Neurorehabilitation of the Hand

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: MyHand System Hand Rehabilitation

• Registration Number: NCT05549375
• Lead Sponsor: IRegained Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Study Start: 2021-08-04
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurorehabilitation of the Hand	MyHand System Hand Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

Norcat; 🇨🇦 Sudbury, Ontario, Canada