Neurorehabilitation of the Hand

NCT ID: NCT05549375

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2021-09-01

Brief Summary

Stroke is the number one cause of adult disability in the world. Due to the neurological damage from stroke, a vast majority of individuals suffer from hand function disability (~70%). To improve hand function and overcome challenges from this disability, IRegained has developed the MyHandTM system, a connected mechatronic device with programmed proprietary hand function training protocols developed through deep research in neuroplasticity that provide targeted hand function therapy. When these therapeutic protocols are provided in a gamified format, it enhances the patient engagement and motivation, thereby enabling effective therapy administration with the required intensity and repetition to improve hand function. Participants who have sustained a stroke 6 months or earlier will be eligible to participate in this study, and will undergo hand function therapy for one 1-hour/session, 5 times/week, over a 3-week duration, for a total of 15 sessions. Therapy will be administered through with specific hand functions in a gamified format to enhance greater function in the hand and thereby help patients gain greater independence in performing activities of daily living. This research project will aim to understand the extent to which this approach to therapy impacts patient motivation and engagement in order to develop the most efficient and effective mode of therapy.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurorehabilitation of the Hand

Group Type: EXPERIMENTAL

MyHand System Hand Rehabilitation

Intervention Type: DEVICE

15 1-hour patient specific sessions using the MyHand System to help improve Hand function in the affected hand of stroke survivors

Interventions

MyHand System Hand Rehabilitation

15 1-hour patient specific sessions using the MyHand System to help improve Hand function in the affected hand of stroke survivors

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• sustained a single stroke
• aged between 30-85 years of age.

Exclusion Criteria

• Participants with severe spasticity or contractures,
• have other musculoskeletal or neuromuscular disorders that compromises sensation or other neuromuscular parameters
• participants who are unable to provide consent to participate

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laurentian University

OTHER

Sponsor Role: collaborator

Health Sciences North

OTHER

Sponsor Role: collaborator

IRegained Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ratvinder Grewal

Role: PRINCIPAL_INVESTIGATOR

Laurentian University

Locations

Norcat

Greater Sudbury, Ontario, Canada

Countries

Canada

Other Identifiers

LUSUON0001

Identifier Type: -

Identifier Source: org_study_id