Neurorehabilitation of the Hand

Stroke Clinical Trial

Official title:

Neurorehabilitation of the Hand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549375
• Other study ID #: LUSUON0001
• Status: Completed
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2022
• Source: IRegained Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Canada	Norcat	Sudbury	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
IRegained Inc.	Health Sciences North, Laurentian University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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