Motor Recovery Training for Hand and Digits in Stroke and SCI

Acute Stroke Clinical Trial

Official title: Hummingbird: Advancing Technology for Motor Recovery in Hand and Fingers for Stroke and Spinal Cord Injury

Status Not yet recruiting

Clinical 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. This study will randomize patients to either standard rehabilitation care with added study-related motor training or standard rehabilitation care alone.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Stroke
• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Stroke

• NCT number: NCT04688229
• Study type: Interventional
• Source: Shirley Ryan AbilityLab
• Contact: Connie Casale
• Phone: 312-238-1522
• Email: ccasale@sralab.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2021
• Completion date: May 27, 2022