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Orthosis
Malleo-Lok for Acute Lymphoblastic Leukemia (MalleoLokStiff Trial)
N/A
Waitlist Available
Led By Jason M Wilken, PT, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes).
Awards & highlights
MalleoLokStiff Trial Summary
This trial is testing whether a commercial ankle-foot device impacts how users walk and the overall stiffness of their joints.
Eligible Conditions
- Acute Lymphoblastic Leukemia
- Healthy Subjects
MalleoLokStiff Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants were asked to rate their pain after completing in-vivo ankle stiffness testing and walking trials in all conditions.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants were asked to rate their pain after completing in-vivo ankle stiffness testing and walking trials in all conditions.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ankle Joint Moment
Ankle Joint Power
Ankle Joint Stiffness
Secondary outcome measures
Modified Socket Comfort Score: Comfort
Modified Socket Comfort Score: Smoothness
Numerical Pain Rating Scale
Other outcome measures
Center of Pressure Velocity Magnitude
Center of Pressure Velocity Timing
Medial Gastrocnemius Muscle Activity (Electromyography)
+3 moreMalleoLokStiff Trial Design
6Treatment groups
Experimental Treatment
Group I: Stiff, NoCDO, CompliantExperimental Treatment1 Intervention
Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant).
Group II: Stiff, Compliant, NoCDOExperimental Treatment1 Intervention
Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO).
Group III: NoCDO, Stiff, CompliantExperimental Treatment1 Intervention
Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant).
Group IV: NoCDO, Compliant, StiffExperimental Treatment1 Intervention
Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff).
Group V: Compliant, Stiff, NoCDOExperimental Treatment1 Intervention
Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO).
Group VI: Compliant, NoCDO, StiffExperimental Treatment1 Intervention
Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Malleo-Lok
2021
N/A
~20
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
446 Previous Clinical Trials
879,482 Total Patients Enrolled
Jason M Wilken, PT, PhDPrincipal InvestigatorUniversity of Iowa
11 Previous Clinical Trials
328 Total Patients Enrolled
Frequently Asked Questions
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