Real-time Motion Capture and Visual Feedback for Amputation Gait Training

NCT ID: NCT07049198

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-07-31

Brief Summary

People with transfemoral amputation face challenges such as gait asymmetry, instability, and increased energy consumption due to loss of the knee joint. Because of the loss of proprioceptive feedback from their missing limbs, visual feedback is essential for gait correction. Additionally, current visual feedback systems lack portability, cost-effectiveness, and they fail to provide precise, intuitive feedback on spatiotemporal parameters, joint angles, and both frontal and sagittal plane information, limiting their effectiveness in correcting gait abnormalities.This study aims to investigate whether gait training using a real-time 2D motion capture and visual feedback gait training system (2DMV) can improve the gait biomechanics and psychosocial functions of people with unilateral transfemoral amputation (uTFA). The 2DMV system analyzes spatiotemporal parameters and joint kinematics during gait and displays the uTFA's image on a screen, providing visual feedback specifically targeting gait abnormalities. This allows individuals with uTFA to intuitively understand the feedback and make real-time gait adjustments. The biomechanical parameters include joint kinematics, gait symmetry, and walking performance.

Conditions

Unilateral Transfemoral Amputation; Unilateral Knee Disarticulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Real-time 2D motion capture and visual feedback system gait training group (VF)

The VF group, the 2D motion capture and visual feedback training group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of visual feedback gait training using the 2DMV system.

Group Type: EXPERIMENTAL

Real-time 2D motion capture and visual feedback system gait training

Intervention Type: DEVICE

The difference between the VF group and the PT group lies in the use of real-time visual feedback during gait training; the VF group receives real-time visual feedback, while the PT group undergoes gait training without visual feedback.

Conventional physical therapy group (PT)

The PT group, the conventional physical therapy group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of gait training without the use of the 2DMV system for visual feedback. During gait training, the therapist provided standard gait correction feedback typically used in conventional physical therapy.

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy group

Intervention Type: OTHER

Ten minutes of strength training followed by thirty minutes of gait training, during which the 2DMV system is not used to provide visual feedback. During the gait training, the therapist provides gait correction feedback typically used in conventional physical therapy.

Interventions

Real-time 2D motion capture and visual feedback system gait training

The difference between the VF group and the PT group lies in the use of real-time visual feedback during gait training; the VF group receives real-time visual feedback, while the PT group undergoes gait training without visual feedback.

Intervention Type: DEVICE

Conventional physical therapy group

Ten minutes of strength training followed by thirty minutes of gait training, during which the 2DMV system is not used to provide visual feedback. During the gait training, the therapist provides gait correction feedback typically used in conventional physical therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years
• Individuals with unilateral transfemoral amputation or knee disarticulation
• Wear a prosthesis for at least 3 hours per day
• Have been using a prosthesis for more than 6 months
• Medicare Functional Classification Level (K-level) of 2 or above
• Able to walk independently for 5 meters without assistive devices
• No pain caused by poor prosthetic fit
• Montreal Cognitive Assessment Taiwan Version (MoCA-T) score ≥ 26

Exclusion Criteria

• Uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension)
• Cardiopulmonary or cardiovascular diseases (e.g., heart failure, severe asthma)
• History of neurological conditions that affect movement (e.g., stroke, spinal cord injury, cerebellar injury)
• Vestibular disorders
• Severe osteoporosis
• Other musculoskeletal injuries or open wounds
• Epilepsy
• Uncorrected visual impairments
• Congenital limb deficiency

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Hui-Ting Shih

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Yang Ming Chiao Tung University

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Hui-Ting Shih

Role: CONTACT

huiting.shih@nycu.edu.tw

+886 921 078 256

Facility Contacts

Hui-Ting Shih, PT, PhD

Role: primary

huiting.shih@nycu.edu.tw

+886-921078256

Other Identifiers

NYCU114067AE

Identifier Type: -

Identifier Source: org_study_id