Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation

Not Applicable

Active, not recruiting

• Conditions: Amputation Stump
• Interventions: Other: Delayed Rehab Group; Behavioral: Early Rehab Group

• Registration Number: NCT06457659
• 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. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.

Detailed Description

Along with physical complications delays in rehabilitation may also significantly affect psychological, economic, and quality of daily life. Pakistan is a low-income developed country and the major cause of amputation here is traumatic amputation, which affects mostly 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 affected. There is a keen need for the implementation of global rules for physical rehabilitation of amputees and disabled including the duration of induction of prosthetics 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: 2024-06
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Completion: 2024-10-30

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

• patients with comorbidities and old users of prostheses were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

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 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.

Trial Locations

Locations (1)

Mobility Rehab care, Islamabad Medical Center; 🇵🇰 Dera Ismail Khan, Khyber Pakhtunkhwa, Pakistan