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

NCT05520008 | Completed

• 1 other identifier: H-52182
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Extremity Swelling; Lower Extremity Edema; Venous Insufficiency of Leg

Keywords

Compression Garment; Game-based Exercise

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Change in foot volume from baseline to 4 weeks

  Foot volume will be assessed with a standard foot volumeter

  4 weeks from baseline

• 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 Outcomes (4)

• Change in gastrocnemius muscle strength from baseline to 4 weeks

  4 weeks from baseline

• Change in gait and balance from baseline to 4 weeks

  4 weeks from baseline

• Change in balance from baseline to 4 weeks

  4 weeks from baseline

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

  4 weeks from baseline

Other Outcomes (3)

• Change in peripheral neuropathy from baseline to 4 weeks

  4 weeks from baseline

• Patient acceptance at 4 weeks

  4 weeks from baseline

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

  4 weeks from baseline

Study Arms (2)

Active group (AG)

EXPERIMENTAL

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.

Other: Game-based exercise

Control group (CG)

NO INTERVENTION

Control Group (CG). The CG (n=15) will wear a compression garment for four weeks.

Interventions

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.

Also known as: Tele-exercise

Active group (AG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Medline Industries: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Officials

• Bijan Najafi, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with a ratio of 1:1 into two groups. Both groups will be given a compression garment (CompreCares, Medline, IL, USA) to wear for the 4 weeks of the study. The Active group (AG) will also be allocated a tablet and foot sensor so that they can play game-based foot \& ankle exercises during the same time period. The other group (Control group, CG) will only use the compression garment.

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: November 3, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)