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

Comparisons of gait analysis in transtibial amputee using prosthesis with the foot component of sPace Dynamic Prosthetic foot compare with standard SACH foot, a pilot match paired study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210525003
Enrollment
10
Registered
2021-05-25
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

transtibial amputee transtibial amputee limb loss

Interventions

S pace dynamic foot unit for BK prosthesis, use in daily activity for 1 month,standard foot unit for BK prosthesis in Thailand. patient use in daily activity more than 1 month
Experimental Device,Active Comparator Device
S-pace dynamic foot unit,SACH foot

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
gait parameters 1 month gait analysis

Secondary

MeasureTime frame
acclimation period 1 month VAS scale,satisfaction level 1 month VAS scale

Countries

Thailand

Contacts

Public ContactPattarapol yotnuengnit

faculty of medicine, Chulalongkorn University

yotnuengnitpmr@gmal.com022564433

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026