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Completed

NCT Number: NCT06013631

Effects of Prosthesis Training on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees

The objective of the study is to assess the effects of prosthesis training with and without phantom exercises on pain, prosthesis satisfaction and ambulatory status of lower limb amputees treated with prosthesis training, phantom exercises and routine physical therapy.

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Key information

Conditions

Lower Limb Amputation Below Knee (Injury) Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore

Lahore, Punjab Province, 5400, Pakistan

About this study

Amputation is a catastrophic incident in a person's life which resulted in psychological, social and physical consequences. Loss of extremity resulted in negative impact on patient's body and perception as well. Phantom limb pain (PLP) can be defined by discomfort or pain in lost part of limb experienced by lower limb amputees. Phantom limb pain is physically and mentally draining condition which affects patient's daily activities like personal care and functional independence.

Phantom limb pain is highly prevalent condition among lower limb amputees. It is associated with negative effect on mental and physical health conditions. There are studies conducted on prosthesis training for prosthesis satisfaction.

However, according to researcher knowledge effects of prosthesis training along with phantom exercises have not been measured on prosthesis satisfaction. This study will encourage future studies on this topic and will help in developing state of art treatment of phantom limb discomfort associated with lower limb subtraction. As managing phantom discomfort can result in better prosthesis satisfaction and eventually ease the ambulatory status of patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-60 years
  • Gender: male/female
  • Unilateral lower limb amputees (trans-femoral, trans-tibial) and using prosthesis and having phantom limb pain will be included.
  • Limb deficiency and phantom limb questionnaire was used for screening of patients

Exclusion criteria

  • Severe systematic illness
  • Psychological issues
  • Hearing/ visual impairment
  • Malignancies
  • Infectious disease
  • Neuropathic pain except PLP and residual limb pain
  • Any disorder that restricts movement of opposed limb, limited range of motion in sound limb
  • Taking pain relief medications

Treatment and study plan

Prosthesis Training

Other

Training for prostheses at the appropriate amputation level will be provided. Conventional gait training protocols include Tandem walk, within parallel bar, controlled environment, full length Mirror on one side, weight shifting, shifting onto the Prosthetic Side, Pelvic 22 rotation, Stepping on multiple heights and positions, Tandem walk, within parallel bar, and weight shifting. Gait training will last six weeks in total.

Phantom Exercises

Other

The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.

Primary outcomes

  1. Prosthesis satisfaction level

    Time frame: It will be assessed at 6th week after the application of intervention.

    To check prosthesis satisfaction of the amputees, Trinity Amputation and Prosthesis Experience Scales (TAPES) will be used. It assesses prosthetic satisfaction on the basis of the functional, aesthetic, and weight subscales. TAPES evaluates how well people adjust to physical limitations that may have an impact on social behavior.Scores range from 5 to 25, with higher scores indicating greater levels of adjustment.

  2. Phantom Limb Pain Intensity

    Time frame: Pain intensity will be assessed at baseline and any change in pain intensity will be measured at 6th week of intervention.

    To measure pain intensity, Visual Analog Scale (VAS) will be used. VAS consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be').

  3. Ambulation Status

    Time frame: Ambulation status will be observed at baseline and any change will be assessed at 6th week of intervention.

    The Amputee Mobility Predictor (AMP) analyses an amputee's movement with or without a prosthesis to determine their potential for ambulation. A rapid and simple-to-use assessment instrument called the Amputee Mobility Predictor (AMP) was used to estimate the functional condition of lower-limb amputees both with and without the use of a prosthesis. AMPPRO 0-42 (47 if the assistive device is included) and AMPPRO 0-38 (43 if the assistive device is included). Higher scores indicate better mobility.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Effects of Prosthesis Training With and Without Phantom Exercises on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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