Clinical trial NCT06387459: Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement
Official title: Safety and Feasibility of Knee Extensor Muscle-mimicking, Fabric-type Orthosis on Gait in Geriatric Patients: Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait
Fall
Orthotic Devices
Keywords: Geriatric patient
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and ICT, Republic of Korea
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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)
* Walking environment will include EMG (Electromyography) measurements, 6-minute walk test, 10-meter walk test, and comprehensive gait analysis using platforms like the GAITRite system.
* Seating environment will include EMG (Electromyography) measurements and TUG test. 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

Eligibility criteria: 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.

Primary outcomes:
measure: Completion Rate
timeFrame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
Secondary outcomes:
measure: Dropout Rate
timeFrame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
measure: User Feedback
timeFrame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
measure: 6-Minute Walk Test
timeFrame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
measure: 10-Meter Walk Test
timeFrame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
measure: Surface Electromyography
timeFrame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
measure: Gait Analysis
timeFrame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno
Study officials:
affiliation: Seoul National University Hospital
name: hyungik shin, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Woo Hyung Lee, prof
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Jung hyun Kim, prof
role: STUDY_DIRECTOR
References: