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Evaluation of effectiveness of IndoKnee during knee flexion and extension

Recruiting
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
Inclusion Criteria
  • 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).
Exclusion Criteria

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
NameTimeMethod
Evaluate the effectiveness of using IndoKnee during knee flexion and extension by assessing the EMG data1 Year
Analysis of EMG data shows the effectiveness or non-effectiveness of using IndoKnee1 Year
Secondary Outcome Measures
NameTimeMethod
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, India
Dr Anil Kumar Jain
Principal investigator
9829061496
pksrc@sdmh.in

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