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Motor Recovery Training for Hand and Digits in Stroke and SCI

Primary Purpose

Acute Stroke, Cervical Spinal Cord Injury

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Hummingbird hand training device plus standard of care rehabilitation

Comparison (sham) intervention

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Motor recovery, Hand, Stroke, SCI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Exclusion Criteria:

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
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hummingbird intervention group

Comparison (sham) group

Arm Description

10 one-hour sessions of focused hand training (affected or dominant hand) using the Hummingbird device in addition to standard of care inpatient rehabilitation

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Box and Block test

Number of 2.5 cm cubes transferred over a partition in 60 seconds

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

Full Information

NCT ID

NCT04688229

First Posted

December 21, 2020

Last Updated

September 20, 2021

Sponsor

Shirley Ryan AbilityLab

Collaborators

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT04688229

Brief Title

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

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 20, 2021 (Anticipated)

Primary Completion Date

February 27, 2022 (Anticipated)

Study Completion Date

May 27, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shirley Ryan AbilityLab

Collaborators

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke, Cervical Spinal Cord Injury

Keywords

Motor recovery, Hand, Stroke, SCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized study intervention vs standard of care rehabilitation in a 2:1 ratio balancing diagnostic groups

Masking

Outcomes Assessor

Masking Description

Outcome assessors with collect outcome measures in a lab area separate from treatment location. Outcome assessors have no role in randomization or treatment

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hummingbird intervention group

Arm Type

Experimental

Arm Description

10 one-hour sessions of focused hand training (affected or dominant hand) using the Hummingbird device in addition to standard of care inpatient rehabilitation

Arm Title

Comparison (sham) group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Hummingbird hand training device plus standard of care rehabilitation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Comparison (sham) intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) measure

Description

Time Frame

Baseline,72 hours Post-treatment, 2 weeks post treatment, and 3 months post treatment

Secondary Outcome Measure Information:

Title

Action research arm test (ARAT)

Description

19-item measure divided into 4-subtests (grasp, grip, pinch, and gross arm movement). Scored 0-57 with higher score indicating better performance.

Time Frame

Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment

Title

Box and Block test

Description

Number of 2.5 cm cubes transferred over a partition in 60 seconds

Time Frame

Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment

Title

Usability of the device (Intervention group only)

Description

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

Time Frame

First day of treatment through 10th day of treatment (last treatment)

Other Pre-specified Outcome Measures:

Title

Maximum voluntary force (MVF) by each of 5 digits

Description

participants are asked to depress one ﬁnger at a time with maximum strength, and to maintain this force level for 2 seconds (measured in Newtons)

Time Frame

Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment

Title

Average strength index all digits

Description

the average force for all 5 digits. All MVF values are normalized by the MVF of the non-targeted hand (measured in Newtons)

Time Frame

Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment

Title

Individuation index

Description

participants press only one ﬁnger at a sub-MVF force level while at the same time keeping other ﬁngers immobile on the keys. Four target force levels are tested for each ﬁnger: 20 percent, 40 percent, 60 percent, and 80 percent of MVF. Higher index scores indicate better finger individuation.

Time Frame

Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Exclusion Criteria: 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Connie Casale

Phone

312-238-1522

ccasale@sralab.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard L Harvey, MD

Organizational Affiliation

Shirley Ryan AbillityLab

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will be shared with investigators upon request.

IPD Sharing Time Frame

3 months after completion of final data collection on last subject

IPD Sharing Access Criteria

Request in writing via email to principle investigator rharvey@sralab.org

Learn more about this trial

Motor Recovery Training for Hand and Digits in Stroke and SCI

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