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

Venous Insufficiency of Leg Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520008
• Other study ID #: H-52182
• Status: Completed
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: October 6, 2023

Study information

• Verified date: November 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Lower Extremity Edema
• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

Other:
• Game-based exercise
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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in peripheral neuropathy from baseline to 4 weeks	Peripheral neuropathy will be assessed using DPNCheck (Neurometrix, Woburn, MA, USA). This is a noninvasive device which will measure conduction velocity and amplitude.	4 weeks from baseline
Other	Patient acceptance at 4 weeks	Participant acceptance of the tele-exergaming program will be assessed at the end of their participation using a validated technology acceptance model (TAM) questionnaire	4 weeks from baseline
Other	Change in physical activity (step count and intensity minutes) from baseline to 4 weeks	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)	4 weeks from baseline
Primary	Change in calf circumference from baseline to 4 weeks	Calf circumference will be assessed with a soft measuring tape for each leg	4 weeks from baseline
Primary	Change in foot circumference from baseline to 4 weeks	Foot circumference will be assessed with a soft measuring tape for each leg	4 weeks from baseline
Primary	Change in foot volume from baseline to 4 weeks	Foot volume will be assessed with a standard foot volumeter	4 weeks from baseline
Primary	Change in pitting edema grade from baseline to 4 weeks	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	4 weeks from baseline
Secondary	Change in gastrocnemius muscle strength from baseline to 4 weeks	Lower extremity strength will be assessed with an ankle dynamometer and surface electromyography (Delsys Trigno Wireless EMG System, MA, US).	4 weeks from baseline
Secondary	Change in gait and balance from baseline to 4 weeks	Gait speed will be measured with standard walking tests and wearable sensors (Legsys).	4 weeks from baseline
Secondary	Change in balance from baseline to 4 weeks	Static balance will be measured with standard balance tests and wearable sensors (Balansens).	4 weeks from baseline
Secondary	Change in plantar tissue oxygen saturation/consumption from baseline to 4 weeks	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	4 weeks from baseline