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

Amputation Stump Clinical Trial

Official title:

Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06457659
• Other study ID #: MSRSW/Batch-Fall22/728
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: June 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation Stump
• Seizures

Intervention

Behavioral:
• Early Rehab Group
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.

Other:
• Delayed Rehab Group
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.

Locations

Country	Name	City	State
Pakistan	Mobility Rehab care, Islamabad Medical Center	Dera Ismail Khan	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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