EVALUATION of QUALITY of LIFE, PSYCHOSOCIAL ADAPTATION, and FUNCTIONALITY in SILICONE PROSTHESIS USERS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Nottingham Health Profile (NHP)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
silicone hand or finger prosthesis users
The first arm of our study consisted of participants with partial or finger amputation and silicone hand-finger prosthesis.
Intervention: silicone hand or finger prosthesis (Device)
silicone foot or toe prostheses users
The second arm of our study consisted of participants with partial or finger amputation and silicone foot-foot toe prosthesis.
Intervention: silicone foot and foot toe prosthesis (Device)
Outcomes
Primary Outcomes
Nottingham Health Profile (NHP)
Time Frame: through study completion, an average of 1 year
The NHP questionnaire consists of two sections with "Yes-No" responses. The first section includes dimensions such as energy levels, pain, emotional reactions, sleep, social isolation, and physical abilities, while the second section addresses the impact of poor health on daily life, covering areas such as employment, household activities, social life, relationships, sexual life, hobbies, and vacations. The first section's total score ranges from 0-600, with higher scores indicating lower activity. The second section ranges from 0-7, with higher scores indicating lower activity.
Trinity Amputation and Prosthesis Experience Scales (TAPES)
Time Frame: through study completion, an average of 1 year
The TAPES questionnaire evaluates psychosocial adaptation, functionality, and prosthesis satisfaction. It comprises two main sections with nine subscales. The psychosocial subscales include general adaptation, social adaptation, and restriction adaptation, with each rated on a five-point scale (1: Strongly Disagree to 5: Strongly Agree). Scores range from 5 to 25, with higher scores indicating better adaptation.
Visual Analog Scale(VAS)
Time Frame: through study completion, an average of 1 year
The VAS was used to measure pain in the stump before and after silicone prosthesis use. They were asked to draw their pain level on a 10 cm scale between 0-10 points as 0=no pain, 10 unbearable pain
Secondary Outcomes
No secondary outcomes reported
Investigators
ESRA ATILGAN
Assoc.Prof.Dr.
Medipol University