← Back to Search

Game-based exercise for Lower Leg Swelling

N/A
Waitlist Available
Led By Bijan Najafi, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks from baseline
Awards & highlights

Study Summary

This trial is testing whether a game-based tele-exercise program can help improve lower extremity edema for patients who wear compression garments. The study will last for 4 weeks, and participants will be assessed at the beginning and end of the trial.

Eligible Conditions
  • Lower Leg Swelling
  • Lower Extremity Edema
  • Chronic Venous Insufficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in calf circumference from baseline to 4 weeks
Change in foot circumference from baseline to 4 weeks
Change in foot volume from baseline to 4 weeks
+1 more
Secondary outcome measures
Change in balance from baseline to 4 weeks
Change in gait and balance from baseline to 4 weeks
Change in gastrocnemius muscle strength from baseline to 4 weeks
+1 more
Other outcome measures
Change in peripheral neuropathy from baseline to 4 weeks
Change in physical activity (step count and intensity minutes) from baseline to 4 weeks
Patient acceptance at 4 weeks

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active group (AG)Experimental Treatment1 Intervention
Active group (AG). The AG (n=15) will play game-based foot and ankle exercises via a mobile application on a tablet. They will be asked to wear a foot sensor that is connected to the tablet during the exercise. They will be asked to play the game for 5-minutes, daily. They will do this in conjunction with wearing a compression garment for a period of 4 weeks.
Group II: Control group (CG)Active Control1 Intervention
Control Group (CG). The CG (n=15) will wear a compression garment for four weeks.

Find a Location

Who is running the clinical trial?

Medline IndustriesIndustry Sponsor
45 Previous Clinical Trials
23,022 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,001,933 Total Patients Enrolled
Bijan Najafi, PhDPrincipal InvestigatorBaylor College of Medicine
8 Previous Clinical Trials
642 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there slots open for participants in this trial?

"Clinicaltrials.gov affirms that this trial, which was initially advertised on November 1st 2022 and recently updated on October 11th of the same year, is not currently accepting participants. However, 119 other medical investigations are recruiting volunteers at present."

Answered by AI

What is the primary objective of this experiment?

"This medical trial will last for 4 weeks and aims to investigate changes in calf circumference, gastrocnemius muscle strength, gait speed/balance as measured with a dynamometer and wearable sensors, and plantar tissue oxygen saturation/consumption. To measure these objectives accurately the study uses an ankle dynamometer (Delsys Trigno Wireless EMG System), Legsys technology, and Snapshot NIR camera (KENT Imaging Inc.)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Baylor College of Medicine: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema
Bijan Najafi, PhD 2022. "Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05520008.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top