NCT06404801

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 5, 2024

Last Update Submit

May 5, 2024

Conditions

Ankle OsteoarthritisKnee

Outcome Measures

Primary Outcomes (2)

  • 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

    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)

    12 months

Interventions

Stance ControlBEHAVIORAL

Instead of stability coming from a locked knee joint, the brace is able to lock and unlock at just the right time while walking

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

peoples selected based on having Polio or Proximal tibial fracture

You may qualify if:

  • Polio Patient
  • Proximal tibial fracture.

You may not qualify if:

  • Patients without KAFO
  • Cerebral Palsy Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peshawar North West General Hospital & Research Center

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2024

First Posted

May 8, 2024

Study Start

November 1, 2023

Primary Completion

May 1, 2024

Study Completion

September 30, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)