Ankle OsteoarthritisNCT06404801
Development of Stance Control Orthotic Knee Joint For Improvement of KAFO Users
An observational study of Ankle Osteoarthritis and Knee, run by Superior University at 1 site in Pakistan.
Trial summary
I want to design Stance control orthotic knee joint for improvement of KAFO users which is not available in Pakistan imported stance control orthotic knee joints are very expensive patients can't afford. The aim of my study to develop low cost stance control knee joint and ensure its availablity for KAFO users. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Ankle Osteoarthritis, Knee
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Sep 2024
- Phase
- Observational
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: peoples selected based on having Polio or Proximal tibial fracture
Who may be able to join
- Polio Patient
- Proximal tibial fracture.
Who cannot join
- Patients without KAFO
- Cerebral Palsy Patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Peshawar North West General Hospital & Research Center
Peshawar, Khyber Pakhtunkhwa
About this study
I want to design Stance control orthotic knee joint for improvement of KAFO users which is not available in Pakistan imported stance control orthotic knee joints are very expensive patients can't afford. The aim of my study to develop low cost stance control knee joint and ensure its availablity for KAFO users.
- Conditions
- Ankle Osteoarthritis, Knee
- Being tested
- Stance Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stance ControlBehavioural
Instead of stability coming from a locked knee joint, the brace is able to lock and unlock at just the right time while walking
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Through Questionnaire
Through Questionnaire used to ask after the use of stance control to messure the pain in the pionts used in questioner
Measured: 12 Months
SF-36
physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
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 May 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 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
- NCT06404801
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/706
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Stance Control Orthotic Knee Joint For Improvement of KAFO Users
- ClinicalTrials.gov ID
- NCT06404801
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/706
- Conditions
- Ankle Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 May 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.
I want to design Stance control orthotic knee joint for improvement of KAFO users which is not available in Pakistan imported stance control orthotic knee joints are very expensive patients can't afford. The aim of my study to develop low cost stance control knee joint and ensure its availablity for KAFO users.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- peoples selected based on having Polio or Proximal tibial fracture
Key inclusion criteria (2 listed)
- Polio Patient
- Proximal tibial fracture.
Key exclusion criteria (2 listed)
- Patients without KAFO
- Cerebral Palsy Patients
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 |
|---|---|---|
| Stance ControlInstead of stability coming from a locked knee joint, the brace is able to lock and unlock at just the right time while walking | Behavioural | – |
Primary outcome
Patient Satisfaction Through Questionnaire
Time frame: 12 Months
Through Questionnaire used to ask after the use of stance control to messure the pain in the pionts used in questioner
SF-36
Time frame: 12 months
physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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?
An observational study of Ankle Osteoarthritis and 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 2 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 May 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?
Patient Satisfaction Through Questionnaire (time frame: 12 Months). The study lists 2 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 8 May 2024.