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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06013631
Enrollment
50
Registered
2023-08-28
Start date
2023-01-01
Completion date
2023-09-07
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

Phantom limb pain, Prosthesis, Prosthesis training, Prosthesis satisfaction

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.

Interventions

OTHERProsthesis 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.

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

Sponsors

University of Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The accessor will be unaware of treatment group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prosthesis satisfaction levelIt 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 IntensityPain intensity will be assessed at baseline and any change in pain intensity will be measured at 6th week of intervention.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').
Ambulation StatusAmbulation 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 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026