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

University of Lahore

Status: Completed

Conditions: Lower Limb Amputation Below Knee (Injury)

Treatments: Other: Prosthesis Training; Other: Phantom Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06013631

REC-UOL-315-01-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Phantom Exercises

Experimental group

Description:

The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb. 1. Place the limb at the angle at which they were sensing their phantom limb. 2. Put their healthy limb in the identical spot as they perceived their phantom limb. 3. Move their two limbs in opposition to one another. 4. 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. 5. Once the patient is at ease, movements like hip or knee flexion/extension are performed until the PLP is gone. 6. Phantom exercises will be performed as many times as possible in a single session up to 15 times until the PLP fully subsided.

Treatment:

Other: Phantom Exercises

Prosthesis Training

Active Comparator group

Description:

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.

Treatment:

Other: Prosthesis Training