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A Clinical Trial to study the safety and compliance, benefits of a orthotic device â??CYBOLIMB â?? in patients with traumatic spinal cord injury.

An Open Label Pilot study on Safety Adaptability and Compliance, Benefits of Robotic Exoskeletal Orthosis â?? CYBO LIMB, for rehabilitating spinal cord injury patients with lower limb neurological motor deficit.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006922
Enrollment
6
Registered
2016-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients with Traumatic Spinal Cord Injury with neurological motor deficit of both lower limbs

Interventions

Intervention1: Robotic Exoskeletal Orthosis: An Open Label Pilot study to assess Safety and Compliance of Robotic Exoskeletal Orthosis - in which Spinal cord injury patients with lower limb neurologic

Sponsors

Cybernoid Healthcare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Spinal Cord Injury â?? duration more than 6 months, -With normal upper limb function and good trunk balance. -Height â?? 5 â?? 6 feet -Weight - Less than 100 kgs -Ability to give informed consent

Exclusion criteria

Exclusion criteria: -Neurological Injury â?? other than Traumatic Spinal Cord injury -Debilitating concurrent medical illnesses -Recent Lower Extremity Fractures within two years -Clinical / Radiological evidence of severe osteoporosis. -Doppler Study / ECHO Cardiogram with poor Cardiac Function. -Systemic or peripheral infection -Atherosclerosis, congestive heart failure, or history of myocardial infarction -Trunk and/or lower extremity pressure ulcers -Other illness, that the study physician considers in his/her clinical judgment to be exclusionary -Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician) -Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee -Diagnosis of heterotrophic ossification of the lower extremities -Psychopathology documentation in the medical record or history of that may conflict with study objectives -Hypertension (SBP >140, DBP >90) -Pregnancy and/or lactating females

Design outcomes

Primary

MeasureTime frame
-Time Taken for training sessions to use the CYBOLIMB. During Testing Sessions - Time taken for Sit to Stand ( Up and Go) -Ten meters - timed walk - Distance walked in 6 minutes Timepoint: only during testing sessions, after training.—

Secondary

MeasureTime frame
Blood pressure changes, Pulse Rate changes, Visual Analogue Scale Scoring for Pain & Fatigue.Timepoint: every day during training and testing sessions.—

Countries

India

Contacts

Public ContactDr R Karthikeyan

Sree Balaji Medical College and Hospital

drkarthikeyanr@bharathuniv.ac.in9965578935

Outcome results

None listed

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