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

Sponsor

University of Lahore (Other)

Overall Status

Recruiting

CT.gov ID

NCT06013631

Collaborator

(none)

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Limb Amputation Below Knee (Injury)	Other: Prosthesis Training Other: Phantom Exercises	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The accessor will be unaware of treatment group.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Aug 21, 2023

Anticipated Study Completion Date :

Sep 7, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Prosthesis satisfaction level [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.
Phantom Limb Pain Intensity [Pain intensity will be assessed at baseline and any change in pain intensity will be measured at 6th week 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. 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.
Ambulation Status [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 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,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Lahore	Lahore	Punjab	Pakistan	5400

Sponsors and Collaborators

University of Lahore

Investigators

Study Chair: Ashfaq Ahmad, PhD, The University of Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Lahore

ClinicalTrials.gov Identifier:

NCT06013631

Other Study ID Numbers:

Fiza Komal

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Lahore

Phantom limb pain

Prosthesis

Prosthesis training

Prosthesis satisfaction

Study Results

No Results Posted as of Aug 28, 2023