Motor Recovery Training for Hand and Digits in Stroke and SCI

Not Applicable

• Conditions: Cervical Spinal Cord Injury; Acute Stroke
• Interventions: Other: Comparison (sham) intervention; Device: Hummingbird hand training device plus standard of care rehabilitation

• Registration Number: NCT04688229
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Study Start: 2021-10-20
• Primary Completion: 2022-02-27
• Study Completion: 2022-05-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison (sham) group	Comparison (sham) intervention	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
Hummingbird intervention group	Hummingbird hand training device plus standard of care rehabilitation	10 one-hour sessions of focused hand training (affected or dominant hand) using the Hummingbird device in addition to standard of care inpatient rehabilitation

Primary Outcome Measures

Name	Time	Method
Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) measure	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.

Secondary Outcome Measures

Name	Time	Method
Action research arm test (ARAT)	Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment	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	Baseline, 72 hours post-treatment, 2 weeks post treatment, and 3 months post treatment	Number of 2.5 cm cubes transferred over a partition in 60 seconds
Usability of the device (Intervention group only)	First day of treatment through 10th day of treatment (last treatment)	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