Comparisons of sPace Dynamic Prosthetic foot with standard SACH foot in BK amputee

Phase 3

• Conditions: transtibial amputee; limb loss

• Registration Number: TCTR20210525003
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-25
• Study Completion: 2022-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. transtibial amputee age over or equal to 18 years.
2. Experience prosthetics user, using a standard SACH foot at least 4 hours per day for at least 6 months.
3. Have a Medicare functional classification level K2 - K4.
4. Be able to walk with prosthetic legs without a walking aid.
5. Consent to participate in research studies.

Exclusion Criteria

1. Have an underlying disease That affects the gait, such as neurological diseases Diseases of the musculoskeletal system Circulatory disease Respiratory disease
2. The normal leg has any kind of disability or deformity.
3. person who contraindicated for exercise.
4. Weighs more than 120 kg.
5. having a condition in which the stump is unable to use a prosthetic, such as a wound, inflammation, infection The stump is too short or too long.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
gait parameters 1 month gait analysis

Secondary Outcome Measures

Name	Time	Method
acclimation period 1 month VAS scale,satisfaction level 1 month VAS scale