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Clinical Trials/CTRI/2026/01/102081
CTRI/2026/01/102081Not yet recruitingPhase 2/3

Effect of Agility Training on Quality of Life Among Unilateral Transtibial Amputees Using Prosthesis

MOHAMED AFZAL SARFRAZ H1 site in 1 country30 target enrollmentStarted: February 3, 2026Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1

Study Overview

Brief Summary

This study is a randomized , parallel group , active controlled trial evaluating the A total of 30 individuals, aged 18 -50 years and diagnosed with Unilateral transtibial amputee will be recruited from the Occupational Therapy And Orthopaedic Department at Chettinad Hospital and Mukti M.S. Dadha Foundation, meenambakam and Clinics in the Chengalpattu District. After obtaining consent and confirming inclusion criteria, participants will be randomly assigned into two groups: an intervention group (n = 15) and a control group (n = 15). Pre-intervention assessment of the independency will be conducted using the WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF (WHOQOL-BREF ).The experimental group will receive AGILITY TRAINING, while the Control Group will not receive any intervention by researcher during this time. Eg: Each session will last 45 minutes,3 days per week, for 4 weeks. After the 4-weeks intervention period, the independency will be reassessed using the same tools WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF (WHOQOL-BREF). Pre- and post-intervention scores will be statistically analysed to evaluate the effectiveness of the intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Unilateral transtibial below knee amputees.
  • First time prosthesis users.
  • Sound limb muscle strength grade more than 3 Manual Muscle Testing.
  • Ability to stand unsupported for at least 15 minutes.
  • Ability to walk a minimum of 15 steps using the prosthesis.
  • Age range: 18 to 50 years.
  • Able to understand and follow commands.
  • Those who has low balance confidence.

Exclusion Criteria

  • Presence of psychiatric conditions.
  • Sensory or motor impairments due to neurological disorders.
  • Perceptual disorders (e.g., visuospatial or cognitive–perceptual deficits).
  • Any other medical instability that could interfere with training.

Investigators

Sponsor
MOHAMED AFZAL SARFRAZ H
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

MOHAMED AFZAL SARFRAZ H

Chettinad academy of research and education

Study Sites (1)

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