Clinical trial NCT06013631: Effects of Prosthesis Training on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees
Official title: Effects of Prosthesis Training With and Without Phantom Exercises on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation Below Knee (Injury)
Keywords: Phantom limb pain
Prosthesis
Prosthesis training
Prosthesis satisfaction
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prosthesis satisfaction level
timeFrame: It will be assessed at 6th week after the application of intervention.
measure: Phantom Limb Pain Intensity
timeFrame: Pain intensity will be assessed at baseline and any change in pain intensity will be measured at 6th week of intervention.
measure: Ambulation Status
timeFrame: Ambulation status will be observed at baseline and any change will be assessed at 6th week of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Ashfaq Ahmad, PhD
role: STUDY_CHAIR
References: