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Minor10 versionsRe-verified since Dec 1, 2023, no change to tracked fieldsv63-v72
MinorStart date changed from estimate of May 29, 2023 to May 2, 2023v62
MinorStart date: May 28, 2023 to May 29, 2023v61
MinorStart date: May 24, 2023 to May 28, 2023v60
MinorStart date: May 23, 2023 to May 24, 2023v59
Show 36 earlier versionsHide 36 earlier versions
MinorStart date: May 22, 2023 to May 23, 2023v58
MinorStart date: May 19, 2023 to May 22, 2023v57
MinorStart date: May 17, 2023 to May 19, 2023v56
MinorStart date: May 15, 2023 to May 17, 2023v55
MinorStart date: May 14, 2023 to May 15, 2023v54
MinorStart date: May 11, 2023 to May 14, 2023v53
MinorStart date: May 10, 2023 to May 11, 2023v52
MinorStart date: May 9, 2023 to May 10, 2023v51
MinorStart date: May 5, 2023 to May 9, 2023v50
MinorStart date: May 4, 2023 to May 5, 2023v49
MinorStart date: May 3, 2023 to May 4, 2023v48
MinorStart date: May 2, 2023 to May 3, 2023v47
MinorStart date: May 1, 2023 to May 2, 2023v46
MinorStart date: Apr 30, 2023 to May 1, 2023v45
MinorStart date: Apr 27, 2023 to Apr 30, 2023v44
MinorStart date: Apr 25, 2023 to Apr 27, 2023v43
MinorStart date: Apr 24, 2023 to Apr 25, 2023v42
MinorStart date: Apr 23, 2023 to Apr 24, 2023v41
MinorStart date: Apr 20, 2023 to Apr 23, 2023v40
MinorStart date: Apr 19, 2023 to Apr 20, 2023v39
MinorStart date: Apr 18, 2023 to Apr 19, 2023v38
MinorStart date: Apr 17, 2023 to Apr 18, 2023v37
MinorStart date: Apr 16, 2023 to Apr 17, 2023v36
MinorStart date: Apr 13, 2023 to Apr 16, 2023v35
MinorStart date: Apr 12, 2023 to Apr 13, 2023v34
MinorStart date: Apr 11, 2023 to Apr 12, 2023v33
MinorStart date: Apr 10, 2023 to Apr 11, 2023v32
MinorStart date: Apr 9, 2023 to Apr 10, 2023v31
MinorStart date: Apr 4, 2023 to Apr 9, 2023v30
NotableTrial status: Not Yet Recruiting to Recruiting
Start date: Apr 3, 2023 to Apr 4, 2023
Site details revised
v29
MinorStart date: Mar 31, 2023 to Apr 3, 2023v28
MinorStart date: Mar 30, 2023 to Mar 31, 2023v27
MinorStart date: Mar 28, 2023 to Mar 30, 2023v26
MinorStart date: Mar 27, 2023 to Mar 28, 2023v25
MinorStart date: Mar 24, 2023 to Mar 27, 2023v24
MinorStart date: Mar 22, 2023 to Mar 24, 2023v23
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.
Objective:
To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.
Eligibility:
People aged 3 to 17 years with a gait disorder involving the knee joint.
Design:
Participants will be screened. They will have a physical exam. Their walking ability will be tested.
Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.
The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.
During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.
During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.
Participants walking ability will be retested after each phase....