Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

NCT ID: NCT06631014

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Amputation of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early Rehab Group

Group Type EXPERIMENTAL

Early Rehab

Intervention Type DIAGNOSTIC_TEST

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

Delayed Rehab Group

Group Type ACTIVE_COMPARATOR

Delayed Rehab

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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Early Rehab

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

Intervention Type DIAGNOSTIC_TEST

Delayed 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients with comorbidities
* old user of prosthesis
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mobility Rehab care, Islamabad Medical Center, Near DHQ D.I.Khan

Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSRSW/Batch-Fall22/742

Identifier Type: -

Identifier Source: org_study_id

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