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Neurorehabilitation of the Hand

Neurorehabilitation of the Hand

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05549375
Enrollment
12
Registered
2022-09-22
Start date
2021-08-04
Completion date
2021-09-01
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Hand Function, Rehabilitation, Engagement, Motor control

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.

Interventions

DEVICEMyHand 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

Sponsors

Laurentian University
CollaboratorOTHER
Health Sciences North
CollaboratorOTHER
IRegained Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
the Nasa-Task Load Index (NASA-TLX)immediately after each treatment sessionan 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 assessedBaseline- prior to intervention and post- intervention- one day after completing the interventionABILHAND 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 assessedBaseline- prior to intervention and post- intervention- one day after completing the intervention7 tasks used to measure participants functional ability with they upper limbs

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026