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NCT Number: NCT06854978

R3THA Rehabilitation Feasibility and Usability Study

The purpose of this study is to assess how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.

Recruiting

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location status: Recruiting

Location contact

Kiran Karunakaran, PhD

CONTACT

[email protected]

973-324-3590

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • must be between the ages of 20 and 80
  • must have enough movement in my arms and hands to actively interact with the video games as determined by study staff
  • must have internet access at home.
  • must be comfortable performing basic functions on a computer, such as browsing the internet.
  • must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff.

Exclusion criteria

Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff.

  • Thinking problems or have difficulty following instructions 3) Unable to interact with an entire computer screen due to spatial neglect 4) Difficulty understanding words spoken to me (Receptive aphasia) 5) Any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) Severe arthritis that limits hand and arm movements 7) Not independent in functional activities/mobility prior to stroke

Treatment and study plan

RETHA

Other

The study will enroll up to 10 participants with stroke who will be paired with trained therapists to receive R3THA telerehabilitation. The participants with stroke will participate in 7 training sessions. The training includes hand and arm exercises.

Primary outcomes

  1. System Usability Survey

    Time frame: 5 weeks

    System Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.

  2. Exergame Questionnaire

    Time frame: 5 weeks

    It is a questionnaire developed to assess qualitative performance of the device

  3. Performance Survey

    Time frame: 5 weeks

    It is a qualitative questionnaire with interview aimed at gauging the feasibility of integrating R3THA into the daily routines of individual with stroke/end users.

  4. Fugl-Meyer Assessment for Upper Extremity

    Time frame: 5 weeks

    A standard clinical measure to assess the level of motor impairment in individuals with stroke.

  5. Box and Blocks Test

    Time frame: 5 weeks

    box and blocks test is standard measure for hand dexterity and hand-eye coordination

  6. Action Research Arm Test

    Time frame: 5 weeks

    The standard assessment for functional performance in individuals with stroke

  7. Kinematic Assessment

    Time frame: 5 weeks

    Kinematic assesment to measure range of motion of the hand and arm

Secondary outcomes

  1. Montreal Cognitive Assessment Test (MOCA)

    Time frame: 1 week

    30-item question to assess cognitive impairment in people with stroke. The score ranges from 0 to maximum score of 30. Score of 30 denotes high cognitive function while 0 is low cognitive function

Study contacts

Contact information is provided by the study sponsor or research team.

Kiran Karunakaran, PhD

CONTACT

[email protected]

973-324-3590

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Acronym: RETHA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

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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