Acute Stroke Clinical Trial
Official title:
Hummingbird: Advancing Technology for Motor Recovery in Hand and Fingers for Stroke and Spinal Cord Injury
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | May 27, 2022 |
Est. primary completion date | February 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Shirley Ryan AbilityLab | Johns Hopkins University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Maximum voluntary force (MVF) by each of 5 digits | participants are asked to depress one ?nger at a time with maximum strength, and to maintain this force level for 2 seconds (measured in Newtons) | Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment | |
Other | Average strength index all digits | the average force for all 5 digits. All MVF values are normalized by the MVF of the non-targeted hand (measured in Newtons) | Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment | |
Other | Individuation index | participants press only one ?nger at a sub-MVF force level while at the same time keeping other ?ngers immobile on the keys. Four target force levels are tested for each ?nger: 20 percent, 40 percent, 60 percent, and 80 percent of MVF. Higher index scores indicate better finger individuation. | Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment | |
Primary | Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) measure | Hand function test with 5 subtests including dorsal sensation (score 0-12), palmer sensation (score 0-12), strength (score 0-50), prehension ability (score 0-12) and prehension performance (score 0-30). Higher scores indicate better performance. | Baseline,72 hours Post-treatment, 2 weeks post treatment, and 3 months post treatment | |
Secondary | Action research arm test (ARAT) | 19-item measure divided into 4-subtests (grasp, grip, pinch, and gross arm movement). Scored 0-57 with higher score indicating better performance. | Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment | |
Secondary | Box and Block test | Number of 2.5 cm cubes transferred over a partition in 60 seconds | Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment | |
Secondary | Usability of the device (Intervention group only) | Finger strikes will be counted in each session. Usability will be defined by an increase of 50% or more of finger strikes per session over 10 treatment sessions | First day of treatment through 10th day of treatment (last treatment) |
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