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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
NCT06457659
Enrollment
50
Registered
2024-06-13
Start date
2023-11-01
Completion date
2024-10-30
Last updated
2024-06-13

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

Conditions

Amputation Stump

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.

Interventions

BEHAVIORALEarly 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.

OTHERDelayed 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.

Sponsors

Superior University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
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 were included

Exclusion criteria

* patients with comorbidities and old users of prostheses were excluded

Design outcomes

Primary

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

Countries

Pakistan

Outcome results

None listed

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