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Evaluation of Individuals with Partial or Finger Amputation After Silicone Prosthesis Use

M

Medipol University

Status

Completed

Conditions

Psychosocial Adaptation
Quality of Life
Functionality
Silicone Prosthesis
Amputation

Treatments

Device: silicone foot and foot toe prosthesis
Device: silicone hand or finger prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT06874582
E-10840098-772.02-5247

Details and patient eligibility

About

Objective: This study aimed to evaluate the psychosocial adaptation, functional capacity, and quality of life of individuals who underwent partial hand or foot amputations after using silicone hand and foot prostheses.

Materials and Methods: The study included 32 patients. Demographic and clinical characteristics of the participants were recorded. Participants were divided into two groups as silicone hand or foot prosthesis users. The Visual Analog Scale (VAS) was used to assess pain levels before and after prosthesis use, the Trinity Amputation and Prosthesis Experience Scales (TAPES) were applied to evaluate functional capacity, and the Nottingham Health Profile (NHP) was used to assess quality of life.

Enrollment

32 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hand and foot amputation.
  • Aged between 18 and 60 years
  • Active employee
  • Able to walk, co-operate, move actively with hands
  • Who have been using prosthesis for at least 1 year and have good stump-socket compatibility,
  • Literate individuals were determined on a voluntary basis.

Exclusion criteria

  • Multiple amputations
  • Severe neurological or traumatic findings
  • Individuals with severe deformity or posture disorder that may lead to loss of gait, balance or function.
  • With limitation of movement in the upper extremities

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

silicone hand or finger prosthesis users
Active Comparator group
Description:
The first arm of our study consisted of participants with partial or finger amputation and silicone hand-finger prosthesis.
Treatment:
Device: silicone hand or finger prosthesis
silicone foot or toe prostheses users
Active Comparator group
Description:
The second arm of our study consisted of participants with partial or finger amputation and silicone foot-foot toe prosthesis.
Treatment:
Device: silicone foot and foot toe prosthesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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