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

Lower Limb Amputation Below Knee (Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013631
• Other study ID #: Fiza Komal
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 7, 2023

Study information

• Verified date: August 2023
• Source: University of Lahore
• Contact: Fiza Komal, MS
• Phone: +923317681871
• Email: drfiza.komal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 7, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation Below Knee (Injury)

Intervention

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

Locations

Country	Name	City	State
Pakistan	The University of Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.