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:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT02339220
Eligibility Criteria:
Inclusion Criteria:
\- Motor criteria will be made using an impairment-level system for characterizing the severity of an upper-extremity (UE) motor deficit based on Active Range of Motion (AROM). All UE motor criteria determinations will be made with the subject sitting. The more-affected forearm will be resting on a supporting surface (e.g. arm of chair) to allow for maximum wrist flexion with gravity. This study will treat patients at levels of Grade 2 (mild/moderate impairment) and Grade 3 (moderate impairment).
* The minimum motor criterion (MMC) for inclusion in Grade 3 (moderate impairment) will be ability to:
* Extend against gravity at least 10 degrees at the wrist from a fully flexed starting position
* Extend two or more fingers at least 10 degrees at the metacarpophalangeal (MP) joint and either the proximal or distal interphalangeal (IP) joints
* Extend or abduct the thumb at least 10 degrees
* Extend the elbow at least 20 degrees from a 90 degree flexed starting position
* Flex and abduct the shoulder at least 45 degrees
* The MMC for inclusion in Grade 2 (mild/moderate impairment) will be ability to:
* Extend against gravity at least 20 degrees at the wrist from a fully flexed starting position
* Extend all fingers at least 10 degrees at the MP joint and either the proximal or distal IP joints
* Extend or abduct the thumb at least 10 degrees
* Extend the elbow at least 20 degrees from a 90 degree flexed starting position
* Flex and abduct the shoulder at least 45 degrees
* Additionally, subjects must have substantially reduced use of the extremity in the activities of daily living as indicated by a score of less than 2.5 on the Motor Activity Log (MAL).
Note: Each movement described above must be repeated 3 times in 1 minute.
Exclusion Criteria:
* Those \< 3 months post-TBI.
* Excessive UE spasticity.
* Insufficient stamina to carry out the requirements of the therapy (based on clinical judgment).
* Medication (including psychoactive substances) will not be exclusionary except in the following cases: (If subjects are on other medications, the medications will be recorded and the possible effect on treatment outcome will be analyzed separately)
* Participation in any experimental drug field study
* Botox injections to the more-affected UE less than 3 months prior to participation
* Baclofen or Dantrium taken orally at the time of study
* Mini-Mental Status Exam (MMSE) score below 20.
* Concurrent participation in any formal physical rehabilitation program or clinical trial.
* Excessive pain in any joint of the more-affected extremity that could limit ability to cooperate with the intervention (based on clinical judgment).
* Serious, uncontrolled medical problems (e.g., cardiovascular, severe rheumatoid arthritis, serious joint deformity of arthritic origin, symptomatic cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, uncontrolled epilepsy) as judged by the Medical Director.
* Other neurological or musculoskeletal conditions affecting UE function.
* Unable to read or speak English.
* Inadequate communication skills, i.e., not able to reliably understand questions or not able to express needs or report own behavior, to participate in study based on clinical judgment.
* Substantial use of the more-affected arm in daily life as reflected by a Motor Activity Log score \> 2.5.
* Pain that interferes with use of the more-affected arm based on clinical judgment.
* A positive pregnancy test will exclude participants from MRI scanning, but would not exclude them from clinical treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02339220
Study Brief:
Protocol Section:
NCT02339220