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CompletedNCT05180682Updated Oct 5, 2022

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

An interventional study of Gait Training in Amputation, sponsored by NCS University System. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by NCS University System · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2021, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
15 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Amputation

Keywords

  • Lower limb Amputation
  • Balance
  • Mobility
03

In context

Lead sponsor

NCS University System is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Patient with cognitive problem.
  2. Infection
  3. Neuromas
  4. Limb swelling
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Supervised

    This group training was supervised by the health care provider.

    Other: Gait Training

  • Active comparator
    Non-Supervised

    This group was non-supervised.

    Other: Gait Training

Interventions

  • OtherGait 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One month

  2. 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

    Time frame: One month

07

Study locations

1 site
  • Pakistan Institute of Prosthetic and Orthotic Sciences, Peshawar
    Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05180682
Lead sponsor
NCS University System
Collaborators
Khyber Medical University Peshawar
Responsible party
Dr. Hazrat Bilal PT (Principal Invistigator, Khyber Medical University Peshawar) — Principal investigator
First posted
Jan 6, 2022
Start date
Mar 12, 2021
Primary completion
Oct 18, 2021
Completion
Oct 23, 2021
Last update
Oct 5, 2022

Study contacts

Hazrat Bilal, MSPT
principal investigator · Khyber Medical University Peshawar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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