DPM, Milton S. Hershey Medical Center
- Investigators
- Nell Blake, DPM, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643524
- Sponsor's protocol ID
- IRB - 2324
- Status last verified
- Jun 2019
- First submitted
- 29 Dec 2015
- Last updated
- 28 Jun 2019
- 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 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
- ClinicalTrials.gov ID
- NCT02643524
- Acronym / sponsor ID
- IRB - 2324
- Conditions
- Foot Injury, Ankle Injury
- Keywords
- Adult, CAM boot, controlled ankle movement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nell Blake, DPMUniversity, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 31 Dec 2015 (estimated)
- 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 walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information.
Detailed description
The study objectives are: (1) Determine if patients wearing a CAM (Controlled Ankle Movement) walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercises (gender appropriate) information at the time the CAM boot is dispensed; and (2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Exercise Counseling | Active comparator | Behavioral: Nutrition and Exercise CounselingCAM boot prescribed as standard of care Nutritional counseling provided Upper body exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit Patients in this arm compared with patients in control arm |
| Control | Active comparator | Behavioral: ControlCAM boot prescribed as standard of care No nutritional or exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater or equal to 18 (male or female)
- Participants prescribed a CAM boot as standard of care from the study investigator's practice
- Participant willing to have weight measured at the clinic site at time of enrollment and final visit
- Participants willing to have blood drawn for Albumin level at beginning and end of study
- Participant is able to provide voluntary, written informed consent
Key exclusion criteria (8 listed)
- Participants less than 18 years of age
- Pregnant women
- Cognitive impairment
- Participants with vertigo or other balance issues
- Participants unable to provide informed consent
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 CounselingPatients are prescribed CAM boot and provided nutritional and upper body exercise counseling at the time the CAM boot is dispensed. Patients will be given a diary to complete their daily meal intake (optional), seated upper body physical exercise guidelines and asked to perform them three days per week and each exercise three times per session if able. They will be asked to record number of hours CAM boot is worn daily in the Patient Diary, if one is utilized. Albumin lab test will be drawn and their height and weight measured. | Behavioural | Nutrition and Exercise Counseling |
| ControlPatients are prescribed CAM boot. No nutritional or exercise guidelines will be provided. Patients will be given a diary to complete their daily meal intake and physician exercise (if any) and number of hours CAM boot is worn daily. Albumin lab test will be drawn and their height and weight measured. | Behavioural | Control |
Primary outcome
Weight change
Time frame: Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks
Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks.
1 secondary outcome
Nutritional status (Pre- and post-albumin levels)
Time frame: Enrollment through study completion, an average of 12 weeks.
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- 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
Milton S. 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 Counseling in people with Foot Injury and Ankle Injury, 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 7 inclusion and 8 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 28 Jun 2019. 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: Recruitment difficulties). 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: Enrollment through release by Doctor to discontinue CAM Boot, an average of 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 28 Jun 2019; AzTrials last refreshed its copy on 29 Oct 2026.