Physiological Changes From Hand Movement Training

NCT05811806 | Completed

• 1 other identifier: BHMU0001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

11 participants with upper-limb impairment will be recruited from community sources. They will be invited to participate in a 15-day trial involving the IRegained device. The study will involve 2 assessment visits to Baycrest, before and after the treatment, and 15 treatment visits. The data from the pilot study will be analyzed both quantitatively and qualitatively, as outcomes and explicit feedback from participants will be used to further optimize the device for future studies.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Action Research Arm Test (ARAT)- Change is being assessed

  ARAT is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).

  Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

• ABILHAND- Change is being assessed

  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- before beginning the treatment, and Post- after the completion of 15 treatment sessions, within 5 days

• Box and Block Test (BBT)- Change is being assessed

  The BBT requires participants to move cubical wooden blocks over a partition from one box to another. Grip and pinch dynamometry will be used to assess a participant's hand strength.

  Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

Secondary Outcomes (3)

• Finger Goniometry- Change is being assessed

  Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

• Grip Dynamometry- Change is being assessed

  Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

• Pinch Dynamometry- Change is being assessed

  Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

Study Arms (1)

Neurorehabilitation of the Hand

EXPERIMENTAL

Participants will undergo a 1-hour training session 5 days per week, over 3 weeks for a total of 15 sessions. Hand function therapy will be administered using the gamified protocol to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study.

Device: Treatment using the MyHand System

Interventions

Treatment using the MyHand System DEVICE

Participants will undergo three weeks of 1-hour hand therapy with the MyHand System. The MyHand System provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy.

Neurorehabilitation of the Hand

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sustained a single stroke \>6months prior to start of study

You may not qualify if:

• Severe spasticity or contractures (2 or less in the CMSA)
• any other musculoskeletal or neuromuscular disorders that compromise sensation
• Prospective participants who are incapable of providing consent to participate in the research study will also be excluded (determined by an MMSE score of 24 or less).
• Botox Injections less than 2 months prior to starting the study

Sponsors & Collaborators

• IRegained Inc.: lead
• Baycrest: collaborator
• McMaster University: collaborator

Study Sites (1)

Baycrest Hospital

North York, Ontario, M6A 2E1, 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

• Jed Meltzer, PhD

  Baycrest Hospital

  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: September 27, 2022
• First Posted: April 13, 2023
• Study Start: May 2, 2022
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)