Acute StrokeNCT04688229
Motor Recovery Training for Hand and Digits in Stroke and SCI
A study of Acute Stroke and Cervical Spinal Cord Injury, run by Shirley Ryan AbilityLab.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Stroke, Cervical Spinal Cord Injury
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2021to 27 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI patients
- Male and females between ages 18-75 years
- Within 1-2 months after traumatic SCI
- Cervical injury at C8 or above (tetraplegia)
- 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.
- 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
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- Stroke patients
- Males and females between ages 18-90 years
- Within 1 month after anterior circulation ischemic stroke
- 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.
- 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.
Who cannot join
- SCI patients
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Other neurological injury affecting target arm and hand
- Fracture or soft tissue injury to target arm and hand
- A pain scored greater than 3 on a 10 point scale at rest in target arm and hand
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- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- 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
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the stroke that caused exercise intolerance
- Other neurological injury affecting target arm and hand
- Fracture or soft tissue injury to target arm and hand
- Pain scored greater than 3 on a 10 point scale at rest in target arm and hand
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- Inability to follow a three-step command.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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:
- can facilitate improve hand function.
- can improve finger strength and individuation.
- 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.
- Conditions
- Acute Stroke, Cervical Spinal Cord Injury
- Being tested
- Hummingbird hand training device plus standard of care rehabilitation, Comparison (sham) intervention
- Keywords
- Motor recovery, Hand, Stroke, SCI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hummingbird hand training device plus standard of care rehabilitationDevice
The Hummingbird is a comprehensive hardware and software platform that isolates the hand, wrist, and forearm in a neutral and comfortable position, allowing linear force and angular torque to be measured at the finger-tips between 0-10 Newtons at milli-newton resolution at 100 Hz per digit, in 5 degrees of freedom simultaneously, in real-time, for all 5 digits. The platform allows isolating and characterizing fine resolution forces with sufficient sensitivity and resolution to record data in severe paralysis. The platform also comprises therapeutic software to train exploratory, individuated, and inter-digit complex finger movements by coupling force and torque output to NeuroAnimation physics-based virtual interface in engaging therapeutic experiences.
Comparison (sham) interventionOther
During each hour of sham therapy the therapist will select cognitive tasks (e.g. puzzles and games) targeted to a level of difficulty based on the subjects ability. No grasping or object manipulation using the target upper limb will be included in this intervention. Rather, the participant will use either the unaffected limb (or non-targeted limb for SCI subjects) as needed for any particular puzzle or game.
| Study group | Role | What they receive |
|---|---|---|
| Hummingbird intervention group | Experimental | 10 one-hour sessions of focused hand training (affected or dominant hand) using the Hummingbird device in addition to standard of care inpatient rehabilitation Receives: Device: Hummingbird hand training device plus standard of care rehabilitation |
| Comparison (sham) group | Active comparator | 10 one-hour sessions of activity focused on playing games or puzzles gaged to the ability of the subject in addition to Standard of care inpatient rehabilitation Receives: Other: Comparison (sham) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline,72 hours Post-treatment, 2 weeks post treatment, and 3 months post treatment
Secondary outcomes (3)
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.
Measured: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
Box and Block test
Number of 2.5 cm cubes transferred over a partition in 60 seconds
Measured: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
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
Measured: First day of treatment through 10th day of treatment (last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start20 Oct 2021 (estimated)
- Primary completion27 Feb 2022 (estimated)
- Study completion27 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study intervention vs standard of care rehabilitation in a 2:1 ratio balancing diagnostic groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Richard Harvey, Shirley Ryan AbilityLab
- Investigators
- Richard L Harvey, MD, Principal investigator, Shirley Ryan AbillityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688229
- Sponsor's protocol ID
- hummingbird
- Status last verified
- Sep 2021
- First submitted
- 21 Dec 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hummingbird: Advancing Technology for Motor Recovery in Hand and Fingers for Stroke and Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04688229
- Acronym / sponsor ID
- hummingbird
- Conditions
- Acute Stroke, Cervical Spinal Cord Injury
- Keywords
- Motor recovery, Hand, Stroke, SCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 27 Feb 2022 (estimated)
- Study completion
- 27 May 2022 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- can facilitate improve hand function.
- can improve finger strength and individuation.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized study intervention vs standard of care rehabilitation in a 2:1 ratio balancing diagnostic groups
| Arm | Type | Receives |
|---|---|---|
| Hummingbird intervention group | Experimental | Device: Hummingbird hand training device plus standard of care rehabilitation10 one-hour sessions of focused hand training (affected or dominant hand) using the Hummingbird device in addition to standard of care inpatient rehabilitation |
| Comparison (sham) group | Active comparator | Other: Comparison (sham) intervention10 one-hour sessions of activity focused on playing games or puzzles gaged to the ability of the subject in addition to Standard of care inpatient rehabilitation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- SCI patients
- Male and females between ages 18-75 years
- Within 1-2 months after traumatic SCI
- Cervical injury at C8 or above (tetraplegia)
- 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.
Key exclusion criteria (17 listed)
- SCI patients
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Other neurological injury affecting target arm and hand
- Fracture or soft tissue injury to target arm and hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hummingbird hand training device plus standard of care rehabilitationThe Hummingbird is a comprehensive hardware and software platform that isolates the hand, wrist, and forearm in a neutral and comfortable position, allowing linear force and angular torque to be measured at the finger-tips between 0-10 Newtons at milli-newton resolution at 100 Hz per digit, in 5 degrees of freedom simultaneously, in real-time, for all 5 digits. The platform allows isolating and characterizing fine resolution forces with sufficient sensitivity and resolution to record data in severe paralysis. The platform also comprises therapeutic software to train exploratory, individuated, and inter-digit complex finger movements by coupling force and torque output to NeuroAnimation physics-based virtual interface in engaging therapeutic experiences. | Device | Hummingbird intervention group |
| Comparison (sham) interventionDuring each hour of sham therapy the therapist will select cognitive tasks (e.g. puzzles and games) targeted to a level of difficulty based on the subjects ability. No grasping or object manipulation using the target upper limb will be included in this intervention. Rather, the participant will use either the unaffected limb (or non-targeted limb for SCI subjects) as needed for any particular puzzle or game. | Other | Comparison (sham) group |
Primary outcome
Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) measure
Time frame: Baseline,72 hours Post-treatment, 2 weeks post treatment, and 3 months post treatment
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.
3 secondary outcomes
Action research arm test (ARAT)
Time frame: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
Box and Block test
Time frame: Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment
Usability of the device (Intervention group only)
Time frame: First day of treatment through 10th day of treatment (last treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: Yes. IPD will be shared with investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard L Harvey, MD principal investigator
Shirley Ryan AbillityLab
Questions about this trial
What is this clinical trial studying?
A study of Acute Stroke and Cervical Spinal Cord Injury, run by Shirley Ryan AbilityLab.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Connie Casale (312-238-1522, ccasale@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) measure (time frame: Baseline,72 hours Post-treatment, 2 weeks post treatment, and 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.