Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation
1 other identifier
interventional
50
1 country
1
Brief Summary
A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedJune 13, 2024
June 1, 2024
6 months
June 10, 2024
June 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
World Health Organization Quality of life (WHO QOL)
Questionnaire was used to measure the impact in both groups on quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality-of-life assessment that would be applicable cross-culturally. The patient's physical, psychological, social, and environmental state of health is assessed separately in WHO\_QOL known as the 4 domains of the questionnaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health about the respective domain.
12 Months
Study Arms (2)
Early Rehab Group
EXPERIMENTALDelayed Rehab Group
OTHERInterventions
The first group of 25 Patients was fitted with Prosthesis with in 6months of duration after amputation. The basic theme was to check the physical psychological and QOL in early prostheic-fitted patients through WHO\_QOL.
The 2nd group of 25 patients was fitted with Prosthesis after 6 months after amputation. No physical rehab was done during this period including physiotherapy and prosthetic treatment. The main aim was to check the significant impact of delayed rehabilitation.
Eligibility Criteria
You may qualify if:
- Male and female below-knee amputees due to trauma and diabetes were included
You may not qualify if:
- patients with comorbidities and old users of prostheses were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mobility Rehab care, Islamabad Medical Center
Dera Ismail Khan, Khyber Pakhtunkhwa, Pakistan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 13, 2024
Study Start
November 1, 2023
Primary Completion
May 1, 2024
Study Completion
October 30, 2024
Last Updated
June 13, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share