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

NCT06013631 | Completed DMC

• 1 other identifier: REC-UOL-315-01-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

Phantom limb pain; Prosthesis; Prosthesis training; Prosthesis satisfaction

Outcome Measures

Primary Outcomes (3)

• 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 measure pain intensity, Visual Analog Scale (VAS) will be used. VAS consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be').

  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 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 the assistive device is included) and AMPPRO 0-38 (43 if the 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.

Study Arms (2)

Phantom Exercises

EXPERIMENTAL

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.

Other: Phantom Exercises

Prosthesis Training

ACTIVE COMPARATOR

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

Interventions

Prosthesis Training 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.

Prosthesis Training

Phantom Exercises OTHER

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

Phantom Exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 5400, Pakistan

Location

MeSH Terms

Conditions

Wounds and Injuries; Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Ashfaq Ahmad, PhD

  University of Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The accessor will be unaware of treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: January 1, 2023
• Primary Completion: August 21, 2023
• Study Completion: September 7, 2023
• Last Updated: April 2, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after publication
• Access Criteria: Researchers who provide methodological sound proposal

Locations

PA (1)