Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Enrolling by invitation NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT04839497 - Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. Phase 2
Recruiting NCT04212299 - Transfemoral Socket Design and Muscle Function N/A
Completed NCT03733054 - Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
Completed NCT03651830 - A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT04936789 - Clinical Feasibility of the IMES Transradial Prosthesis N/A
Completed NCT01155024 - Clinical Evaluation of Direct Manufactured Prosthetic Sockets Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Recruiting NCT00388752 - Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation Phase 1
Active, not recruiting NCT03374319 - Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations N/A
Completed NCT05542901 - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees N/A
Completed NCT05161364 - Kinetic Analysis Due to Foot Dysfunction
Recruiting NCT06194838 - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees N/A
Completed NCT03570788 - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Completed NCT05778799 - Physical Activity and Sports for People With Special Needs
Recruiting NCT04804150 - Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System N/A
Terminated NCT03259386 - Movement and Sensation for Advanced Prosthetic Hands