Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT04964635
Eligibility Criteria:
Inclusion Criteria:
* Have a spinal cord injury that has resulted in tetraplegia affecting hand function.
* Minimal spasticity of wrist muscle.
* Able to do shoulder elevation.
* Upper limb passive range of motion should be within normal limit.
* Age group: 18 years and above.
* Able to understand and comply with assessment procedures.
* Able to give informed consent.
* Able to produce a muscle contraction using electrical stimulation in sufficient muscles produce a functional grip.
Exclusion Criteria:
* Using a cardiac pacemaker, defibrillator or other sensitive implanted device.
* Pregnant or planning to become pregnant over the course of the study.
* A history of poorly controlled epilepsy.
* If there is malignancy on the hand or arm.
* If younger than 18
* Severe contracture of wrist and finger joints.
* Painful shoulder.
* Suffering from significant autonomic dysreflexia in response to FES.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04964635
Study Brief:
Protocol Section:
NCT04964635