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A comparison between gravity-operated and spring-assisted knee lock for KAFO

EZ-LOCK Orthosis

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053486
Enrollment
20
Registered
2023-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G14- Postpolio syndrome

Interventions

Intervention1: EZ-LOK - Knee Joint Lock: Cable-operated, Spring loaded type of Knee-Joint lock for Knee Ankle Foot Orthosis (KAFO) After a pre-intervention assessment of activities with the EZ-LOCK,

Sponsors

TTK CenteR for Rehabilitation Research and Device Development, IIT Madras
Lead Sponsor
Mobility India
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1) Quadriceps muscle weakness with (MRC 2) People who independently walk with unilateral/bilateral KAFO for at least 100 m 3) People who transfer independently with unilateral/bilateral KAFO 4) Upper limb strength sufficient to operate the new knee joint 5) Over 1 m tall

Exclusion criteria

Exclusion criteria: 1) Impaired cognition 2) Impaired perception 3) Fair to poor standing balance when using unilateral/bilateral KAFO 4) Acute pain in hip, knee and ankle joint 5) Knee flexion contracture greater than 10° 6) Pregnant women 7) Children 8) Abnormal BP 9) Orthostatic hypotension 10) Cardio vascular condition 11) Severe osteoarthritis 12) Standing endurance less than 15 minutes 13) Sensory impairment 14) Poor coordination 15) Poor dexterity

Design outcomes

Primary

MeasureTime frame
Ease of Use and Reliability of lockingTimepoint: Pre-Intervention - Evaluation to be done on day 0 Post-Intervention - To be done 21 days after evaluation Follow up - To be done 30 days after evaluation

Secondary

MeasureTime frame
Actuation SpeedTimepoint: Pre-Intervention - Evaluation to be done on day 0 Post-Intervention - To be done 21 days after evaluation Follow up - To be done 30 days after evaluation;Gait StabilityTimepoint: Pre-Intervention - Evaluation to be done on day 0 Post-Intervention - To be done 21 days after evaluation Follow up - To be done 30 days after evaluation

Countries

India

Contacts

Public ContactDr Sujatha Srinivasan

Indian Institute Of Technology, Madras

sujsree@iitm.ac.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026