Neurorehabilitation of the Hand

Sponsor
IRegained Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05549375
Collaborator
Laurentian University (Other), Health Sciences North (Other)
12
1
1
28
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MyHand System Hand Rehabilitation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Neurorehabilitation of the Hand
Actual Study Start Date :
Aug 4, 2021
Actual Primary Completion Date :
Sep 1, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. the Nasa-Task Load Index (NASA-TLX) [immediately after each treatment session]

    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

  2. ABILHAND- change is being assessed [Baseline- prior to intervention and post- intervention- one day after completing the intervention]

    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.

  3. Jebson Taylor Hand Function Assessment-change is being assessed [Baseline- prior to intervention and post- intervention- one day after completing the intervention]

    7 tasks used to measure participants functional ability with they upper limbs

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Norcat Sudbury Ontario Canada P3A2TA

Sponsors and Collaborators

  • IRegained Inc.
  • Laurentian University
  • Health Sciences North

Investigators

  • Principal Investigator: Ratvinder Grewal, Laurentian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IRegained Inc.
ClinicalTrials.gov Identifier:
NCT05549375
Other Study ID Numbers:
  • LUSUON0001
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by IRegained Inc.

Study Results

No Results Posted as of Sep 22, 2022