Effects of prosthetic socket fit and alignment adjustments on intra-socket pressure and gait motion.

UMIN ID: UMIN000055592

Registered date:25/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Trans tibial amputee
• Date of first enrollment: 2024/09/11
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The prosthetist adjusts the socket alignment for the individual amputee's prosthetic limb. There shall be a total of eight conditions: socket adduction angle (+/-), flexion angle (+/-), internal/external position (+/-), and anteroposterior position (+/-). Experimental measurements will be taken after the intervention and returned to normal alignment after completion.

Outcome(s)

• Primary Outcome: Evaluate the pressure in the prosthetic socket. The timing of the evaluation should be before and after the prosthetist performs the alignment intervention.
• Secondary Outcome: Evaluate kinematic and kinematic parameters during gait. The timing of the evaluation should be before and after the prosthetist performs the alignment intervention.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Those with orthopedic disease in the lower limb on the healthy side, those with bilateral amputation, and those who have difficulty walking with a prosthetic limb.

Related Information

• Primary Sponsor: Niigata University of Health and Welfare
• Source(s) of Monetary Support: Niigata University of Health and Welfare