Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

Safety and Feasibility of Knee Extensor Muscle-mimicking, Fabric-type Orthosis on Gait in Geriatric Patients: Pilot Clinical Trial

This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation.

Study Overview

• Status: Not yet recruiting
• Conditions: Fall; Gait; Orthotic Devices
• Intervention / Treatment: Device: Fabric-Type Knee Extensor Muscle-Mimicking Orthosis

Detailed Description

Objectives:

• Primary Objective: To evaluate the safety and feasibility of the fabric-type knee extensor muscle-mimicking orthosis in improving gait among elderly patients.
• Secondary Objectives: To measure changes in walking speed, endurance, and muscle activity to infer potential benefits in daily mobility.

Study Design:

• Study Population: 30 elderly patients suffering from conditions affecting mobility (sarcopenia, diabetes, knee osteoarthritis).
• Intervention: Use of a fabric-type orthosis mimicking knee extensor function, equipped with shape-memory alloy for dynamic movement support.

• Methodology:

  1. Training and Adaptation: Participants will undergo an initial training session to get accustomed to the orthosis, including donning and doffing, adjustment, and use in various environments (flat surfaces, inclines).
  2. Assessment Protocol:
• Before wearing the orthosis-after wearing the orthosis (power off)-after wearing the orthosis (power on)
• Assessments will include EMG (Electromyography) measurements, 6-minute walk test, 10-meter walk test, and comprehensive gait analysis using platforms like the GAITRite system. 3. Safety Monitoring: Continuous monitoring of physiological responses (blood pressure, heart rate), musculoskeletal assessments, and skin integrity checks to monitor for adverse reactions or discomfort.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JungHyun Kim, prof; Phone Number: 82+1088632341; Email: kiking0@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Eligibility for participation in the study requires that all the following criteria are met:

1. Age: Participants must be 65 years of age or older.
2. Comprehension and Compliance: Able to fully understand and comply with the instructions and study procedures.

3. Mobility-Impacting Conditions: Must have at least one of the following conditions affecting mobility: (1)Sarcopenia:

   • Muscle Strength: Handgrip strength of <28 kg for men and <18 kg for women.
   • Muscle Function: Short Physical Performance Battery (SPPB) score of 8 or less.
   • Muscle Mass: Bioelectrical impedance analysis (BIA) showing muscle mass <7.0 kg/m² for men and <5.7 kg/m² for women. (2)Diabetes:
   • Diagnosed distal symmetric polyneuropathy.
   • Sensory impairments in toes or feet. (3)Knee Osteoarthritis:
   • Kellgren-Lawrence grade ≥2.
   • Persistent pain (≥3 months) with a severity of at least 3 on the Numerical Rating Scale (NRS).

Exclusion Criteria:

Individuals meeting any of the following criteria will be excluded from study participation:

1. Inability to Consent: Unable to provide informed consent or not willing to participate in the study procedures.
2. Severe Sensory or Motion Limitations: Including severe visual or vestibular impairments that could increase the risk of falling.
3. Communication Barriers: Significant hearing, speech, or language problems that would hinder communication with study personnel.
4. Independent Walking Inability: Cannot walk independently without the aid of a walking device.

5. Other Significant Diseases or Conditions:

   • Neurological disorders that affect walking ability (e.g., stroke, Parkinson's disease).
   • Orthopedic or musculoskeletal conditions severely affecting lower limb function.
   • Severe cardiovascular conditions including uncontrolled hypertension or heart failure.
   • Respiratory diseases requiring regular oxygen therapy.
   • Active cancer treatment or cancer treatment within the past 3 years (except basal cell carcinoma or localized prostate cancer).
   • Severe psychiatric disorders like schizophrenia or bipolar disorder.

6. Other Exclusionary Factors:

   • Past severe orthopedic surgeries on lower limbs which might affect gait and mobility.
   • Severe back pain or any other condition affecting mobility not already listed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Knee Extensor Muscle-Mimicking Orthosis; This arm involves participants wearing a novel, lightweight fabric-type orthosis designed to mimic the function of knee extensor muscles through embedded shape-memory alloys. This intervention aims to support the knee joint during gait, enhancing stability and mobility for elderly individuals with compromised muscle function.

Device: Fabric-Type Knee Extensor Muscle-Mimicking Orthosis; The intervention device is a fabric-based orthosis incorporating shape-memory alloy springs designed to mimic the action of knee extensor muscles. The primary function of this orthosis is to provide supplementary support to the knee joint during walking, aiming to stabilize the gait of elderly individuals affected by muscle weakness or degenerative joint conditions. Material: The orthosis is made from a lightweight, flexible fabric that allows for breathability and comfort during extended wear. Mechanism: Embedded within the fabric are shape- memory alloy springs that function similarly to biological muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate	The proportion of participants who complete the study as per the protocol, which indicates the orthosis's acceptability and the study's overall manageability.	1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dropout Rate	Measures participant retention throughout the study, providing insights into the orthosis's usability and participant satisfaction.	1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
User Feedback	Collected using the Quebec User Evaluation of Satisfaction with assistive Technology 2.0 (QUEST 2.0), which will cover aspects such as the orthosis's comfort, ease of use, safety, and effectiveness. This feedback is vital for understanding user satisfaction and for guiding future improvements.	1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
6-Minute Walk Test	To measure the distance covered in six minutes as a test of aerobic capacity and endurance, which may improve with the use of the orthosis.	1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
10-Meter Walk Test	To assess changes in basic walking speed over a short distance, reflecting potential improvements in mobility.	1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
Surface Electromyography	To evaluate muscle activity patterns that indicate the orthosis's impact on muscle engagement during gait.	1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
Gait Analysis	Using tools like the GAITRite system to obtain detailed measurements of gait cycle characteristics, providing comprehensive insights into the functional improvements afforded by the orthosis.	1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Science and ICT
• Investigators: Study Director: Jung hyun Kim, prof, Seoul National University Hospital; Principal Investigator: hyungik shin, prof, Seoul National University Hospital; Study Director: Woo Hyung Lee, prof, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): May 14, 2025
• Study Completion (Estimated): May 14, 2026

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Geriatric patient
• Other Study ID Numbers: 2022M3C1A3090827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No