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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05180682
Other study ID # KMU/IPMR/MS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2021
Est. completion date October 23, 2021

Study information

Verified date October 2022
Source NCS University System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It was quasi experimental study where the researchers assess the effectiveness of supervised training program on mobility and balance confidence in individual with lower limb amputation.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 23, 2021
Est. primary completion date October 18, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years to 55 Years
Eligibility Inclusion Criteria: 1. Age range 15-55 years. 2. Both genders: (male and females). 3. Trans-tibial amputation 4. Patients involved in prosthetic rehabilitation (strengthening, balance training, stretching exercises and gait training). Exclusion Criteria: 1. Patient with cognitive problem. 2. Infection 3. Neuromas 4. Limb swelling

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gait Training
the physical therapist will provide different protocol at different weeks in the following way. first week: first fitting and initial Gait training second week: Specific Gait Training third week: Advance Gait Training fourth week: Functional Training

Locations

Country Name City State
Pakistan Pakistan Institute of Prosthetic and Orthotic Sciences, Peshawar Peshawar Khyber Pakhtunkhwa

Sponsors (2)

Lead Sponsor Collaborator
NCS University System Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Balance confidence Balance was assessed through Activity-specific balance confidence. Its a 16-item questionnaire where patients' rate their confidence while doing activities.
Scoring from 0-100 (0 is no confidence and 100 is full confidence) Paper survey, 5-10 mins for administration. No Training required.
One month
Primary Mobility Mobility was assessed through loco-motor capabilities index. The loco-motor capabilities index is a disease-specific, self-administered instrument for assessing locomotor abilities generally considered essential for basic and advanced ADLs of people with lower-limb amputation and an enabling factor associated with long-term prosthetic use. It is easily administered and quickly completed.
It is composed of 14 questions The LCI can be divided into two 7-item subscales that cover basic (items 1, 4, 5, 8-11) and advanced (items 2, 3, 6, 7,12-14) activities, respectively. Higher scores reflect greater locomotor capabilities with the prosthesis and less dependence on assistance. Maximum score = 56, Minimum score = 0
One month
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