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

Effects of Prosthesis Training With and Without Phantom Exercises 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.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Amputation Below Knee (Injury)
• Intervention / Treatment: Other: Phantom Exercises; Other: Prosthesis Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiza Komal, MS; Phone Number: +923317681871; Email: drfiza.komal@gmail.com
• Study Contact Backup: Name: Ayesha Jamil, M.Phil; Phone Number: +923244481031; Email: ayesha.jamil@uipt.uol.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 5400
      • Recruiting
      • The University of Lahore
      • Contact: Fiza Komal, MS; Phone Number: +923317681871; Email: drfiza.komal@gmail.com
      • Contact: Ayesha Jamil, M.Phil; Phone Number: +923244481031; Email: ayesha.jamil@uipt.uol.edu.pk
      • Principal Investigator: Fiza Komal, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Severe systematic illness
2. Psychological issues
3. Hearing/ visual impairment
4. Malignancies
5. Infectious disease
6. Neuropathic pain except PLP and residual limb pain
7. Any disorder that restricts movement of opposed limb, limited range of motion in sound limb
8. Taking pain relief medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phantom Exercises; The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.; Place the limb at the angle at which they were sensing their phantom limb.; Put their healthy limb in the identical spot as they perceived their phantom limb.; Move their two limbs in opposition to one another.; Go back to where they started. The movements included ankle inversion and eversion, flexion and extension, and adduction and abduction with toe flexion and extension, respectively.; Once the patient is at ease, movements like hip or knee flexion/extension are performed until the PLP is gone.; Phantom exercises will be performed as many times as possible in a single session up to 15 times until the PLP fully subsided.	Other: Phantom Exercises; The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.
Active Comparator: Prosthesis Training; 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 rotation, Stepping on multiple heights and positions, Tandem walk, within parallel bar, and weight shifting. Gait training will last six weeks in total.	Other: Prosthesis Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthesis satisfaction level	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.	It will be assessed at 6th week after the application of intervention.
Phantom Limb Pain Intensity	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. visual analogue scale (VAS) can be used to aid someone to assess the strength of particular moods and experiences, such as pain. The visual analogue scale for pain is a conventional, with the lowest likely discomfort at one end and no pain at the other.	Pain intensity will be assessed at baseline and any change in pain intensity will be measured at 6th week of intervention.
Ambulation Status	. The Amputee Mobility Predictor (AMP) analyses an amputee's movement with or without a prosthesis in order 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 assistive device is included) and AMPPRO 0-38 (43 if assistive device is included). Higher scores indicate better mobility,	Ambulation status will be observed at baseline and any change will be assessed at 6th week of intervention.

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Study Chair: Ashfaq Ahmad, PhD, The University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): August 21, 2023
• Study Completion (Estimated): September 7, 2023

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Prosthesis; Phantom limb pain; Prosthesis training; Prosthesis satisfaction
• Other Study ID Numbers: Fiza Komal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participants data that underlies the results after de-identification
• IPD Sharing Time Frame: Immediately after publication
• IPD Sharing Access Criteria: Researchers who provide methodological sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No