Neurorehabilitation of the Hand

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: MyHand System Hand Rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sudbury, Ontario, Canada, P3A2TA
      • Norcat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neurorehabilitation of the Hand	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Nasa-Task Load Index (NASA-TLX)	an assessment tool used to evaluate the participant's perceived cognitive load during an activity will be used. It has six subscales; mental demand, physical demand, temporal demand, performance, effort, and frustration. To estimate the level of participant engagement, the participants score within the game/intervention, the time taken to complete a level, as well as verbal language references made during gameplay will be utilized along with the NASA-TLX sub-scores	immediately after each treatment session
ABILHAND- change is being assessed	ABILHAND a subjective functional assessment tool will be used. The tool is a 23-item survey, and participants are provided with a list of various everyday functional tasks and are scored based on patient response. For example, participant will be asked whether it is 'easy', 'difficult' or 'impossible' for each of the 23 tasks.	Baseline- prior to intervention and post- intervention- one day after completing the intervention
Jebson Taylor Hand Function Assessment-change is being assessed	7 tasks used to measure participants functional ability with they upper limbs	Baseline- prior to intervention and post- intervention- one day after completing the intervention

Collaborators and Investigators

• Sponsor: IRegained Inc.
• Collaborators: Laurentian University; Health Sciences North
• Investigators: Principal Investigator: Ratvinder Grewal, Laurentian University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 4, 2021
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (ACTUAL): September 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Motor control; Engagement; Hand Function
• Other Study ID Numbers: LUSUON0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No