Clinical trial NCT04688229: Motor Recovery Training for Hand and Digits in Stroke and SCI
Official title: Hummingbird: Advancing Technology for Motor Recovery in Hand and Fingers for Stroke and Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stroke
Cervical Spinal Cord Injury
Keywords: Motor recovery
Hand
Stroke
SCI
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2020-12-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study intervention vs standard of care rehabilitation in a 2:1 ratio balancing diagnostic groups
Primary purpose: TREATMENT

Brief summary: This study will use evaluate a hand therapy device training isolated finger control with engaging video gaming technology to facilitate hand and digit recovery in patients with acute stroke and cervical spinal cord injury. This study will randomize patients to either standard rehabilitation care with added study-related motor training or standard rehabilitation care alone.

Detailed description: The purpose of this project is to develop a usable bedside hand therapy device that that takes advantage of early neuroplasticity following stroke and cervical spinal cord injury (SCI), to retrain functionally relevant movement in individual fingers of the neurologically impaired hand. It is well established in neuroscience that neural recovery and neuroplasticity at the level of cortex in animals and humans is dependent on active motor practice. In this pilot project the investigators will determine and assure that this second-generation device, which has not yet been used in humans, is usable in the clinical setting and that patients with stroke and cervical SCI find it a meaningful tool for relearning hand movement. The investigators will also assess whether use of the device daily for 2 weeks results in improved functional hand use, improve finger strength and improved ability to control individual finger movements. Although these abilities are foundational to functional manipulation of objects with the hand, there is presently no specific therapeutic interventions, nor time available in conventional early (acute) rehabilitation to address these goals. Thus, early intensive hand recovery is an obvious but unmet need in neurorehabilitation. The goals for this one-year project are determine if the device:

1. can facilitate improve hand function.
2. can improve finger strength and individuation.
3. is usable in a clinical setting and serves as a meaningful therapy tool to patients with stroke and cervical SCI.

If successful, this project will lead to a refined therapy protocol in preparation for a larger clinical trial to establish efficacy of this training approach for both stroke and cervical spinal cord injury. Both stroke and SCI populations were chosen as this tool could potentially have benefit for both groups. In addition, studying both patient populations provides generalizability to a wider group of individuals needing rehabilitation. If outcomes are suggestive of efficacy this device will evaluated in a large multi-center pivotal trial in preparation for transition to the clinical marketplace as new rehabilitation technology that has proven scientific evidence supporting its efficacy in early hand rehabilitation.

Eligibility criteria: Inclusion Criteria:

SCI patients

1. Male and females between ages 18-75 years
2. Within 1-2 months after traumatic SCI
3. Cervical injury at C8 or above (tetraplegia)
4. Categorized by the American Spinal Cord Injury Impairment Scale (AIS) as AIS A, B, C and D. Individuals with AIS A and B will be included if they score a minimum of 1 on the "Prehension Ability" GRASSP and are able to generate 0.01N with at least one finger in dominant or non-dominant hand using the Hummingbird device.
5. Intact (level 2), impaired (level 1) or absent (level 0) lower motor neuron innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the ISNCSCI sensory scores, and

Stroke patients

1. Males and females between ages 18-90 years
2. Within 1 month after anterior circulation ischemic stroke
3. Ability to score a minimum of 1 on the "Prehension Ability" GRASSP and are able to generate 0.01N with at least one finger in hemiparetic hand using the Hummingbird device.
4. Ability to initiate elbow flexion and extension in hemiparetic arm with gravity removed.

6. Ability to perform reaching movements towards an object at a 8 cm distance in front and above.

Exclusion Criteria:

SCI patients

1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
2. Any debilitating disease prior to the SCI that caused exercise intolerance
3. Other neurological injury affecting target arm and hand
4. Fracture or soft tissue injury to target arm and hand
5. A pain scored greater than 3 on a 10 point scale at rest in target arm and hand
6. Premorbid, ongoing major depression or psychosis, altered cognitive status
7. History of head injury or stroke
8. Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.

Stroke patients

1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
2. Any debilitating disease prior to the stroke that caused exercise intolerance
3. Other neurological injury affecting target arm and hand
4. Fracture or soft tissue injury to target arm and hand
5. Pain scored greater than 3 on a 10 point scale at rest in target arm and hand
6. Premorbid, ongoing major depression or psychosis, altered cognitive status
7. Inability to follow a three-step command.

Primary outcomes:
measure: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) measure
timeFrame: Baseline,72 hours Post-treatment, 2 weeks post treatment, and 3 months post treatment
Secondary outcomes:
measure: Action research arm test (ARAT)
timeFrame: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
measure: Box and Block test
timeFrame: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
measure: Usability of the device (Intervention group only)
timeFrame: First day of treatment through 10th day of treatment (last treatment)
Other outcomes:
measure: Maximum voluntary force (MVF) by each of 5 digits
timeFrame: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
measure: Average strength index all digits
timeFrame: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
measure: Individuation index
timeFrame: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
Locations:
Study officials:
affiliation: Shirley Ryan AbillityLab
name: Richard L Harvey, MD
role: PRINCIPAL_INVESTIGATOR
References: