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

NCT ID: NCT06013631

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-09-07

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.

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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phantom Exercises

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.

Group Type: EXPERIMENTAL

Phantom Exercises

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Prosthesis Training

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Phantom Exercises

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashfaq Ahmad, PhD

Role: STUDY_CHAIR

University of Lahore

Locations

The University of Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC-UOL-315-01-2023

Identifier Type: -

Identifier Source: org_study_id