Amputation of KneeNCT06631014
Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation
A study testing Early Rehab and Delayed Rehab in people with Amputation of Knee, run by Superior University at 1 site in Pakistan.
Trial summary
A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Amputation of Knee
- What is being tested?
- Early Rehab and Delayed Rehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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
- Male and female below-knee amputees due to trauma and diabetes
Who cannot join
- patients with comorbidities
- old user of prosthesis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mobility Rehab care, Islamabad Medical Center, Near DHQ D.I.Khan
Dera Ismāīl Khān, Khyber Pakhtunkhwa
About this study
A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation.
Read the detailed description
Delayed rehabilitation may cause severe physical complications like joint contracture, muscle strength loss. Along with physical complications delayed in rehabilitation may also significantly affect psychological, economical and quality of daily life. Pakistan is a low income under developed country and major cause of amputation in here is traumatic amputation, that will effect mostly the younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be effected. There is a keen need of implementation of global rules for physical rehabilitation of amputees and disables including the duration of induction of prosthetic as well as overall physical rehabilitation after surgical and traumatic removal of limbs.
- Conditions
- Amputation of Knee
- Being tested
- Early Rehab, Delayed Rehab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early RehabDiagnostic test
The first group of 25 Patients was fitted with Prosthesis with in 6months of duration after amputation.
Delayed RehabCombination product
The 2nd group of 25 patients that was fitted with Prosthesis after the time period of 6months after amputation. No physical rehab was done during this time period including physiotherapy and prosthetic treatment. Main aim was to check the significant impact of delayed rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Early Rehab Group | Experimental | Not described Receives: Diagnostic Test: Early Rehab |
| Delayed Rehab Group | Active comparator | Not described Receives: Combination Product: Delayed Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of life (WHO QOL)
questionnaire was used to measure the impact in both groups for quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. The patient's physical, psychological, social, and environmental state of health are assessed separately in WHO_QOL known as 4 domains of questionaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of KneeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631014
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/742
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation
- ClinicalTrials.gov ID
- NCT06631014
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/742
- Conditions
- Amputation of Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Oct 2024 (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.
A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation.
Detailed description
Delayed rehabilitation may cause severe physical complications like joint contracture, muscle strength loss. Along with physical complications delayed in rehabilitation may also significantly affect psychological, economical and quality of daily life. Pakistan is a low income under developed country and major cause of amputation in here is traumatic amputation, that will effect mostly the younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be effected. There is a keen need of implementation of global rules for physical rehabilitation of amputees and disables including the duration of induction of prosthetic as well as overall physical rehabilitation after surgical and traumatic removal of limbs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Rehab Group | Experimental | Diagnostic Test: Early Rehab |
| Delayed Rehab Group | Active comparator | Combination Product: Delayed Rehab |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female below-knee amputees due to trauma and diabetes
Key exclusion criteria (2 listed)
- patients with comorbidities
- old user of prosthesis
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 |
|---|---|---|
| Early RehabThe first group of 25 Patients was fitted with Prosthesis with in 6months of duration after amputation. | Diagnostic test | Early Rehab Group |
| Delayed RehabThe 2nd group of 25 patients that was fitted with Prosthesis after the time period of 6months after amputation. No physical rehab was done during this time period including physiotherapy and prosthetic treatment. Main aim was to check the significant impact of delayed rehabilitation. | Combination product | Delayed Rehab Group |
Primary outcome
World Health Organization Quality of life (WHO QOL)
Time frame: 12 Months
questionnaire was used to measure the impact in both groups for quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. The patient's physical, psychological, social, and environmental state of health are assessed separately in WHO_QOL known as 4 domains of questionaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Rehab and Delayed Rehab in people with Amputation of Knee, run by Superior University 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. 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?
Results are not available in the source record.
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?
World Health Organization Quality of life (WHO QOL) (time frame: 12 Months). 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 8 Oct 2024.