Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

Not Applicable

Active, not recruiting

• Conditions: Amputation of Knee
• Interventions: Diagnostic Test: Early Rehab; Combination Product: Delayed Rehab

• Registration Number: NCT06631014
• Lead Sponsor: Superior University

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.

Detailed Description

Delayed rehabilitation may cause severe physical complications like joint contracture, muscle strength loss. Along with physical complications delayed in rehabilitation may also significantly affect psychological, economical and quality of daily life. Pakistan is a low income under developed country and major cause of amputation in here is traumatic amputation, that will effect mostly the younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be effected. There is a keen need of implementation of global rules for physical rehabilitation of amputees and disables including the duration of induction of prosthetic as well as overall physical rehabilitation after surgical and traumatic removal of limbs.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-05-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male and female below-knee amputees due to trauma and diabetes

Exclusion Criteria

• patients with comorbidities
• old user of prosthesis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Rehab Group	Early Rehab	-
Delayed Rehab Group	Delayed Rehab	-

Primary Outcome Measures

Name	Time	Method
World Health Organization Quality of life (WHO QOL)	12 Months	questionnaire was used to measure the impact in both groups for quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centres, 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 are assessed separately in WHO_QOL known as 4 domains of questionaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain.

Trial Locations

Locations (1)

Mobility Rehab care, Islamabad Medical Center, Near DHQ D.I.Khan; 🇵🇰 Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan