Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation

NCT05180682 | Completed

• 1 other identifier: KMU/IPMR/MS
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation

Keywords

Lower limb Amputation; Balance; Mobility

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Supervised

EXPERIMENTAL

This group training was supervised by the health care provider.

Other: Gait Training

Non-Supervised

ACTIVE COMPARATOR

This group was non-supervised.

Other: Gait Training

Interventions

Gait Training OTHER

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

Non-Supervised; Supervised

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age range 15-55 years.
• Both genders: (male and females).
• Trans-tibial amputation
• Patients involved in prosthetic rehabilitation (strengthening, balance training, stretching exercises and gait training).

You may not qualify if:

• Patient with cognitive problem.
• Infection
• Neuromas
• Limb swelling

Sponsors & Collaborators

• NCS University System: lead
• Khyber Medical University Peshawar: collaborator

Study Sites (1)

Pakistan Institute of Prosthetic and Orthotic Sciences, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Study Officials

• Hazrat Bilal, MSPT

  Khyber Medical University Peshawar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invistigator

Model Details: Participants were non randomly allocated to two groups and and were analyzed in the end of the study.

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: January 6, 2022
• Study Start: March 12, 2021
• Primary Completion: October 18, 2021
• Study Completion: October 23, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)