Lower Limb Amputation Below Knee (Injury)NCT06013631
Effects of Prosthesis Training on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees
A study testing Prosthesis Training and Phantom Exercises in people with Lower Limb Amputation Below Knee (Injury), run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Prosthesis Training and Phantom Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Prosthesis Training With and Without Phantom Exercises on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees
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.
Read the 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.
- Being tested
- Prosthesis Training, Phantom Exercises
- Keywords
- Phantom limb pain, Prosthesis, Prosthesis training, Prosthesis satisfaction
- Medical subject headings
- Wounds and Injuries, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthesis TrainingOther
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.
Phantom ExercisesOther
The phantom exercises involved visualizing and then trying to perform the movements of the phantom limb.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Prosthesis Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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').
Measured: 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.
Measured: Ambulation status will be observed at baseline and any change will be assessed at 6th week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Jan 2023
- Primary completion21 Aug 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashfaq Ahmad, PhD, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013631
- Sponsor's protocol ID
- REC-UOL-315-01-2023
- Status last verified
- Jan 2025
- First submitted
- 22 Aug 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants data that underlies the results after de-identification
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prosthesis Training With and Without Phantom Exercises on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees
- ClinicalTrials.gov ID
- NCT06013631
- Acronym / sponsor ID
- REC-UOL-315-01-2023
- Keywords
- Phantom limb pain, Prosthesis, Prosthesis training, Prosthesis satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phantom Exercises | Experimental | Other: Phantom ExercisesThe 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. |
| Prosthesis Training | Active comparator | Other: Prosthesis TrainingTraining 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Severe systematic illness
- Psychological issues
- Hearing/ visual impairment
- Malignancies
- Infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthesis TrainingTraining 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. | Other | Prosthesis Training |
| Phantom ExercisesThe phantom exercises involved visualizing and then trying to perform the movements of the phantom limb. | Other | Phantom Exercises |
Primary outcome
Prosthesis satisfaction level
Time frame: It 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 Intensity
Time frame: Pain 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 Status
Time frame: Ambulation 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. Participants data that underlies the results after de-identification
Related trials for Lower Limb Amputation Below Knee (Injury)
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
Recruiting
Restoration of Normative Postural Control
Lower Limb Amputation Below Knee (Injury)
Recruiting
Prosthetic Performance Enhancement Trial
Amputation, Lower Limb Amputation Below Knee (Injury)
Active, not recruitingObservational study
C-STAR Movement Database
Stroke, Parkinson Disease
Recruiting
An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
Lower Limb Amputation Below Knee (Injury), Diurnal Residual Limb Fluid Volume Fluctuation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashfaq Ahmad, PhD study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthesis Training and Phantom Exercises in people with Lower Limb Amputation Below Knee (Injury), run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis satisfaction level (time frame: It will be assessed at 6th week after the application of intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.