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Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06631014
Enrollment
50
Registered
2024-10-08
Start date
2023-11-01
Completion date
2024-12-31
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation of Knee

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.

Interventions

DIAGNOSTIC_TESTEarly Rehab

The first group of 25 Patients was fitted with Prosthesis with in 6months of duration after amputation.

COMBINATION_PRODUCTDelayed Rehab

The 2nd group of 25 patients that was fitted with Prosthesis after the time period of 6months after amputation. No physical rehab was done during this time period including physiotherapy and prosthetic treatment. Main aim was to check the significant impact of delayed rehabilitation.

Sponsors

Superior University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* patients with comorbidities * old user of prosthesis

Design outcomes

Primary

MeasureTime frameDescription
World Health Organization Quality of life (WHO QOL)12 Monthsquestionnaire 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026