Evaluation of effectiveness of IndoKnee during knee flexion and extension
- Conditions
- Normal Healthy Person with BMI between 18 to 30, and age between 18 to 70 years with height between 145 to 180 cm who can frequently perform knee flexion and extension tasks.
- Registration Number
- CTRI/2019/07/020059
- Lead Sponsor
- Newndra Innovations Pvt Ltd
- Brief Summary
The study is a non-randomized, single arm, single center trials on 30 subjects in India during knee flexion and extension tasks like sitting down from standing position and standing up from seated position without using the IndoKnee and with using the IndoKnee.
The primary objective of trial is to evaluate the effectiveness of IndoKnee during knee flexion and extension tasks by assessing the EMG data. The secondary objective of trails is to assess the ease of use, risks & adverse effect and get feedback of the device. Other objective is to understand the gap between device and requirements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
- Healthy Male and Female subjects.
- Age should be between 18 years to 70 years Height should be between 145cm to 180cm Normal Healthy Person (BMI should be between18 to 30).
Cases of known or suspected knee injury, Knee replacement, Knee surgery Subjects underwent surgery or advised not to squat Pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the effectiveness of using IndoKnee during knee flexion and extension by assessing the EMG data 1 Year Analysis of EMG data shows the effectiveness or non-effectiveness of using IndoKnee 1 Year
- Secondary Outcome Measures
Name Time Method To assess the ease of use, risks and adverse effects and get feedback for the device, understand the gap between device and user requirements. 1 Year
Trial Locations
- Locations (1)
Dr. P.K. Sethi Department of Physical Medicine and Rehab
🇮🇳Jaipur, RAJASTHAN, India
Dr. P.K. Sethi Department of Physical Medicine and Rehab🇮🇳Jaipur, RAJASTHAN, IndiaDr Anil Kumar JainPrincipal investigator9829061496pksrc@sdmh.in