Neurorehabilitation of the Hand

NCT05549375 | Completed

• 1 other identifier: LUSUON0001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Hand Function; Rehabilitation; Engagement; Motor control

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Neurorehabilitation of the Hand

EXPERIMENTAL

Device: MyHand System Hand Rehabilitation

Interventions

MyHand System Hand Rehabilitation DEVICE

15 1-hour patient specific sessions using the MyHand System to help improve Hand function in the affected hand of stroke survivors

Neurorehabilitation of the Hand

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sustained a single stroke
• aged between 30-85 years of age.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRegained Inc.: lead
• Laurentian University: collaborator
• Health Sciences North: collaborator

Study Sites (1)

Norcat

Greater Sudbury, Ontario, P3A2TA, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ratvinder Grewal

  Laurentian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 22, 2022
• Study Start: August 4, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

CA (1)