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OpenTrials
Completed

NCT Number: NCT05549375

Neurorehabilitation of the Hand

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.

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Key information

Conditions

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

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norcat

Greater Sudbury, Ontario, P3A2TA, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. the Nasa-Task Load Index (NASA-TLX)

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRegained Inc.

Industry

Collaborators

  • Health Sciences North
  • Laurentian University

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2022
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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