Skip to main content
OpenTrials
Completed

NCT Number: NCT05520008

Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema

The present study aims to use a game-based tele-exercise program for patients using a compression garment to improve lower extremity edema. This tele-exercise gaming platform can work as an efficient exercise to improve patients' muscle strength. It also can be helpful in improving edema and venous return and can be used in addition to compression garments to increase efficacy. The sample size (n=30) is convenient and designed to explore acceptability and feasibility. Eligible participants will be screened at the Baylor college of Medicine Clinic based on the inclusion/exclusion criteria. Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. Both groups will receive a compression garment to use for 4 weeks, and in the intervention group, patients will receive a sensor and a tablet to play foot & ankle exercise games twice a day for 5 minutes. Study participation will be 4 weeks for all participants. Participants will be assessed in two visits: a baseline visit (BL) and a visit at the end of the 4 weeks (W4). The primary outcomes will be calf circumference, foot volume, and pitting edema grade. Secondary outcomes include limb strength, foot perfusion, gait assessment (gait speed, stride length, double stance, and gait steadiness), balance, and quality of life. The coordinator will monitor patients weekly to see their adherence to the compression garment and game-based exercise.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Extremity Swelling Lower Extremity Edema Venous Insufficiency of Leg

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

Lower extremity edema (LE) is an accumulation of interstitial fluid volume in the legs and feet and commonly occurs in patients with diabetes, hypertension, kidney disease, heart failure, cirrhosis, cancer, and obesity. LE can also result from deep vein thrombosis (DVT) in the lower leg. Compression socks or garments are often used to decrease this edema. Despite the efficacy of this treatment, there are some limitations including low patient compliance and contraindication of high compression levels for patients with high grades of peripheral arterial disease. Given that it is has previously been shown that exercise can be a positive way to reduce LE, the present study aims to use a game-based exercise program to help increase patient's movement and thus improve efficacy and adherence to the compression garments/socks.

The investigators will recruit 30 participants and randomly divide them into two groups: Active Group (AG) and Control Group (CG). Both groups will receive a compression garment (CompreCares) developed by Medline Incorporated(Inc). (IL, USA). The AG will receive a tablet and foot sensor (TEXASSENSE INC, USA), and will be instructed to play with it daily for 5 minutes over the period of 4 weeks.

During the two study visits (BL and W4), the investigators will assess the following outcomes: calf muscle activation (assessed by surface electromyography [sEMG]), foot perfusion (SNAPSHOT NIR, Kent Imaging System), calf and foot circumference, ankle-brachial index (ABI), pitting edema test, foot volume, gait, balance, and peripheral neuropathy (DPNCheck, Neurometrix Inc., Woburn, Massachusetts, USA).

Acceptability and patient reported outcomes will be assessed via validated questionnaires collected at each study visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (18+ years old) who have lower extremity edema
  • Willing to attend clinic for assessments

Exclusion criteria

  • Severe cognitive decline that reduces their ability to use tele-foot exercise device
  • Major visual problems that reduces their ability to use tele-foot exercise device
  • Inability to walk independently for a distance of 10 meters
  • Major foot problems such as active lower extremity wounds
  • Major foot deformity (e.g., Charcot Foot)
  • Previous major amputations, and claudication
  • Decompensated or advanced heart failure New York Heart Association (NYHA) Functional Class(FC) III-IV
  • Significant heart disease

Treatment and study plan

Game-based exercise

Other

Patients in the active group will put on a sensor connected to a tablet to play a game-based foot/ankle exercise twice a day for 5 minutes for four weeks.

Other names: Tele-exercise

Primary outcomes

  1. Change in calf circumference from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Calf circumference will be assessed with a soft measuring tape for each leg

  2. Change in foot circumference from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Foot circumference will be assessed with a soft measuring tape for each leg

  3. Change in foot volume from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Foot volume will be assessed with a standard foot volumeter

  4. Change in pitting edema grade from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Coordinators will press on the affected area in the lower extremities and measure depth of indention. They will record the length of skin rebound time and grade the edema based on validated scales

Secondary outcomes

  1. Change in gastrocnemius muscle strength from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Lower extremity strength will be assessed with an ankle dynamometer and surface electromyography (Delsys Trigno Wireless EMG System, MA, US).

  2. Change in gait and balance from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Gait speed will be measured with standard walking tests and wearable sensors (Legsys).

  3. Change in balance from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Static balance will be measured with standard balance tests and wearable sensors (Balansens).

  4. Change in plantar tissue oxygen saturation/consumption from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Percentage of tissue oxygen saturation (SatO2) and hemoglobin values will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 and level in superficial tissue. The area that will be captured is the metatarsus area

Other outcomes

  1. Change in peripheral neuropathy from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Peripheral neuropathy will be assessed using DPNCheck (Neurometrix, Woburn, MA, USA). This is a noninvasive device which will measure conduction velocity and amplitude.

  2. Patient acceptance at 4 weeks

    Time frame: 4 weeks from baseline

    Participant acceptance of the tele-exergaming program will be assessed at the end of their participation using a validated technology acceptance model (TAM) questionnaire

  3. Change in physical activity (step count and intensity minutes) from baseline to 4 weeks

    Time frame: 4 weeks from baseline

    Physical activity metrics, such as step count and intensity minutes, will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Medline Industries

Registry information

Official study title

A Game-based Foot & Ankle Exercise Program to Increase Efficacy Of Compression Garments At Managing Edema

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.